Replimune Group, Inc. Woburn , MA 01801
Posted 7 days ago
Overview
Summary of job description:
The Senior Clinical Trial Associate Clinical Operations (SrCTA) will be responsible for supporting the clinical operations team. The SrCTA will participate in clinical activities to support and facilitate the efficient conduct of the clinical research goals. The SrCTA will report to the Director Operational Process.
Responsibilities
Key responsibilities:
Work closely with clinical trial/project manager and study team to support clinical trials
Assist in the development of clinical trial documents including protocols, manuals, SOPs, trackers, policies.
Assist in preparation and documentation of internal and external meetings by preparing agendas and minutes
Assist in updates for all clinical trials tracking tools for Trial Master File (TMF), monitoring visits, enrollment, laboratory samples and clinical trial agents (drugs/biologics), data cleaning, other vendor tracking and training.
Assist in informed consent development and version tracking
Assist in collection and review of essential documents
Assist in update of clinical SOPs, training files on SOPs/other documents
Other Responsibilities:
Assist in reporting for Senior Management updates
Support trial manager in vendor management as needed
Qualifications
Educational requirements:
Experience and skill requirements:
4+years clinical research experience in industry or Contract Research Organization (CRO).
Knowledge and training on Good Clinical Practice (GCP) for clinical research studies
Experience working with clinical sites, principal investigators, clinical operations staff and CROs
Computer skill should include high proficiency with Microsoft Office software
Location:
Replimune Group, Inc.