Nichole Roderique currently serves as an Associate Clinical Project Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. She has over 12 years of clinical research experience working as a Clinical Data Coordinator, Clinical Research Associate, and Clinical Research Specialist.
Prior to joining the Proxima team, Nichole was a Clinical Research Specialist at Spectrum Health Systems. During her time at Spectrum Health, Nichole was responsible for overseeing and managing the Neurosciences study portfolio. Before her time at Spectrum Health, Nichole worked at Quintiles as a Clinical Data Coordinator supporting multiple different service lines such as oncology, musculoskeletal disease, and renal disorders. Additionally, she held the role as Clinical Research Associate at the Kansas City Community Clinical Oncology Program, where she worked on various oncology studies including, breast, myeloma, liver, brain, prostate, and lung to name a few.
Nichole graduated from Park University in Kansas City, MO with a Bachelor of Science in Social Psychology. Nichole also has a professional certificate, ACRP-CP, from the Association of Clinical Research Professionals.
Devin Finch currently serves as the Creative Director at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Previously, he’s been at the helm of various aspects of multimedia design, animation, and video production over the past 9 years. Devin served as the Multimedia Designer for 3 Men Movers after a long run of serving as a Graphic Designer at Sky High Party Rentals. Aside from those in-house positions, he has done animation and graphics for various agencies, restaurants, bars, and several other companies.
Kristen is a Clinical Project Manager at Proxima Clinical Research, a partner for the emerging biotech and medical device industry. Over her career, Kristen has served the medical community in a variety of roles. She started her career in the hospital setting within radiology as a CT and MRI technologist involved in routine imaging, interventional procedures and trauma. She then moved into the clinical research industry and has managed projects at a CRO, central laboratory and home trial service company. She has had the opportunity to work in a variety of indications and phases within device and drug.
Kristen received an Associates in Applied Science after becoming a Registered Radiologic Technologist. She then went on to obtain registered certifications in Computed Tomography and Magnetic Resonance Imaging.
Megan Alaniz is a Clinical Project Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
For many years, she practiced as a clinical audiologist and speech-language pathologist before transitioning into trial management six years ago. Prior to joining Proxima, Megan worked as an in-house clinical project manager for Cochlear Americas, where she designed and led the multicenter trials that secured the first FDA approval for remote programming of cochlear implants and lowered the approved age for cochlear implantation from 12m to 9m. While in this role, Megan wrote regulatory submissions and article manuscripts, and worked closely with investigators at large universities and hospitals on podium and publication strategy.
Megan received her undergraduate and master’s degrees in Communication Sciences and Disorders from Baylor University. She completed her doctorate in Audiology at the University of Texas at Dallas.
Jeanelle Lopez currently serves as the Quality Assurance Specialist at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. She supports and maintains compliance with all company documents, files, and required training. Ms. Lopez started as a Regulatory Project Coordinator with Proxima and was responsible for coordinating and tracking statuses on all regulatory projects.
Prior to joining the Proxima team, Jeanelle worked in the Oil and Gas Industry as a Project Lead focusing on Quality Control and Compliance and served as a Communications Operations Specialist. She dedicated her attention to process analysis for improvements on delivery time. One of the roles Jeanelle held was Document Control Lead, where she was charged with overseeing project progress to ensure division goals were met while governing the preparation, maintenance, and quality control of documents.
Jeanelle Lopez has a Master degree in Business Administration, with a focus in Global Management, from the University of Houston – Victoria. Jeanelle also participates as a Houston Chapter Member for Ellevate Network to promote professional development and in her spare time, she volunteers for the American Heart Association helping communities with fundraisers.
Taylor Lunsford, MGA is a Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. He has contributed to a wide range of regulatory and clinical projects, including regulatory strategies, pre-submission meetings, clinical study synopses, and regulatory agency submissions.
Taylor is particularly experienced in working with wearables, machine learning, and innovative cardiovascular devices, but has worked with devices ranging from in vitro diagnostics and implantable devices to robotics and oncological devices. He is also familiar with the regulatory environments for medical devices in Japan, China and the European Union. Taylor is fluent in Mandarin Chinese and has a strong background in medical interpreting and translating medical documents. Before joining Proxima, Taylor served in the Army as an intelligence analyst, instructor, translator and small-unit leader.
Ellie Reynolds currently serves as a Regulatory and Quality Assurance Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Prior to joining Proxima, Ellie worked for a small life sciences consulting firm, where she performed market landscape assessments and provided strategic insights to major pharmaceutical companies. Ellie has a Masters in Bioengineering, with a focus in Global Medical Innovation, from Rice University and has worked on multiple medical devices from need identification through the entire development process. She has also served in additional regulatory affairs and quality assurance roles in which she developed regulatory and technical transfer strategies for both medical device and pharmaceutical companies across a range of therapeutic areas.
Carmen Brown currently serves as the Regulatory Affairs Associate II at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Prior to joining the Proxima team, Carmen served as the QC Stability Coordinator for a biopharmaceutical company where she designed and managed a robust stability program. She led the Quality Process Improvement Team and assisted in Regulatory filings. Carmen also served in additional Stability Coordinator roles, where she was a Qualified Trainer and assisted in ANDA regulatory submissions. Mrs. Brown has also held a role as a QC Analyst, where she performed routine and non-routine testing on QC samples, gaining experience in method development and validation, and cGMP.
