Clinical Trial Lead

2 weeks ago


Boston, 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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