Lead Clinical Research Associate - Greater Boston Area (some remote flexibility)
Summary of job description:
The Lead Clinical Research Associate (LCRA) is responsible for overseeing the progress of the Clinical Research Associates (CRA) and clinical sites. LCRA may also conduct monitoring or co-monitoring visits to study sites. Works closely with the Clinical Project Manager (CPM) or Clinical Trial Manager (CTM) to ensure CRA training materials and site facing materials are prepared. Ensures CRA issues and site issues are appropriately addressed and escalated as needed.
- In conjunction with CPM/CTM, prepares and/or reviews monitoring tools and documents, including clinical monitoring plan, trial master file plan, work instructions, training materials
- Reviews monitoring visit reports to ensure adherence to monitoring plan and to address any identified issues or concerns with the quality of the monitoring
- Escalates site or monitoring issues to CPM/CTM and ensures adequate follow-through and tracking of issues
- Addresses protocol or process questions from CRAs
- Develops study specific CRA training materials and trains CRA team as needed
- Co-monitor with CRAs to ensure quality of monitoring
- Assist in routine monitoring as needed
- Assist in process development for in-house monitoring activities
- Present and participate in Investigator Meetings, other training meetings
- Works closely with CTA and CPM/CTM to develop reports and metrics demonstrating adherence to monitoring plan and other agreed upon metrics.
Experience and skill requirement:
- 5+ years of clinical research monitoring experience, in the Pharmaceutical, Biotechnology, or CRO industry
- Bachelor's degree in life sciences, nursing license, or pharmacy
- Solid understanding of FDA and other regulatory requirements that may impact global clinical studies
- Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
- Therapeutic experience in oncology
- Computer skill should include proficiency with Microsoft Office software
If you or a Lead CRA you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself at Sara.Shields (at sign) Realstaffing.com to discuss this role.
Sthree US is acting as an Employment Agency in relation to this vacancy.