Clinical Research Associate Manager Jobs in Quebec

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Position Summary:

The Clinical Research Unit (CRU) of the Montreal Neurological Institute-Hospital (the Neuro) conducts over 120 clinical trials and clinical research projects in adult neuroscience. Project Leads design and write protocols for investigator-initiated clinical studies to be conducted within The Neuro CRU in close collaboration with investigators, academic researchers, funding agencies, industry partners, expert consultant and vendors. They also oversee the conduct of these clinical trials once initiated.

Primary Responsibilities:

• Manage clinical research projects at the Neuro CRU.

• Design and write protocols for investigator-initiated clinical studies to be conducted within The Neuro CRU in close collaboration with investigators, academic researchers, funding agencies, industry partners, expert consultant and vendors.

• Ensure that grants and publications are written in accordance with policies and procedures as approved by the University and other parties, including sponsors.

• Ensure the timely submission of grant proposals to secure funding for studies.

• Collaborate in the preparation and timely submission of all required documentation, and any necessary revisions, for approval by the institutional Research Ethics Board (REB) and, where relevant, by regulatory authorities (e.g. Health Canada, FDA).

• Define operating procedures and timelines to ensure smooth delivery of multiple project activities. Thisencompasses study assessment logistics, sample processing and data collection (including provisions for banking for future scientific research and development/maintenance of electronic data capture systems), sourcing study equipment and outcome measures, participant recruitment and engagement activities, and communication/outreach activities.

• Collaborate on study contracts/agreements and finances, including budget development, with relevant CRU and McGill departments and external sub-sites, if applicable.

• Oversee sponsor-related aspects of investigator-initiated study execution, including data quality control and interim/end-of study analyses (in consultation with study statistician), monitoring, documentation, communications, data/safety committees, and multi-site management if applicable.

• Inform physicians, researchers, granting agencies and pharmaceutical companies about proposals and publications that are generated by and through the CRU.

• Document and write detailed reports on project processes and outcomes.

• Provide training to new Clinical Research Coordinators on internally developed protocols, as needed.

• Support clinicians and PIs associated with the CRU in the conception, writing, editing and submission of posters, publications, dossiers and presentations.

• Provide information and advice to researchers, project leads and coordinators on the preparation of investigator-initiated trial proposals.

• Participate in the development of local and national initiatives as needed to facilitate pre-clinical and clinical research in neurological diseases.

• Prepareannual reports for CRU activities/projects, as necessary

• Collaborate with the development office in writing required documents for donor and other funding opportunities.

• Attend national and international research conferences and meetings to network with key people needed for project and trial development and to stay up-to-date on research and trial design progress in the diseases under investigation.

• Establish and maintain external partnerships and collaborations to expand IIT team portfolio.

• Diversify the CRU's project portfolio via the Outreach program initiative.

Other Qualifying Skills and/or Abilities:

• PhD preferred.
• Previous experience in clinical research, clinical trial design, and project management is an asset.
• Proven organizational skills.
• Must be able to manage multiple activities and projects simultaneously.
• Ability to troubleshoot, solve problems, take initiative, and prioritize work.
• Leadership capabilities, must be able to manage and support others.
• At ease with technology, and troubleshooting tech-related problems.

As one of Montreal's Top Employers, here is what we offer:

• Competitive benefits package (Health, Dental, Life Insurance) (if eligible)

• Defined contribution pension plan (with employer contribution up to 10%) (if eligible)

• Group Registered Retirement Savings Plan (RRSP) and Tax Free Savings Account (TFSA)

• Competitive vacation policy

• Two (2) personal days

• Two (2) floating holidays

• Nine (9) "Summer Fridays" - paid days off between the St-Jean Baptiste holiday and Labour Day

• Paid time off over the December holiday period

• Tuition waiver for regular employees and their dependents

• Up to two (2) days of remote work per week where the position permits

Before applying, please note that to work at McGill University, you must be both authorized to work in Canada and willing to work in the province of Quebec at the campus where the position is based / located.
Knowledge of English: McGill University is an English-language university where day to day duties may require English communication both verbally and in writing. The level of English required for this position has been assessed at a level 4 on a scale of 0-4.

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