Christa Elliot currently serves as the Finance Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. Christa began her 15-year accounting career in oil & gas in Houston, Texas. In 2016, she joined a Houston-based CRO and learned every aspect of the inner workings of the industry.
With a passion for problem solving and unyielding attention to detail, Christa consistently strives to implement cost effective and time efficient improvements in both the accounting and operational processes. With the creation of simple to complex templates, Christa helps streamline the often tedious accounting workflows bringing in time saving and error reducing automation.
In her free time, Christa enjoys gardening and growing her own vegetables and fruits. She also loves traveling with her family and attending live concerts and music festivals. An avid game show and trivia lover, she never misses an episode of Wheel of Fortune and vows to one day appear on televisions across the country going for the grand prize!
Ms. Box currently serves as a Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development.
Prior to joining the Proxima team, Olivia was employed as a Product Engineer in the lumber production industry. In this position, she was charged with producing engineering drawings and solid models, technical documentation, such as creating company procedures and quality assurance protocols, and conducting design reviews. Olivia has a Bachelors in Engineering Science and Mechanics, with concentration in Biomechanics from Virginia Tech. As a student, she held leadership positions on multiple medical device design teams, in addition to working as an Undergraduate Research Assistant and a mentor to incoming transfer students at the university.
Syd Wiggins currently serves as a Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. At Proxima, she works on various medical device and drug product consulting projects and submissions across all stages of development, including 510(k), BDD, EUA, and IND submissions.
Syd has research experience in biomaterials, polymer chemistry, immunology, drug development and delivery, regenerative medicine, and tissue engineering. Prior to joining the Proxima team, Syd received her Masters in Biomedical Engineering from the University of Florida, where her research aimed to develop immunomodulatory biomaterials for allogeneic transplantation. Additionally, Syd has been involved in research evaluating triple-negative breast cancer cell receptor kinetics, biomarkers and in vitro diagnostic devices for traumatic brain injury, optimization of gold nanoparticle synthesis, and transaortic valve replacement design.
Syd is passionate about translating medical research from the benchtop to the bedside. She enjoys engaging with startups and is eager to assist with the advancement of innovative technologies in health care.
Jayci Blackburn serves as the Office Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. Previous to Proxima, Jayci gained administrative experience working at the respectable companies Beal Bank and Abundant Solutions. At Proxima, Jayci thoroughly manages the Human Resources department by onboarding new hires, exiting employees, assisting IT with new employee set-up, managing employee benefits, administering pay and PTO, and enforcing company policies. Jayci goes above and beyond by graciously making herself available to perform tasks outside of her regular duties.
Paul Lewis currently serves as Senior Statistician at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
He has almost 20 years of experience in clinical research and previously served as Vice President and Senior Statistician at SYNERGOS, Inc., which was acquired by inVentiv Health (VTIV) in 2006. He later served as COO and owner at Emily Graham, DDS PC. Through his consulting experience, he has advised many life sciences companies on statistical methodologies, regulatory affairs, and clinical product development, and has represented clients at the FDA.
Mr. Lewis holds a B.S. in Mathematics and an M.S. in statistics from Stephen F. Austin State University and has completed the course work and qualifying examinations for the PhD degree in Biometry from the University of Texas Health Science Center in Houston, School of Public Health. He has served on the Texas Emerging Technology Fund’s Gulf Coast Regional Center for Innovation and Commercialization (GCRCIC) Advisory Committee. He has also served as an advisor on the Houston Technology Center’s (now Houston Exponential) Life Sciences Screening Committee. He has been involved in numerous clinical trials for medical device and pharmaceutical companies pursuing marketing indications and provided statistical support for NDAs, PMAs, INDs, IDEs, and 510(k) submissions and has participated in several FDA advisory panel meetings. He has co-authored several academic papers, posters, and abstracts.
Prior to his work in clinical research, Mr. Lewis was a Senior Scientist for Team Environmental Services (formerly Source Environmental Sciences), a company assisting clients to meet regulatory and compliance guidelines for their air, water, and waste emissions. During this time, he received his Registered Environmental Manager credentials through the National Registry of Environmental Professionals. Mr. Lewis also served on the faculty in the Department of Mathematics and Statistics at Stephen F. Austin State University.
Lacy Jordan is the Site Payments Manager at Proxima Clinical Research, Inc., a contract research organization that serves the emerging biotech and medical device industries. Lacy has over 8 years of experience working with site payment management. She worked for a small CRO from 2013 - 2021, starting as a Finance Assistant and then working her way up into the role of Investigator Payments Manager. Throughout her CRO career, Lacy has been responsible for the management and development of the site payment process from beginning to end. She has been responsible for the creation of multiple templates and tools, including a detailed site payment tracking tool used to manage site payments.
In her free time, Lacy enjoys traveling with her family and attending her children’s sporting events.
Mrs. Adkison is a Clinical Research Associate II of Proxima Clinical Research a partner for the emerging biotech and medical device industry. Mrs. Adkison has served in a number of clinical research roles. Previously, as a Clinical Research Associate with PPD, she gained extensive experience in overseeing all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits. As a Project Manager with Mary Crowley, she has proven excellence in administering all clinical aspects of clinical studies and recommending changes in implementation of various plans, designing all project metrics and timeframe for project completion. She has been involved in numerous clinical trials for both investigator-initiated trials and pharmaceutical companies.
