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Clinical Trial Lead

2 months ago

Roxbury Crossing, United States Joulé Full time

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

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