Clinical Research Specialist Ii Ahrc Clinical Tria
2 weeks ago
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 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 II will be to manage and coordinate assigned multi-site clinical trials, working closely with the sponsor, vendors and the internal AHRC team. The CRS II will be responsible for meeting study milestones on time and within budget. Duties may involve writing study protocols and research reports, site selection, site management, training of internal and external staff, obtaining regulatory approvals, overseeing study monitoring/QA activities, leading the development of the eCRF and study database, overseeing data validation activities and responding to issues, preparing study documents, managing study meeting coordination, tracking study progress, tracking the study budget, internal and external study audits, communicating with the internal study team as well as the study sponsor, vendors, academic partners, and sites, and ensuring that issues are resolved in a timely manner.
**DUTIES & RESPONSIBILITIES**:
- Central coordination of multi-centre clinical trials
- Develop and distribute study-related documents, such as the protocol, study operational manual, master informed consent form, study templates, and other study documents as needed
- Support site selection, site training and site start-up activities
- Coordinate development of the study eCRF and associated clinical data management documents
- Perform regulatory and safety submissions to Health Canada, as required
- 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 oversee data validation activities
- Coordinate and oversee reporting and analytical activities
- Coordinate study payments and oversee the study financials
- Coordinate and oversee study contracting activities
- Coordinate and/or perform some onsite clinical monitoring
- 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.
**QUALIFICATIONS**:
- Bachelors Degree in a scientific discipline required, plus 3+ year of research-related experience
- Master’s degree and/or CCRP 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
- In depth knowledge of ICH/GCP guidelines and the Canadian regulatory environment
- Data management and/or monitoring experience an asset
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Toronto, Canada St. Michael's Hospital Full timeThe 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...
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