The Options Collaboratory (www.optionslab.ca) is currently looking for a dynamic team player with excellent clinical project management skills to join our research team as a full-time Project Manager II. Our lab is an interdisciplinary research team dedicated to bringing together community, academic, clinical, and policy partners to find and implement new and better options for the treatment and prevention of HIV and other sexually transmitted infections (STIs) and emerging infectious diseases. We are housed within the MAP Centre for Urban Health Solutions (www.maphealth.ca) and conduct clinical and implementation science research within the Division of Infectious Diseases at St. Michaels Hospital.

The primary role of the Project Manager for the PRECISE Clinical Platform is to support the development and implementation of a new research project. PRECISE (Prepare, REact, Collect, Innovate, Share and Engage) is an exciting new multi-component pandemic preparedness project funded by the Canada Biomedical Research Fund that seeks to develop an agile, equitable research and bio-manufacturing response to emerging infectious disease threats. The Clinical Platform of PRECISE is charged with the design of a master protocol for longitudinal prospective cohort studies, featuring comprehensive data and bio-specimen collection from individuals with emerging infections, and their close contacts. The project is planned to be implemented across an initial network of 17 adult and pediatric infectious diseases research sites across community and academic hospitals in Ontario.
To help launch this important work, we are seeking a highly organized and independent team player to serve as a Project Manager for the PRECISE Clinical Platform. Key responsibilities for the Project Manager will include: creating the Master Protocol, case report forms, consent forms and related study documents, securing and maintaining Research Ethics Board approvals, developing standard operating procedures suitable for this large multi-institutional collaboration, building, training, evaluating and supporting a team of research coordinators across different organizations, ensuring meaningful community engagement, and overseeing the day-to-day operations and budget of this complex project. Reporting to our team of four Co-Principal Investigators, the Project manager will work alongside an interdisciplinary professional team including the staff and leadership of other components of PRECISE. The ideal candidate will have exceptional organizational, interpersonal and leadership skills.




Primary Responsibilities:
Project Design and Management

• Assists in the design of a multicenter prospective cohort for studying infectious diseases with a focus on pathogens that could result in pandemics
• Develops, distributes and maintains study protocols, including amendments across multiple research sites
• Develop processes for the collection, identification, transfer and storage of diverse biospecimens
• Designs and ensures informed consent documents and other administrative documents including institutional and sponsor requirements for each participating site
• Assists in the design and curation of study database and clinical data collection forms
• Creates work plans and timelines to be followed by the research team
• Coordinates and monitors study progress including the tracking of study targets and milestones to help ensure they are met
• Prepares project reports for management, sponsors, or other authorities

Clinical Research Administration:

• Manages clinical research requirements of the prospective cohort including overseeing Research Ethics Board application(s), amendments and renewals from all participating institutions
• Communicates with the Research Ethics Board at participating hospitals as required
• Develops and negotiates Data Sharing Agreements and Material Transfer Agreements (including terms of financing) with outside parties
• Exercises professional judgment in regulatory conduct of research activities, and ensures adherence to local, national, and international regulations on conduct of research studies (PIPA, PIPEDA, ICH/GCP).
• Develops workload templates and budgets for personnel, services, resources where required
• Develops, maintains and/or authorizes budgets, payment schedules, and creation/updates of financial reporting
• Financial management/oversight of the project
• Procures necessary supplies and services for the project/program

Communication

• Hires, trains, evaluates and manages a team of research coordinators, research assistants and students in collaboration with the team
• Oversees workload of the team
• Plans, manages, and handles communications with stakeholders (including collaborators, funders and community members) related to research projects in collaboration with the Director and Co-Director
• Coordinates joint and local investigator meetings
• Assists with effective human resource allocation through recruitment, selection, training, and performance management.
• Builds and fosters effective working relationships with study sites, related study personnel and other stakeholders.

Qualifications

• Project Management Professional (PMP) certification (Required)
• MSc or above in Infectious Disease, Microbiology, Immunology, Cell Biology or a science- related discipline or recognized healthcare professional degree.
• At least 5 years of experience in clinical research project management or equivalent leadership role.
• Experience in infectious/communicable disease research preferred.
• Experience with research budgets and contract negotiations and management.
• Current certification in Good Clinical Practice, Ethical Conduct for Research Involving Humans, and Transportation of Dangerous Goods
• Superior interpersonal skills and attention to detail
• Excellent problem-solving and organizational skills and ability to respond rapidly to change
• Experience with clinical databases such as REDCap, Metidata Rave or In Form
• Ability to work well as part of a multidisciplinary team

How to Apply:
Please submit CV and cover letter. Applications without a cover letter will not be considered.


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