Your Opportunity:

Reporting to the Manager, the Lead Clinical Research Coordinator (Lead CRC) functions as a mentor and serves as an expert resource to the Clinical Research Coordinator (CRCs) and Clinical Research Assistant (RAs) roles within the Clinical Research Unit (CRU). This position has the ability to build and maintain positive relationships, act independently and efficiently, and will be the first point of contact to provide guidance and hands on support for issues that arise daily. This individual can identify trends and provides solutions to any gaps and deficiencies. By reviewing and implementing processes and assisting in staff development the Lead CRC will help streamline and standardize the CRC role within the Unit and improve the job environment. This position will provide functional supervision to the Research Assistants (RAs). The Lead CRC will commit to upholding and promoting the CRU’s Health Canada compliance goals and work in collaboration with the CRU regulatory team. The position will lead staff training and education, and CRC/RA coverage planning in collaboration with the Associate Manager. The lead will proactively learn new clinical trial data entry systems, electronic medical record systems, Clinical Trial Management Software and share knowledge and provide direct support to staff. They participate in quality improvement initiatives to address common learning needs and to develop appropriate CRC/RA training programs. This individual will possess the skills necessary to effectively communicate difficult concepts and to positively influence and motivate others. They will be able to encourage others to adapt workflows, implement new processes and suggest tools and new methods of best practice to optimize work habits and ensure that responsibilities are being met efficiently and effectively, contributing to patient safety and data quality.

Description:

As Lead CRC, you will be responsible for leadership, training and practice development. The Lead CRC works with the unit CRCs, RAs and 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 primary CRC on at least one study.