Mrs. Adkison graduated from Louisiana State University with a Bachelor of Science in Human Development. She has been involved in numerous clinical trials for both investigator-initiated trials and pharmaceutical companies.
Chelsea Isaac currently serves as a Business Development Strategist at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. At Proxima, Chelsea works to support strategic business initiatives and partnerships with operational team leads and our marketing strategist. She also serves as a client advocate, putting innovators in touch with our industry and subject matter experts.
Prior to joining the Proxima team, Chelsea was the SaaS product manager for a continuing medical education software where she led cross-functional teams to define and prioritize product requirements. In that role, she contributed to marketing, product, and operational strategic planning. She also spent many years as an independent consultant in a variety of industries for business, branding, marketing, design, and content creation. Chelsea has over a decade of experience in a variety of operational settings.
Joel currently serves as a Regulatory Affairs Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Prior to joining Proxima, Joel worked as an undergraduate research assistant at the Veterans Administration in Waco, where he aided in advancing our understanding of neurological deficits seen in the veterans with traumatic brain injuries in the neuroimaging core. Throughout his experience at Proxima, Joel has developed his skills to advise companies in the best path forward in the development of drugs and devices across a range of therapeutic and diagnostic areas.
Ms. Bristow currently serves as the Clinical Data Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Kathleen has worked in a variety of data roles at various companies. Kathleen has assisted in many aspects of data management including database design, implementation, training, data entry, study lock, development of study documents.
Kathleen Bristow has a Master’s in Business Administration and volunteers many hours to her local animal shelter, a non-for-profit homeless program in Denver and the local senior center. She also donates time to BCAN, the Bladder Cancer Advocacy Network.
Maureen currently serves as a Clinical Trial Assistant at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Maureen has experience in clinical research and has worked in multiple positions in her career. Prior to joining Proxima, she worked for a pharmaceutical company focused on men & women's reproductive health. There she was an assistant to the Office Manager & CFO, regulatory & file keeping personnel, and a data analyst.
Maureen attended the University of Texas at San Antonio, where she received a Bachelor of Science degree in Health.
Dr. Brian Rundle is an Associate Project Manager at Proxima Clinical Research and oversees several exciting ongoing trials. He has worked in research for over 12 years and was recently the research project manager for the largest cancer initiative at Baylor Scott & White Research Institute. Before this, he managed an international research consortium on post-traumatic epilepsy at the David Geffen School of Medicine at UCLA, where he worked on identifying biomarkers and pharmacotherapies. Dr. Rundle was nominated for best professor at the State University of New York in Oswego and has taught several courses in neuroanatomy, biopsychology, experimental design, and psychology. He has consulted for different scientific and medical fields including statistics, history of medicine, and chemistry education. Additionally, he began his scientific career training primates for the UT Health Science Center in San Antonio, TX.
Dr. Rundle received his Ph.D. in Behavioral Neuroscience from Baylor University and completed a postdoctoral fellowship in neurology at the UCLA School of Medicine. He has earned his Project Management Professional certification. He has been a professor of biopsychology in the Department of Psychology at the State University of New York in Oswego, and has taught many courses including Neuroanatomy, Behavioral Pharmacology, and Experimental Design. Ultimately, he has worked in research for over twelve years in various fields. He has had two successful, personal business ventures in personal fitness training and artisanal woodwork/fabrication. Dr. Rundle is passionate about team leadership, intellectual growth, and scientific discoveries.
Keegan Kelly currently serves as a Business Development Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. At Proxima, Keegan works to support emerging companies in the biotech space by connecting innovators with our industry experts to support their clinical goals and overcome FDA hurdles. Prior to joining the Proxima team, Keegan was an Independent Contractor, specializing in hardware installation for various builders throughout the Houston area. By utilizing his experience with customer interaction and lead generation in a detail-oriented field, he has been able to effectively translate his success in building a broader client base for Proxima. Keegan finds passion in supporting medical startups who continue to drive the field of medicine forward.
Christie Stephens is a Clinical Trial Assistant at Proxima Clinical Research, a partner for the emerging biotech and medical device industry. Over her career, Christie has served in a number of executive support roles. She recognizes the value of a dynamic team and the role that each team member plays in moving the mission forward.
Christie witnessed the power of a dynamic team firsthand when her father was diagnosed with Stage 4 Cancer in 2019. She recalls taking him to his appointments and meeting Rose. Rose was the last person he encountered after each chemotherapy session. She was in charge of scheduling his next appointments. Rose was efficient, empathetic, kind, funny, and confident with Christie’s father who, at times, was very emotional. Rose’s role on the team was understated yet powerful. When she did her job well, she set the team up for continued success. She had a lasting impact on both Christie and her dad.
Christie’s goal at Proxima is to bring more value to the team, doing her part to continue the forward progress and important work that has already been accomplished.
Brandon Clements currently serves as the Production Manager and Lead Producer of Podcasts at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Prior to joining Proxima, he served as a writer and content producer for major Houston publications including Houston Press, Houston Chronicle, and Byline Houston. At Byline Houston, he became the Editor and was responsible for leading a team of writers and coordinating content for daily release. Brandon has produced video content for a diverse set of clients including Volcom, a global skate apparel company, and Reality of Wrestling, Texas’ top independent wrestling promotion owned and operated by WWE Hall of Famer, Booker T.
Brandon has a deep passion for all aspects of video production, podcasting, and ultimately creating meaningful content that best fits the needs of the subject.
Sarah Gilbert is the Sr. Manager of Proposals, Budgets, & Contracts at Proxima Clinical Research, Inc., a contract research organization that serves the emerging biotech and medical device industries.
Sarah has over 6 years of experience completing complex RFP and RFI responses, which includes providing thoughtful client tailored proposals and complex budgets. Throughout her career, Sarah has been responsible for the development of corporate budget and proposal templates and tools, leading the negotiation and execution of client work orders and change orders, financial analysis, and study budget reconciliation.
Sarah graduated from Purdue University with a bachelor's degree in Business focusing on accounting. She is highly skilled in Excel and has developed many useful databases at previous companies. In her free time, Sarah enjoys travelling with her family and attending concerts and live sporting events.
Robert Yates currently serves as the Safety Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Robert has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives. Prior to joining the Proxima team, Robert was a Sr. Project Manager at the Clinical Research Organization MedSource. While at MedSource, Robert successfully provided oversight and managed one of the large pharma clients, which included a variety of studies over multiple indications. He has also held roles in managing projects for other clients as well. Over the years he has been involved in numerous clinical trials primarily in pharma and more recently with devices.
Mrs. Bertolini is the Associate Director of Clinical Monitoring at Proxima Clinical Research Organization (CRO), a partner for the emerging biotech and medical device industry. Mrs. Bertolini holds a B.S. in Health Administration and a M.S. in Public Administration, with a healthcare concentration, from the Eastern Michigan University. She is a certified trainer and a certified Clinical Research Associate (CRA).
Mrs. Bertolini has held a variety of positions within Clinical Operations. Formerly, she was a Clinical Operations Manager at IQVIA Biotech, leading up to twenty-five CRAs at a time, ranging from Senior level to inexperienced staff. During her time at IQVIA Biotech, she participated in the development and implementation of a CRA Academy, providing robust training and study placement for highly qualified individuals without previous monitoring experience. She has also served as a Senior Project Manager for eClinical Solutions, a Clinical Data Services Company, a Project Manager and Clinical Trials Manager for a mid-sized CRO. Mrs. Bertolini has participated in more than 30 clinical trials over twenty years.
Jennifer Horspool is Vice President of Communications for Proxima Clinical Research, bringing three decades of expertise as a global brand strategist, media maestro, public relations consultant, business growth expert, speaker, event planner, and social media maven. From start-ups to Fortune 500s, Jennifer employs her skills in PR, marketing, and media to grow companies from vision to multi-million dollars and turn best-kept-secret brands into the Go-To Experts™ for media and target customers.
Throughout her career, Jennifer has run the PR and marketing campaigns that brought dozens of drugs to market, working with big name brands such as US Oncology Research, McKesson Corp, Amgen, Daichii Sankyo, and Deloitte. As a brand-turn around specialist, Jennifer grew the US Oncology brand from unknown and unliked into the go-to resource garnering 500+ earned media articles year-over-year, including top tier media such as The Today Show, KNBC, Fox News, Forbes, Fortune, Wall Street Journal, New York Times, Medscape Today, MedPage, Modern Healthcare, and dozens of oncology trades; plus speaking engagements in industry conferences and meetings. She has refreshed old brands, launched new brands, and developed multi-cultural advertising and PR campaigns for Latino, Chinese, Vietnamese, Korean, African American, LGBT, among many other cultures and communities.
Jennifer received her Bachelor of Arts in Communications, with an emphasis in public relations and minor in health from Cal State University, Fullerton. In 2005, she became a certified business coach, and in 2016 she joined the speaker circuit entertaining and educating crowds as large as 2500 from more than 71 countries. She is the current President of the American Marketing Association Orange County Chapter and a former Board leader of Public Relations Society of America, Orange County.
Julian Lara is a music journalist and podcaster currently serving as a Videographer at Proxima Clinical Research, Inc., a contract research organization that assists the early-stage pharmaceutical, medical device, and biotechnology startups in all aspects.
In 2015, Julian pursued a career in media and committed his efforts to his podcast project, Dead Dialect, which was awarded Best Podcast 2017 by The Houston Press. With Dead Dialect, Julian enhanced his skills in videography and production by creating content focused on interviewing locally and nationally recognized names within the realms of music, comedy, and mixed martial arts. Julian also contributed articles and web content for Byline Houston, LLC., a Houston publication covering music and culture. At Proxima, Julian’s responsibilities are to film, edit, and produce various video projects created by the Proxima Marketing & Communications team. Otherwise, Julian spends time enjoying other passions such as performing in comedy wrestling, creative writing, and more recently, studying the Japanese language.
Dr. MacCuspie currently serves as a Regulatory Affairs Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Rob served as the VP of Science at a rolled goods materials science startup, leading their entrance to the medical device space by helping identify regulatory strategies and leading building their first quality management systems, and as Director of Science at a leading dietary supplement company, where he contributed to the company’s first medical device product development regulatory and testing strategies and developed and delivered product education for practitioners and consumers. Rob has previously been the First Faculty and Director of Nanotechnology and Multifunctional Materials programs on the startup team at Florida Polytechnic University, founded a consulting company to help scientific startups accelerate their path to market, and worked in the national lab system including at the National Institutes of Standards and Technology, contributing with the Nanotechnology Characterization Lab collaboration between NIST, NCI, and FDA to develop standards and methods to accelerate cancer nanomedicines from bench to bedside.
