We recognize that employees look and feel different in every company, so it’s important to first describe the principles that will drive success in the role prior to talking about the specific responsibilities and tasks. These are: 1. An obsessive focus on the customer 2. Being accountable to the customer as if we were their own employee 3. Understanding that strategy is only as good as the execution - and vice versa 4. Placing a high value on teamwork 5. People are at the heart of the product
In short, we want to build a big but small company.
PERKS: Amazing culture: Happy, Helpful, Humble, Hungry. Get to work in one of the fastest growing industries in TX – Life Sciences Part of an amazing team Flexible time off with pay Opportunity for growth!
We know that diversity makes for the best problem-solving and creative thinking. We are dedicated to adding new perspectives to the team and encourage everyone to apply if your experience is close to what we are looking for.
EqualOpportunityEmployer: Proxima is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
As the Senior Clinical Research Associate, you will be responsible for all aspects of the start up, implementation and management of clinical trials to assure compliance with applicable regulatory requirements and Good Clinical Practices (GCPs).
A Day In the life
Oversight of Clinical Research Associates
Preparation of protocols and other site materials
Identification of investigators
Overnight travel 30%-80%, anywhere in the U.S.
Training and initiation of clinical sites
Study planning, management and troubleshooting, ensuring proper escalation of site issues
On-site monitoring of clinical studies
Validation, collection and management of study data
Ensuring study metrics are tracked and communicated as appropriate
Managing enrollment issues, resolution of data queries and site performance issues
Audit, manage and collect clinical regulatory documents
Ensure site compliance with regulatory requirements and Good Clinical Practices (GCPs), and Proxima and client policies and procedures
Prepare clinical sites for FDA audits
Manage accountability of investigational product and documentation
Conduct study site close-out visits
Assisting with other projects within the company, such as assistance with preparation of FDA submissions and regulatory research
Attendance at company meetings, completion and proper submission of timesheets and documentation of training
Adherence to Proxima or client Standard Operating Procedures (as applicable)
Professionally represent Proxima in business interactions
Must Have Knowledge and Skills
Must have strong interpersonal skills.
Excellent oral and written communication skills.
Ability to articulate issues.
Self-management skills, including ability to multi-task.
Attention to detail and accuracy in work.
Strong problem solving and interpersonal skills.
Keyboarding, word processing, and computer skills (proficiency using Microsoft Office).
Ability to maintain confidentiality.
Nice to Have Knowledge and Skills
BA, BS or Associate’s degree or equivalent in a scientific or healthcare field with a minimum of 2 years on-site monitoring experience.
Must have thorough understanding of current GCPs and FDA regulations pertaining to clinical research.
Familiarity with common medical terminology is required.