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.
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.
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.
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 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.
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.
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.
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.
Vinson Pagan currently serves as a Clinical Research 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 Proxima, Vinson was a Clinical Research Associate with SGS- Life Sciences and Lampgen Clinical Research. He is a member of the Association of Clinical Research Professionals. Prior to his career as a Clinical Research Associate, he held roles as a study coordinator, pharmacy technician, and nutritional consultant.
Mr. Pagan received a B.S. in Biology from Morehouse College in Atlanta, GA.
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.
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.
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.
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.
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.
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.
Madel Fonlon 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.
Madel has over 10 years of clinical research experience ranging from site level, to CRO, and sponsor. Prior to joining the Proxima team, Madel was a study Manager at AstraZeneca and managed multiple studies in oncology and respiratory, while providing support and training CRAs in study related matters. Madel graduated from the University of Texas at Dallas with a degree in Neuroscience and has a Master’s from Drexel University in Clinical Research Organization and Management.
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.
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.
Deepthi Paknikar 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.
Upon graduating dental school, Deepthi started working as a general dentist and has experience in the private and public healthcare sector. She also served as adjunct faculty at a Dental Hygiene Program. Deepthi’s previous experience at the University of Michigan included leading research projects and engaging in scientific writing and presentations.
Abdul Choudhry currently serves as Content Writer at Proxima Clinical Research. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development.
Prior to coming to Proxima, Abdul worked in Education and as a freelance writer. Fueled by his passion for innovation in Technology and Medicine, Abdul enjoys taking dense and complex information and making it accessible to a widespread audience.
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.
Ms. Neha is the Safety Associate for Proxima Clinical Research, a partner for the emerging biotech and medical device industry. She has over 6 years of experience working for both Sponsor as well as CRO perspectives. Prior to joining the Proxima team, Neha was an Operational Specialist at the CRO IQVIA. While at IQVIA, Neha successfully provided oversight and managed a small team. Throughout her career, she has been involved in numerous clinical trials and post marketing studies primarily in pharma.
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.
Lyndsey Schroder is a Clinical Trial Assistant at Proxima 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, she worked as a Clinical Research Coordinator for the University of Cincinnati Department of Neurology, where she helped conduct clinical trials and investigator-initiated research in Multiple Sclerosis, Parkinson’s Disease, Dementia, Alzheimer’s Disease, Migraine, and Cervical Dystonia.
Lyndsey graduated Cum Laude from the University of Cincinnati in 2018 with a Bachelor of Science in Neuroscience.
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.
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.
Grace Carrell, BS, 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.
Catherine Le 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.
Prior to joining the Proxima team, Catherine served as the lead research technician at UCLA Health, where she managed the execution and data generation of several clinical trials. She also served in additional clinical research roles, where she contributed to publications incorporating next-generation sequencing into standard of care testing.
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.
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.
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.
Stephen Gruschkus is a Senior Biostatistician at Proxima Clinical Research, Inc., a contract research organization that serves the emerging pharmaceutical and medical device industries. Stephen has over 15 years of biostatistics, clinical epidemiology, and outcomes research experience across multiple disease areas. Prior to joining the Proxima team, Stephen was a Research Biostatistician at MD Anderson Cancer Center where he was responsible for clinical trial design and provided Biostatistics support to several clinical departments. He has co-authored over 20 scientific manuscripts and has been involved in the American Society of Clinical Oncology (ASCO) and the Professional Society for Health Economics and Outcomes Research (ISPOR).
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).
Victoria Boss-Oderinde current 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.
Victoria has over 3 years of clinical research experience working from the site perspective. She has managed and coordinated clinical trials across different research areas, including hematology oncology, cardiology, and medical devices. Prior to joining the Proxima team, Victoria was a Clinical Research Coordinator II at Emory University School of Medicine, Clinical Research Coordinator at Northside Hospital, and a Research Coordinator at Emory University Winship. While at Winship, Victoria successfully consented over 1000 patients for a bio-banking study.