Dr. MacCuspie earned his Ph.D. in Nanotechnology and Materials Chemistry from The Graduate Center of the City University of New York, a Bachelor’s of Science in Chemistry and a Bachelor’s of Science in Molecular Biology and Microbiology from the University of Central Florida. He has published 45 peer-reviewed publications which have been cited over 3,400 times and holds 1 US Patent. Rob has also written and presented content for multiple scientific companies to help with their product education and technical sales efforts, and has been on dozens of product launch teams.
Grace Carrell, MMB, MBA is a Regulatory Affairs Associate at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. Prior to joining the Proxima team, Grace completed a dual master’s degree at North Carolina State University. She has a Professional Science Masters in Microbial Biotechnology and an MBA. During her graduate studies, she focused heavily on the commercialization of new technologies. Working as a graduate consultant for a large range of companies, she has experience with small startups and multi-national corporations. Grace has a deep understanding and respect for the challenges associated with entrepreneurial endeavors and the impact innovation has on the healthcare field.
Alan Cooper is a Design Controls & Engineering Consultant at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. Alan spent 8 years designing & testing production active sonar systems for the U.S. Navy. He holds a B.S. in Electrical Engineering from A&M & a M.S. in EE - Electromagnetics/Acoustics from the University of Texas. Since 2015, Alan has worked for a small medical device design firm implementing design controls, writing specifications and verification procedures, designing and testing circuitry and software algorithms, and managing standards compliance testing.
Reepal Babariya is an Associate Clinical Data Manager at Proxima Clinical Research, Inc. She has previously worked as a Associate Clinical Data Manager at Clinical Trial Services B.V., Netherlands. Reepal has worked with Medrio EDC system.
Throughout her 2+ year experience in Data Management, Reepal worked in all aspects of Data Management starting from assisting in Query Management. She assisted in Clinical Data Management function, participating in the review of Clinical Research documents (e.g., Protocols, Case Report Forms, Reports and Statistical Analysis Plans.). She also supported the development of clinical trial data specifications, including eCRF design, User Requirements, validation checks and query logic, and User Acceptance Test (UAT).
Haley is a Clinical Trial Assistant at Proxima Clinical Research, a company that contributes to the biotech and medical device industry. Haley has over two years of experience in clinical research. Haley previously worked as a clinical research coordinator at a diabetes and endocrinology practice that focused on conducting phase II-III drug and device clinical trials related to type 1 diabetes, type 2 diabetes, obesity, and cardiovascular disease. Haley received a B.S. in Nutritional Sciences from Texas A&M University of College Station.
Michelle Wawrzyniak currently serves as a Clinical Research Associate at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
She began her career in social services, working closely with non-profits to provide support to the indigent populations of Detroit, Michigan. She spent several years in real estate, as a commercial real estate broker and as a property manager, in North Carolina. While pursuing a career in clinical research, Michelle gained a range of experience and has a robust perspective on how studies are managed from start to finish. She has experience in managing day-to-day activities, training staff, database & eTMF management, and administering sponsor and FDA audits.
Over the last few years, Michelle has focused on clinical monitoring, starting as a Clinical Trial Associate. As a Clinical Research Associate at Proxima, she supports the clinical monitoring team across several studies. Michelle continues to support the clinical team with training, process development, and metrics for management.
Ms. Wawrzyniak received a B.A. in Psychology, with honors, from Michigan State University. She has been involved in several clinical trials for pharmaceutical and medical device companies pursuing marketing indications and been involved in regulatory submissions for pharmaceutical companies.
Daniela is a Clinical Trial Assistant at Proxima Clinical Research, a company that contributes to the biotech and medical device industry. Daniela has previously worked as a clinical research coordinator in an infectious diseases research institute, focusing on conducting phase II-III drug and observational clinical trials related to COVID-19 and HIV. Daniela also has experience in laboratory coordination and management. She is originally from Venezuela and received a B.S. as Medical Technologist from University of Carabobo, and a M.S. in Basic Immunology from Central University of Venezuela.
Sondra Simpson currently serves as a Clinical Project Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Sondra has 11 years of clinical research experience working from the site, CRO, and sponsor perspectives. Prior to joining the Proxima team, Sondra was a Project Manager at the CRO MedSource. While at MedSource, Sondra specialized in working with small biotech companies to help deliver several long term neurological studies. In addition, Sondra supported global studies through the study start up phase.
Melissa Miller is a Sr. Clinical Data Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. She previously worked as a Data Manager at a biopharmaceutical company and a Research Database Specialist in HEOR. Melissa has worked with many different EDC systems including, OpenClinica, Medrio, ClinCapture, and iMedNet.
Throughout her 8+ years of experience in Data Management, Melissa has worked in all aspects of Data Management starting from writing Data Management Plans. She has ample experience in developing, building, maintaining, and closing EDC systems for Phase 1-3 studies which includes designing case report forms, programming and testing edit checks, training users, and closing-out studies.
