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Lead Clinical Research Associate
Department: Clinical Development
Reports to: Director/Senior Clinical Project Manager or Clinical Trial Manager
Location: Woburn Office or Remote
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.
- Bachelor’s degree in life sciences, nursing license, or pharmacy
Experience and skill requirement:
- Five or more years of clinical research monitoring experience, in the Pharmaceutical, Biotechnology, or CRO industry
- 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