Clinical Trial Associate

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