Description:

As Lead CRC, you will be responsible for leadership, training, and practice development. The Lead CRC works with the unit CRCs, RAs & management team to review current practices and develop, coordinate, and implement initiatives. Helping to standardize processes, mentor staff, and address or overcome barriers. They lead and advise other CRCs to solve complex study-related problems specific to this position and are responsible for daily supervision of the RAs. Together with the management team, the lead CRC will develop, maintain, and help monitor a training program for CRCs & RAs. They are responsible for providing initial and ongoing staff training and promoting and ensuring adherence to SOPs and working practices, as well as promoting and developing standardization of practices. They maintain effective communication with CRU staff and departments involved with the study protocol and work collaboratively with staff to facilitate communication with outside facilities & study sponsors. The Lead CRC is comfortable with preparing and delivering presentations. They are responsible for clinical trials data management, interpretation, and analysis, providing daily support and vacation/absence coverage as required for data locks, urgent queries, and SAEs by sourcing and interpreting data, liaising with other departments and entering/submitting data and reports as required. They will obtain Superuser status for applicable electronic medical records and apply knowledge to help staff navigate the EMR. They help staff prioritize workflow and assist the Associate Manager to monitor CRC workload. They facilitate site visits and audit processes as required and help coordinate and prepare source documentation for audits or inspections conducted by Study Sponsors, coordinating groups, FDA, or Health Canada. To stay current, the Lead CRC would be the primary CRC on at least one study.

Key Responsibilities:

Additional Required Qualifications:

Preferred Qualifications: