Job Description
This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. This is a unique opportunity for candidates with a background in cognitive assessment or nutrition research to contribute to meaningful work in obesity-related studies. Ideal applicants will have hands-on experience administering cognitive batteries or 24-hour dietary intake interviews, and familiarity with tools like NDSR or mobile-based cognitive testing is a plus. The selected candidate will work directly with participants seeking to lose weight and play an active role in data collection and publication efforts-an excellent foundation for future careers in research or clinical health fields.
The Clinical Research Associate I works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies. Supports objectives of research studies through noncomplex tasks such as data collection, prescreening of potential and scheduling of current research participants, assisting in IRB submission activities, budget and billing, and ensuring overall compliance with all federal and local guidelines.
Primary Duties and Responsibilities - Works under the direction of a Clinical Research Coordinator, Research Program Administrator, Research Nurse, or other supervising staff to assist in tasks supporting the coordination/implementation of noncomplex research studies.
- Collects, evaluates and/or abstracts clinical research data. May assist in designing forms for data collection/abstraction. Enters and processes clinical research data into Electronic Data Systems (EDCs) that are provided by the sponsors.
- Completes Case Report Forms (CRFs).
- Assists with prescreening of potential research participants for various clinical trials. Schedules research participants for research visits and research procedures. Provides supervised patient contact or independent patient contact for long term follow-up patients only.
- Assists supervising staff with regulatory submissions to the Institutional Review Board (IRB) including submission of Adverse Events, Serious Adverse Events, and Safety Letters in accordance with local and federal guidelines.
- Assists with clinical trial budgets and patient research billing.
- Responsible for sample preparation and shipping and maintenance of study supplies and kits.
- Ensures compliance with protocol and overall clinical research objectives. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- May serve as one point of contact for external sponsors for select trials. May respond to sponsor inquiries and attend meetings regarding study activity under the direction of supervising staff.
Qualifications This role is designed to be 100% onsite, giving you the opportunity to collaborate closely with your team and immerse yourself in the energy of our workplace. Please note that hybrid or remote work options are NOT available for this position at this time. Required :
- High School Diploma/GED required.
Preferred Qualifications:
- Demonstrated proficiency in administering cognitive batteries or conducting 24-hour dietary intake interviews.
- Familiarity with nutrition-related tools and databases such as NDSR or mobile-based cognitive testing platforms is preferred.
- Prior experience working on obesity-related research studies.
- Strong interest in contributing to participant-centered research aimed at weight loss and health improvement.
- Opportunity to support data collection efforts that lead to scientific publications-ideal for candidates pursuing careers in research or clinical healthcare.
- Bachelor's Degree Science, Sociology or related degree.
- 1 year Clinical research related experience.
Job Tags
Full time, Local area, Remote job,