Title: Clinical Trial Lead Location: Boston, MA.
Start Date: ASAP!
Duration: Contract-to-Hire Hours: Mon-Fri; 8:30am-5pm Overview Our client is a hospital which is internationally-known referral center for the most complex cases in nearly all areas of medicine.
Some of their specialty areas include: Cancer, Heart, and Vascular.
Requirements: - BS degree required - 2-3 yrs.
of industry clinical trial experience from CRO, Pharma, Biotech or Healthcare setting is required.
- Clinical trial database experience is required - Exp./Familiar with EDC, Medidata, RedCap or Inform is a plus but not required - Fully vaccinated with booster REQUIRED Responsibilities: - Identify and initiate communications with sites to obtain all relevant documents for project/trial.
- Collect and review essential regulatory documents for completeness prior to submitting to Regulatory for final review and/or approval - Advise research sites on protocol conduct, interpretation of protocol, and ensure resolution of issues.
- Evaluate the quality and timeliness of data entry, issue, track and resolve queries, implement corrective action plans as needed.
- Identify issues/trends that require escalation to management and provide input to resolution as appropriate #m3