Victoria graduated from Mercer University in Atlanta, GA with a Masters degree in Public Health.
Liz Martin 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. Liz is responsible for leading and coordinating cross-functional project teams and executing clinical projects.
She manages clinical studies to ensure timelines are met, on-budget, and have adequate human resource allocations. Liz reviews and approves client deliverables and project work prior to client submission.
Taylor Lunsford 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.
Stephanie Allan currently serves a Clinical Scientist at Proxima Clinical Research, Inc. Proxima is a contract research organization focused on assisting emerging pharmaceutical and medical device companies in clinical product development. In her role, Stephanie helps write and design clinical trials in line with the current phase of product development and regulatory strategy.
Previously, she has helped write and design investigator-sponsored trials at Huntsman Cancer Institute in Salt Lake City, Utah. There she gained extensive oncology experience in solid tumors and hematological malignancies and dyscrasias. Her prior clinical research experience includes trial management, clinical development, and medical writing.
Stephanie earned a Bachelor of Science in Biology with a minor in Chemistry from the University of Utah. She went on to receive her Master of Science in Clinical Pharmacology with an emphasis in Clinical Trial Design from The Ohio State University. She is a Certified Clinical Research Coordinator through the Association of Clinical Research Professionals. Over the course of her carrier, she has developed a working knowledge of FDA regulations, OHRP, ICH, ethical guidelines, clinical trial conduct, and study design.
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.
Gissell Montoya currently serves as a Clinical Data 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, Gissell worked at the University of Texas MD Anderson Cancer Center where she served as a Research Data Coordinator, helping coordinate programs for cancer survivors and helping at risk individuals lose weight using e-health digital devices.
Gissell has research experience in diabetes prevention, e-health digital devices, cancer prevention, survivorship, telehealth, and medical tourism.
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.
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.
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.
Jeanelle Lopez currently serves as the Regulatory Project Coordinator 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, 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. Jeanelle dedicated her attention to process analysis for improvements on delivery time. Jeanelle held the role of Document Control Lead, where she was responsive for overseeing project progress to ensure division goals were met while governing the preparation, maintenance, and quality control of documents.
Jeanelle Lopez has a Masters 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. In her spare time, she volunteers for the American Heart Association helping communities with fundraisers.
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.
Dr. Ken Fujiwara 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. He has contributed to a wide range of regulatory and clinical projects for clients in both the medical device and pharmaceutical drug fields, including Breakthrough Device Designation applications, Pre-Submission Meeting requests, 510K submissions, CE Mark applications, Clinical Trial protocols and IND submissions.
Dr. Fujiwara regularly provides QC and document review for the entire regulatory team and also handles drug and medical device submissions to the FDA.
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.
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.
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.
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.
Aryan Abedi currently serves as a Quality Assurance and 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, Aryan worked as a Quality Control Intern for Radiomedix where he was responsible for the creation and execution of technical and quality procedures, validation of incoming equipment, and execution of quality testing such as Gamma-ray spec and ICMPS to ensure batch integrity and standards.
Aryan has a B.S. in Biomedical Engineering with a focus in biomaterials and tissue engineering from Texas A&M University. He has worked on the development of surgical medical devices from need identification through the entire development process.
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.
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.
Jenna is a Clinical Research Associate (CRA) at Proxima Clinical Research, Inc. She began monitoring clinical trials in 2015 and has enjoyed the opportunity to work as a CRA for a biopharmaceutical company as well as Contract Research Organizations (CROs). Jenna strives to foster positive working relationships with research sites to ensure smooth study conduct. She has experience in monitoring both pharmaceutical and medical device studies in multiple therapeutic areas including oncology, neurology, endocrinology, gynecology, and infectious disease.
Jenna has a B.S. in Biology from North Park University, Illinois and has completed a postgraduate certificate program in Microbiology at James Cook University in Townsville, Australia.
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.