In addition to experience in Data Management, Melissa has also worked in computer system validation for EDC systems, eTMF systems, and electronic signatures. She has also gained experience in SAS programming with both statistical analyses and data manipulation.
Sean Bittner is currently the Director of Programs for new ventures at Proxima Clinical Research, Inc., a contract research organization that assists early-stage pharmaceutical, medical device, and biotechnology startups in all aspects. Prior to joining Proxima, Sean was a graduate research fellow at Rice University, where he studied applying 3D printing to tissue engineering of bone and cartilage. While in graduate school, Sean developed a passion for personal and professional development, particularly leadership development. He completed over 200 hours of training in coaching skills and interpersonal dynamics and was recently credentialed as an Associate Certified Coach with the International Coaching Federation. Using the skills developed during his leadership training, Sean went on to manage three graduate student teams to design experiments for his PhD work, and two short-term consulting projects with life science companies in Houston. As the Director of Programs for new ventures at Proxima, Sean is excited to support the development of life science startups from idea to market.
Laura Wilson currently serves as the Clinical Business Development Strategist for Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging drug & medical device companies in clinical product development. Laura has 11 years of sales, business development, and account management experience. Over the past 5 years, Laura has worked in the research & biotechnology space across the Southeastern U.S. and is thrilled to bring that experience to Proxima to continue supporting innovators on their startup journey. Laura has a passion for creating strategic connections & partnerships to support all innovators within the space. Prior to joining Proxima, Laura served as a Regional Account Executive for Medix, a National Healthcare & Scientific recruiting & staffing company. In this role, she managed the Southeast territory, working with Clinical Research & biotechnology companies to support them with their hiring strategies.
Amrutha Raja currently serves as a Quality and Regulatory Affairs Associate II at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Amrutha served in the Quality and Regulatory Affairs departments as a Regulatory Affairs Associate for a medical device company where she was charged with authoring SOPs, QOPs, taking part in Internal Audits, reviewing Change Orders, and approving design documentation as the Quality and Regulatory representative on multiple projects.
Bhavik Patel currently serves as the Quality and Regulatory Associate II at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Bhavik served as the QA/QC Manager for a medical device company where he was charged with developing and maintaining the Quality Management System. He played a key role in the organization in getting ISO 13485:2016 certification for the company.
Bhavik has also served as Materials Engineer II at a medical device startup company which was a spinoff from UT Health System. Bhavik contributed to the research and development, prototype manufacturing, FDA submission and clinical trials for the device.
Carla Motteler is a Clinical Trial Assistant at Proxima Clinical Research, Inc., a contract research organization that serves the emerging drug and medical device industries. Carla has over 20 years of teaching experience, both as a virtual instructor and instructional designer. Prior to joining the Proxima team, Carla was a virtual instructor with a large Edtech company, where she designed, developed and deployed instructional materials and deliverables.
Carla successfully designed and presented professional development sessions for staff and created and implemented initiative projects to increase student success. Carla graduated from The University of North Carolina at Chapel Hill with bachelor's degrees in Spanish and Education, and a Master of Education.
Carla plans to keep the patient suffering from disease at the forefront of her mind as she utilizes her background in managing multiple large scale educational projects simultaneously. Having witnessed several family members suffer from cancer and disease, she hopes to play an integral part in the advancement of science with precise data management and excellent customer service.
Emily Goodin is a clinical data manager at Proxima Clinical Research, Inc., a contract research organization that serves the emerging drug and medical device industries. Emily has over seven years of clinical data management experience. Prior to joining the Proxima team, Emily was a clinical data manager at LSU’s Pennington Biomedical Research Center. While at Pennington, she successfully managed data for numerous phase I-IV trials.
During her seven years as a clinical data manager, Emily gained experience in case report form creation, database security and testing, data cleaning, user training, as well as learning and adhering to all regulatory standards.
In addition to her data management experience, Emily has also worked in editorial roles and as a search engine optimization analyst.
Kyle Dexter is a Clinical Research Associate for Proxima Clinical Research, a partner for the emerging biotech and medical device industry. Over his career, Kyle has served in many different roles within the clinical research space. He served as a clinical research coordinator at two major hospitals in the Cleveland, Ohio area (Cleveland Clinic and University Hospitals Cleveland Medical Center). During his time at these institutions, he was involved in coordinating clinical trials in the Neurological Institute and Cardiovascular and Vascular Institute. During this time, Kyle also served as the Clinical Regulatory coordinator for the wide scope of trials being conducted in the Cardiovascular and Vascular Institute. Following Kyle’s site level involvement, he served as a Clinical Field Specialist and Clinical Research Coordinator for TriReme Medical. During his time there, he was responsible for device training, device use support, clinical trial support and clinical monitoring. He continued to work in the clinical trial sponsor space for SPR Therapeutics as a Clinical Research Associate, where he provided clinical trial support for two peripheral nerve stimulator trials. Most recently, Kyle has served as a Clinical Research Associate for IQVIA MedTech providing clinical trial support and clinical monitoring for a wide range of clinical trials.
Kyle received his B.S in Neuroscience from Ohio Northern University where he also served as a Research Assistant under Dr. Philip Zoladz. He has been published in two peer reviewed articles and presented two posters at the 42nd Annual meeting of the Society for Neuroscience in 2012. The research lab focused on using animal models to investigate the potential correlation between memory loss and stress/PTSD; as well as the correlation between corticosterone response and memory impairment.
