CLINICAL TRIAL ASSOCIATE
JOB SUMMARY:
The Clinical Trial Associate supports the Clinical Trial Manager and Study Team with all operational and trial related activities from study start-up to close out.
This is a full-time, exempt (salaried), field-based (remote) position and reports to the Clinical Trial Manager. Preference for candidates in the Eastern Standard Time zone, with oncology experience.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Set up trial meetings, meeting minutes, manages rosters
- Support for documents creation, review, and feedback coordination
- Quality control of TMF, CTMS
- Collate and track information and timelines (feasibility, CDA)
- Support TMF review and tracking of CRO
- Tracking of study tools – internal Novocure trackers and CRO trackers
- Manage study-related supplies and study-related material requests
- Manage Compliance reports
- May support coordination of document translation management
- Participate in projects for the overall clinical operations team
QUALIFICATIONS/KNOWLEDGE:
- Bachelor's degree or equivalent; preferably in Nursing, Medicine, or other Life Sciences. Or RN degree from an accredited school or equivalent work experience required
- Minimum of 1-year Clinical Trial experience in various Clinical Trial activities from initiation to closure. On-site monitoring preferred (both CRO and industry experience are acceptable)
- Detailed knowledge of Clinical Trial Process, including ICH/GCP guidelines
- Experience in identifying potential deficiencies in the trial progress and assisting in/suggesting corrective and preventive actions (CAPA)
- Experience in TMF set-up, maintenance, and periodic reviews
- Experience in review and tracking of regulatory documentation for successful implementation of Clinical Trials
- Experience as CRA (working for CRO or sponsor company) would be an advantage
- Familiarity with clinical research, Oncology a plus
- Familiarity with Medical Device regulations, Clinical Trials, and ISO
OTHER:
- Fluency in English
- Ability to lift up to 20 pounds