Sr Clinical Trial Associate
Lead Clinical Research Associate- Cambridge (1-2 days of remote flexibility)
Seeking a highly motivated scientist to work in their Analytics group to help shepherd a multi-targeted T cell therapy to the clinic. As the Lead Clinical Research Associate (LCRA) you may also conduct monitoring or co-monitoring visits to study sites. The LCRA works closely with the Senior Global Clinical Project Manager (CPM) to ensure CRA training materials and site facing materials are prepared as well as ensures CRA issues and site issues are appropriately addressed and escalated as needed.
- In conjunction with GCPM, 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 GCPM 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 GCPM to develop reports and metrics demonstrating adherence to monitoring plan and other agreed upon metrics.
Experience and skill requirement:
- 2+ years of clinical research monitoring experience, in the Pharmaceutical, Biotechnology, or CRO industry
- Bachelor's degree in life sciences, nursing license, or pharmacy preferred
- Exposure to Immunology, Cell Biology, Biochemistry, Biological Engineering or closely related field preferred
- Understanding of FDA and other regulatory requirements that may impact global clinical studies preferred
- Knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management preferred
If you or a Clinical Research Associate you know feel this could be an opportunity you would like to explore please send your most up to date resume to myself (at sign) to discuss this role.
Sthree US is acting as an Employment Business in relation to this vacancy.