Michelle Lewis is a Regulatory Affairs Consultant at Proxima Clinical Research, a contract research organization that serves the emerging drug and medical device industries. At Proxima, she will work on various medical device and drug product consulting projects and submissions across all stages of development. Prior to joining the Proxima team, Michelle served as the Director of Accreditation at the premier standard setting body, non-profit, scientific, and educational organization, where she managed the accreditation program. She has also served in additional quality, regulatory affairs, and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications.
She has been an active regulatory and quality systems auditor for more than 20 years working in a variety of industries including biologics, drugs, medical devices, and HCT/P’s as a supplier auditor, internal auditor, and consultant. Michelle has written content and managed complex quality and regulatory systems for multiple companies through her more than 20 years in industry.
After finishing a BA in Psychology, Michelle's direct industry expertise began while working for Baxter International as a Quality Management Representative in the BioScience division. Through her time at Baxter, Synthes USA, AlloSource, and AATB she gained a wealth of 1st, 2nd, and 3rd party regulatory and quality experience.
Rebecca Moore has over four years of CRO operations work experience and is currently the Controller at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. While obtaining her Bachelor’s degree in Psychology with a minor in business from Sam Houston State University, Rebecca worked part-time as a bookkeeper, court reporter assistant and bank teller. After graduation, Rebecca went to work at her family’s accounting firm to further her career and develop her leadership skills. She provided full charge bookkeeping services for over sixty small businesses which included restaurants, gas stations, hair salons, lawyers, doctors and more. She quickly exceled and became Office manager of a staff of ten bookkeepers. Rebecca has always had a thirst for knowledge and began taking additional accounting courses to sit for the CPA exam. Her lifelong goal is to become a CPA and she is actively studying in her free time.
Rebecca is detailed oriented and has provided process improvement solutions for many businesses. She has streamlined accounting processes and expedited management reporting deadlines. Her efforts have provided management teams financial data that led to growth and increased profitability. She excels in data cleaning, financial statement analysis, QuickBooks training and guiding accounting procedures and policies for start-up companies to manage all aspects of their business. Rebecca’s overall goal is to help businesses grow and thrive by ensuring accurate and timely financial data.
Samantha Pickett is the Manager of Study Start-Up at Proxima Clinical Research, Inc., a contract research organization that serves the emerging drug and medical device industries. Samantha has over 6 years of clinical research experience ranging from single site Phase I studies to large multi-site Phase III oncology, device, and rare disease studies. Prior to joining the Proxima team, Samantha was the Manager of Clinical Support Services and a Study Start-Up Specialist at Ergomed (previously MedSource) and an In-House CRA and a CTA at LabCorp Drug Development (previously Chiltern). While at Ergomed, Samantha played a key role in updating SOPs and globalizing company responsibilities and procedures. She successfully navigated multiple studies through the start-up phase and oversaw the implementation of TMF review processes. During her time at LabCorp Drug Development, Samantha worked directly with sites to implement specific recruitment strategies and ensure timely query resolution as well as working hand in hand with project managers to ensure day to day activities ran smoothly. Samantha graduated from the University of North Carolina – Wilmington with a Bachelor of Science degree in marine biology.
Travia Belton currently serves as QA Associate II at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. She has worked in GCP, GCLP and CLIA regulated laboratories where she where she was charged with quality management and QA Oversight in lab operations.
Larry Lawson is a Founder and Executive Chairman at Proxima. He has 45+ years of experience in the healthcare industry.
He has been the founder, board member, and executive at several medical device companies: eCardio Diagnostics, Decisio Health, HeartcoR Solutions, and Preventice. He is an Angel Investor with the Goose Society, TMC Venture Fund, and Angel MD.
He is a Distinguished American Award recipient from the Horatio Alger Association.
Kevin Coker is the Co-Founder and CEO of Proxima Clinical Research a partner for the emerging biotech and medical device industry. Over his career, Mr. Coker has served in a number of executive roles. Previously, he was CEO and Director of MolecularMatch, a software company dedicated to helping laboratories interpret next generation sequencing tests for clinical practice. He served as the Vice President and Oncology Franchise Lead for Worldwide Clinical Trials, a global CRO working in over 50 countries, and the Vice President of Research for McKesson/US Oncology. Mr. Coker is currently a Board Director for Volumetric, a 3D bioprinting company focused on making the world’s first 3D printed liver and is an advisor for Bioverge, an investment platform focused on life science companies.
Mr. Coker received a B.S. in Biology from the University of Central Arkansas, a M.S. in Pathology from the University of Arkansas for Medical Sciences, and J.D. and M.P.H. degrees from Case Western Reserve University. He is as a certified clinical molecular biologist CLSp(MB) and Regulatory Affairs certified RAC (US). He is the former Chair of the Ethics Committee for Regulatory Affairs Professional Society (RAPS) as well as past Board Member and served as an Assistant Attorney General for the State of Arkansas. He has been involved in over hundred clinical trials for pharmaceutical companies pursuing marketing indications and been involved in dozens of regulatory submissions for both biotech and medical device companies.
Matthew Wagener currently serves as the Vice President of Clinical Operations at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Matt has over 15 years of industry experience working across multiple life science businesses in key areas including clinical operations, business operations, and business development.
