Job#: 1284238 Job Description:
Lead Clinical Research Associate 1284238Location:
Cambridge, MA (HYBRID)Science:
Predominantly early stage developmentTherapeutic Areas
: Multiple therapeutic areasJob Overview
: The Lead CRA will work with the Clinical Operations team members to assist in overseeing vendors and clinical sites participating in clinical studies from concept to close-out. Responsibilities:
- Collaborate with Clinical Operations Lead (COL) and study team to support select clinical study activities, in accordance with established protocols.
- Assist in the identification and selection of vendors and provide oversight support in conjunction with the COL.
- Assess/review/ensure CRO monitoring quality and CRA capabilities, perform co-monitoring visits as needed, review Monitoring Visit Reports (MVRs) and MVR metrics and assist with site training, etc.
- Evaluate ongoing site performance and onsite review source documents from a Sponsor's perspective to ensure compliance with the protocol
- BA/BS and 5 or more years of CRA experience with direct clinical trial, vendor oversight. Ex-US trial experience is a plus and biotech/pharma/medical industry preferred
- Experience in early-stage clinical development is strongly preferred
- Timeline management skills, experience with Microsoft Project is a plus
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