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Clinical Research Specialist III - AHRC - Clinical Trials Unit
Job Title:Clinical Research Specialist III - AHRC - Clinical Trials Unit
Department:AHRC - Clinical Trials Unit
New Work Type:Full-Time Permanent
Salary Range:$34.60 - $43.25 per hour
FTE Assignment (Cas=0.000001):1.0
The Applied Health Research Centre (AHRC) of the Li Ka Shing Knowledge Institute is an Academic Research Organization (ARO) that provides clinical study project coordination and data management services to Investigators and sponsors at the University of Toronto, and beyond. The AHRC supports and manages all aspects of the clinical trials process including protocol development, study document development, clinical site management, clinical data management, data analysis and reporting. This position will offer the successful applicant a challenging and rewarding career in clinical research.
The AHRC will be acting as the data coordination centre (DCC) for a large, complex, multinational, commercially sponsored clinical trial in the cardiology therapeutic area. As such we are hiring a Clinical Research Specialist III (CRS III) position to lead the DCC team within AHRC (5+ staff). The role of the DCC will be to manage the central data repository and manage the data flow from various data repositories (CIHI, others) into the eCRF; to oversee the eCRF data validation/management processes; to oversee the remote source data verification process; and to work closely with the in-house statistical team to lead the statistical aspects of the trial. The CRS-III will also work closely with the contracts team to negotiate clinical trial contracts with Canadian trial sites. The CRS III will be responsible for meeting study milestones on time and within budget. Duties will involve: overseeing all aspects of the data coordination for this large, multi-national trial, and working closely with the sponsor, the study project lead, the co-principal Investigators, the in-house staff, and statistical staff to ensure the quick resolution of issues and the timely progress of activities.
DUTIES & RESPONSIBILITIES:
- Lead the data coordination centre (DCC) activities for a large, complex, multi-national trial, including oversight/coordination of 5+ dedicated staff members
- Oversee the development of the study eCRF and associated clinical data management documents; develop data transfer specifications; perform user testing and validation of the eCRF and associated online tools; troubleshoot issues as they arise
- Coordinate study eCRF training materials and perform site training
- Coordinate and oversee data validation activities, including remote source data verification activities
- Coordinate the development of the statistical analysis plan (SAP)
- Ensure conduct of research is carried out in accordance with ICH/GCP guidelines and applicable regulations, as well as SOPs
- Work collaboratively with internal team members, external stakeholders, vendors and consultants.
- Bachelors Degree in a scientific discipline required, plus 5+ year of research-related experience in clinical trial data management and/or clinical trial management (pharma experience would be an asset)
- Ability to understand and interpret complex clinical study protocols
- Strong leadership skills with the ability to manage multiple responsibilities and meet challenging study timelines, and respond quickly to time-sensitive issues
- Excellent written and verbal communication skills with ability to work both independently and in a team environment
- Familiarity with ICH/GCP guidelines and the Canadian regulatory environment
- Familiarity with large data repositories such as CIHI would be an asset