Prior to joining the Proxima team, he was a member of the executive team and the Sr. Director of Corporate Operations at MedSource, a CRO focused on Oncology, Neurology, and Rare Diseases. While at MedSource, Matt successfully managed corporate operations and business development through high growth period (57% CAGR over five years) building operations to support growth. Prior to MedSource, he held several management positions at McKesson Specialty Health / US Oncology. At US Oncology Matt led clinical and business operations for the launch of their oncology CRO through start-up, full service clinical trial operations, and business acquisition. Prior to managing the CRO business unit at US Oncology, he led clinical development for the Lung, GI, Hematology, and Radiation Oncology research programs. He also held other research positions at the University of Texas Medical Branch in Galveston in the department of Orthopedic Surgery and MD Anderson Cancer Center in the department of Radiation Oncology.
Matt received his degree in biomedical science from Texas A&M University. Since starting his career in research, he has worked in key sections of basic and clinical research from bench to bedside to management.
Isabella currently serves as the Director of Regulatory Affairs at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. Prior to joining the Proxima team, Isabella served as the Senior Regulatory and Quality Manager for a medical device company where she was charged with outlining the regulatory strategy and putting together design controls and design history documentation, and as the Director of CMC and Quality at a biopharmaceutical company, where she oversaw all manufacturing and analytical processes and timelines and ensured CMC regulatory strategy was sufficient for filings in Europe and the US.
Ms. Schmitt has also served in additional regulatory affairs and clinical research roles in which she contributed to multiple regulatory submissions and clinical affairs projects across a wide range of indications. Isabella is a judge and mentor for MedTech Innovator, and in her spare time, she serves as a TMCx advisor and speaker, helping companies with regulatory affairs, quality, and clinical development questions, and as a MassChallenge Houston judge and mentor. She also serves as a pitch coach for SXSW Pitch Competition.
Stephanie Mull currently serves as the Director of Project Management at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Stephanie has over 20 years of clinical research experience working from the site, CRO, and sponsor perspectives. Prior to joining the Proxima team, Stephanie was Sr. Project Manager at the CRO MedSource, the Strategic Alliance Manager at McKesson/US Oncology, and the GU/GYN Program Manager at US Oncology. While at MedSource, Stephanie successfully led a global team to completion of a phase III trial for subjects with super refractory status epilepticus, and served in a consultancy role for a CNS biopharmaceutical company, supporting the management of a suite of MDD trials. During her time at US Oncology she developed, secured, and managed strategic partnerships with multiple large pharmaceutical companies and led the GU/GYN operations program, overseeing and directing a team of project and data managers. She has also held roles managing multiple oncology, cardiology and allergy & asthma trials. Stephanie received a Natural Science (biology/math) degree from Concordia University in St. Paul, MN.
Chenett Greer currently serves as a Clinical Project Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
She has worked in clinical research for over 18 years. Chenett began her career as a clinical research specialist where she screened, recruited, and handled the consent of clinic patients across various registries & PI initiated studies. She also worked as a Clinical Research Coordinator at Cleveland Clinic, coordinating Phase II-IV Respiratory clinical trials. Chenett has ten years of experience working as a Project Manager. Her experience includes managing the implementation of 21 part 11 compliant electronic data capture systems, and managing the daily operations of a research center where she trained & oversaw study personnel and managed the study startup process. Recently, she executed Phase II and III medical device trials in Neurology, Respiratory, Cardiovascular, and Imaging.
Alisa Hamilton has many years of CRO operations work experience and is currently the Manager of Operations, Marketing, & Communications at Proxima Clinical Research, Inc. Proxima is a contract research organization focusing on assisting emerging pharmaceutical and medical device companies in clinical product development. While obtaining her Bachelor’s degree in General Business from Stephen F. Austin State University, Alisa started performing the role of a leader, by becoming team captain for the University’s Division-I softball program, where she was a 4-year letterman scholarship-athlete. After graduation, Alisa took the leadership skills she developed on the field to the professional world at Baylor Scott & White, where she was responsible for training new hires as an Epic super user, Accounts Receivable and Accounts Payable, coordinating office meetings and special events. Alisa has always been driven by finding solutions to the simplest and complex tasks.
Through Proxima’s start-up phase, Alisa identified the need for a leader that would conquer perplexing procedures, and she knew she was the best fit for the challenge. Over the last few years at Proxima, Alisa has successfully implemented new onboarding/exiting procedures, HR Policy’s, project management systems, and IT solutions while managing invoicing, marketing, social media, content planning/development, client/vendor proposals and contracts, insurance policies, client relationships, employee acknowledgment, and company mural. Alisa’s overall goal through everything she has achieved at Proxima is to make it one of the most enjoyable places to work.
Liz Abide currently serves as the Marketing Manager at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Prior to joining the Proxima team, Liz was a Digital Marketing Account Manager for Wpromote, a national digital marketing agency. She grew her client's presence through innovative and strategic solutions. With her experience in local/national SEO, blog writing, Facebook/Instagram ads, Google Ads, Bing Ads, and Programmatic experience, Liz has pushed growth-focused digital strategies for small-to-medium business leaders.
Liz is fascinated with learning UX design, emerging company strategies, and analytics. Her goal is to learn and consistently develop a creative, sustainable marketing strategy focused on maintaining a relationship that is communicated with valued customers.
