Project Manager - Centre for Clinical Trial Support (CCTS) - Temporary Full-Time (12-month contract)(030121)

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Sunnybrook Research Institute (SRI) is a $100M multidisciplinary research community, fully affiliated with the University of Toronto, and servicing a broad spectrum of research programs and platforms. The Centre for Clinical Trial Support (CCTS) is SRI’s coordinating centre in support of investigator-driven clinical research projects and clinical trials. We are seeking a Project Manager to manage the central daily operations of multi-centered Health Canada regulated clinical trials related to COVID.

Summary of Duties (not all-encompassing):

Project Management

• Manage research activities for project, including study start-up, active phase, analysis, and closeout; ensuring compliance with study protocol and regulatory requirements
• Central contact for project, including study Principal Investigator, clinicians, coordinators, funding agencies, stakeholders
• Facilitate study agreement negotiations
• Maintain appropriate regulatory documents and correspondence for sites/personnel
• Provide training and ongoing support to all participating sites
• Write progress reports for funding agencies

Monitoring

• Responsible for reviewing or preparing a clinical monitoring plan
• Conduct monitoring visits: to ensure site compliance and adherence to study protocol and applicable regulatory guidelines (Health Canada, FDA, ICH-GCP, etc) both remotely and on-site as required
• Responsible for creating and distributing data monitoring reports and action item lists to site staff post visit; responsible for follow up with site investigator until completion
• Assists in preparing for and responding to regulatory inspections

Data Management

• Responsible for data management (logging, tracking in database, entry, verification, reporting of data, ensuring protocol compliance)
• Directly involved in site communication regarding data management (queries, overdue data entry, requesting supporting documents, providing site support for data related inquiries)
• Manage adverse event reporting, including expedited reporting to Health Canada for all Serious and Unexpected Adverse Drug Reaction (SUADRs)

Qualifications/Skills/Requirements

• Candidates should have at least 5 years of clinical research experience (management of multi-centre clinical trials)
• Excellent interpersonal skills
• Strong communication and presentation skills
• Strong writing and editing skills
• Demonstrated knowledge of current policies, guidelines (ICH-GCP), standards, and applicable regulations in order to ensure own work is in compliance and to provide technical and administrative guidance to staff
• SoCRA certification, or the equivalent, is an asset
• Bilingual (French), is an asset
• Able to meet competing deadlines while paying meticulous attention to detail
• Knowledge of Electronic Data Capture (EDC) programs, preferably REDCap
• Skill using various computer systems and software programs including: database management, word processing, spreadsheet and presentation applications, (MS Office)

Please apply in writing including a cover letter, resume, and references to:

The Centre for Clinical Trial Support

Sunnybrook Research Institute

C8 - 2075 Bayview Ave.

Toronto, Ontario M4N 3M5

FAX: 416-480-5633

Email: ccts@sunnybrook.ca

Only applicants who are to be interviewed will be contacted. DEADLINE: March 14, 2021

Sunnybrook Research Institute is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please indicate this in your cover letter.

Sunnybrook Research Institute is strongly committed to inclusion and diversity within its community and welcomes all applicants including but not limited to: visible minorities, all religions and ethnicities, persons with disabilities, LGBTQ persons, and all others who may contribute to the further diversification of ideas.

Sunnybrook Research Institute is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please indicate this in your cover letter.

Sunnybrook Research Institute is strongly committed to inclusion and diversity within its community and welcomes all applicants including but not limited to: visible minorities, all religions and ethnicities, persons with disabilities, LGBTQ persons, and all others who may contribute to the further diversification of ideas.

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