The Senior 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, field-based position and reports to the Clinical Trial Manager.
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
- 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
Novocure is taking a responsible approach to creating environments that allow us to strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
As part of our commitment to health and safety, COVID-19 vaccines are required for our current U.S. employees. As an Equal Opportunity Employer it is our policy to provide reasonable accommodations to any qualified individual, who, because of a medical condition, or sincerely held religious belief/practice, receives an exemption from the vaccination requirement, if such accommodation would not result in an undue hardship for the company.
For more information regarding the Novocure’s COVID-19 vaccination requirement, exemptions, and verification of vaccination status please ask the Talent Acquisition Team.
Patient-forward: aspiring to make a difference in cancer.
Our patient-forward mission
Together with our patients, we strive to extend survival in some of the most aggressive forms of cancer by developing and commercializing our innovative therapy.
Our patient-forward values
Nearest Major Market: Boston