Clinical Research Specialist I Ahrc Clinical Trial

2 weeks ago

Toronto, Canada St. Michael's Hospital Full time

The Applied Health Research Centre (AHRC) of the Li Ka Shing Knowledge Institute is an exciting new Academic Research Organization (ARO) that provides clinical study project coordination and data management services to Investigators and sponsors at St. Michael’s Hospital, 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 report writing. This position will offer the successful applicant a challenging and rewarding career in the clinical research area.

The primary role of the Clinical Research Specialist I is to support the central coordination activities of multi-site clinical trials, to ensure studies are carried out according to the study protocol and as per applicable regulatory guidelines, and that projects are completed on time and within budget. This position requires the ability to understand complex research protocols, to lead study tasks independently, and to communicate effectively with a large variety of stakeholders. The successful applicant will work closely with investigators, study team members, study coordinators, sponsors and vendors. The Clinical Research Specialist I will report to the Research Manager and must be flexible to work beyond the job description at times as work demands.

**DUTIES & RESPONSIBILITIES**:

- Support central coordination of multi-centre clinical studies
- Develop and distribute study-related documents, such as the master Informed Consent Form, study aids, and other study documents
- Coordinate development of the study CRF and associated clinical data management documents
- Coordinate study training materials and perform site training
- Perform regulatory submissions for investigational testing authorization to Health Canada
- Oversee and track site REB approvals and provide support as needed
- Manage the study supplies; track incoming/outgoing study materials
- Address complex protocol-related questions
- Coordinate study-related meetings
- Track study recruitment and other study milestones; develop the study recruitment plan
- Coordinate and/or perform data validation activities
- Coordinate and/or perform onsite clinical monitoring
- Ensure conduct of research is carried out in accordance with ICH/GCP guidelines and applicable regulations, as well as local SOPs
- Work collaboratively with internal team members, external stakeholders, vendors and consultants.

**QUALIFICATIONS**:

- Bachelors Degree in a scientific discipline required, plus 2+ years of clinical trials-related experience
- Master’s degree and/or CCRP/ACRP certification and/or PMP certification is 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
- 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 is preferred; training will be provided

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