The Evaluative Clinical Sciences Research Platform is seeking a Project Manager to join the Tory Trauma Program team. This role involves upholding best practices in managing the BALANCE+ adaptive platform trial as well as other investigator-initiated and industry-sponsored research studies, including Health Canada-regulated clinical trials. In addition, the Project Manager duties include overseeing all Canadian and International sites participating in BALANCE+, participating in protocol development and updates, organizing legal contracts, developing and updating research ethics approvals locally and provincially, and managing database related issues including, but not limited to, data cleaning and validation. This is an on-site position.

Key Responsibilities and Activities:

• Initiates and oversees local and provincial research ethics submissions.

• Initiates and oversees inter-site legal contracts.

• Manages the central study database, and ensures timeliness and accuracy of data submitted by participating study sites.

• Communicates effectively with all participating sites to ensure seamless start up, ongoing monitoring during study and effective close out at end of study.

• Assists in study administration and study management: ability to adhere to research protocols and to carry out various aspects of conducting of a research study or a clinical trial.

• Collaborates with the Investigator and other members of the study team.

• Attends and participates in project-related meetings, including research team meetings

• Plans, implements and coordinates all aspects of data collection and maintenance of study documentation as per hospital policy and ICH/GCP guidelines.

• Identifies problems using assessment skills and reports any concerns in a timely fashion.

• Executes study related administrative tasks, including: scheduling participant visits, conducts recruitment interviews, obtains informed consent, collects and enters data and coordinating patient visits/schedule as per study protocol.

• Reviews and assesses study related literature, liaises with sponsor, prepares and participates in study audits or monitoring activities

• Maintains and reports on all administrative, regulatory and study documents subject to applicable guidelines

• Initiates, manages, and coordinates submissions to Research Ethics Board and contracts for Legal Review

• Maintains up to date training and certifications including GCP, TCPS2, and any other study-related required training

• Assists with financial duties relating to research study – related-activities: such as liaising with Research Finance as necessary for activities such as new account setup, annual reporting, budget management, invoice verification, etc.

• Liaises with SRI Research Finance and Sunnybrook Foundation as necessary for activities such as new account setup, annual reporting, budget management, donations, etc

• Orders and maintains study-related equipment and supplies.

• Provides functional supervision to assigned personnel (i.e., trainees and students) and assists in the training and orientation of new staff.

• Helps oversee completion of data entry at external sites participating in trials led by this study team

• Helps educate personnel at external sites on study protocols

• Communicates clearly and respectfully with patients and colleagues

• Demonstrates the ability to multitask and solve problems in an independent manner.

• Participates in protocol development, may conduct own research in collaboration with other team members, may present research results at local, national and international scientific meetings, presents seminars and in-services internally and provides functional supervision of assigned personnel.

Qualifications/Special Skills include:

• Master’s degree in health sciences discipline or BSc with 5 years in a clinical research setting

• Experience recruiting participants, conducting assessments, and managing multiple studies.

• Proficient in patient chart reviews and familiar with study data entry and management platforms (e.g., REDCap). It would be desirable to skills allowing REDCap modifications responsive to trial conduct.

• Strong interpersonal skills and ability to maintain professional communication and maintain positive relationships with staff and research participants

• Strong organizational skills with the ability to prioritize tasks while maintaining attention to detail.

• Computer proficiency including skills with MS office applications

• Strong work ethic with an ability to solve problems independently

Applications: Qualified applicants should submit their interest in this position with an up-to-date resume and brief description of how they qualify for this position.

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, LGBTQAI2S+ persons, and all others who may contribute to the further diversification of ideas.