Clinical Trial Lead

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