Clinical Project Associate
RemoteUnited States
Job Summary
Facilitate the successful conduct of clinical investigations by performing on-site and remote monitoring visits, maintaining in-house study files, and supporting study initiation, enrollment, and closure. Ensure site compliance with FDA regulations, ICH/GCP guidelines, and OrganOx policies through protocol reviews, IRB submissions, and data accuracy checks. Create queries and action items to resolve discrepancies, provide training to site personnel, and interface with investigators, coordinators, and field staff. Complete Monitoring Visit Reports and follow-up letters while identifying and reporting serious compliance issues to management. Work remotely across multiple time zones with 10% travel for meetings and training, adhering to departmental SOPs and assisting with audits and continuous quality improvement projects.
Required Qualifications
- Bachelor's or Graduate degree in a life science, nursing or other health related disciplines
- Must have a valid US driver's license
- 2 years clinical research experience in medical device or pharmaceutical industry or CRO as a CRA, clinical trial assistant, research site role or similar role
- Strong working knowledge, understanding and ability to apply FDA regulations and ICH/GCP guidelines governing clinical trials
- Ability to travel 10% of the time for training, investigator meetings, monitoring responsibilities, corporate meetings, and educational seminars
Desired Qualifications
- Preferred demonstrated aptitude and knowledge in relevant therapeutic area (Transplant Surgery and/or medical device research) and ability to learn and integrate new or different therapeutic areas
- Current certification as a Certified Clinical Research Associate (CCRA) or current Certified Clinical Research Professional (CCRP) is preferred
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