Clinical Affairs CoordinatorApply Now
Location: Bedford, Massachusetts 01730
Employment Type: Contract
Contract Length: 6 months
Job Summary: The Clinical Affairs Coordinator is responsible for providing administrative support in order to facilitate the management of pre-approval and post-approval clinical trial processes. The position supports all activity of study management from start-up to closeout. The Clinical Affairs Coordinator will assist with other Regulatory/Clinical activities as assigned.
- Create and maintain Trial Master Files for all clinical studies and archive study documents for completed clinical trials; assist sites in maintaining complete onsite investigator files
- Oversee Regulatory document collection process
- Maintain study tracking systems (e.g. TMF inventory, investigational product, clinical documents, site visit schedules etc.)
- Distribute, collect, and track study documentation accurately and within project timelines; verify content to ensure quality
- Assist with the organization and administrative activities with regards to investigator meetings; keep meeting minutes and distribute as required
- Participate in the creation of study aides/materials
Experience, Knowledge, and Skills Required:
- Bachelor’s degree in the life sciences
- Excellent computer skills specifically with Microsoft Office Suite
- Excellent organization and the ability to focus on detailed work
- Demonstrated ability to communicate effectively in both verbal and written formats
- Capable of working independently as well as in project teams
As a Senior Recruiter, Michael Liuzza brings almost a decade of sourcing and hiring experience to the JVT team. In his current role, Michael is responsible for full lifecycle recruiting, partnering with JVT's Contract Recruiting Team to match superior available talent with career building opportunities.
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