CCNA National Clinical Research Operations Manager
One Year, Renewable - 70.00 Hours bi-weekly – Non-Union
The Rotman Research Institute (RRI) is a premier international centre for the study of human brain function. The RRI is committed to advancing knowledge of healthy aging and age-related brain disorders, such as dementia, stroke, and sensory loss, by building on its foundational strengths in cognitive neuroscience and its leadership in the innovative use of informatics, electrophysiology, and neuroimaging technologies.
The Canadian Consortium on Neurodegeneration in Aging (CCNA), located in the RRI, was established in 2014 through a grant from the Canadian Institutes of Health Research in partnership with non-profit, pharma, provincial and private funding partners with the goal of catalyzing collaborative research in dementia within Canada. The scientific director is seeking a dynamic, motivated and highly organized individual to oversee a large, multisite clinical research project and related activities undertaken within CCNA and assist in the management of budgets and contracts across the CCNA. The ideal candidate will have had extensive prior experience in multisite clinical research and project management as well as experience with budgeting Candidates must have at least completed a BSc. Candidates with a Project Management Professional certification and experience in research on dementia or a related field will be given preference and are strongly encouraged to apply.
Responsibilities include but are not limited to:
- Assist in hiring and training team to oversee study administration
- Monitor status of study timelines; ensure that study requirements, timelines and deliverables are met
- Provide routine reports to CTU leadership and CCNA partners on the progress towards completion of key miles`tones
- Act as primary contact for questions and issues from site investigators and study teams
- Assist in the analyses and resolution of study specific issues
- Review the protocol, informed consent, and all study related documents
- Ensure the scope of work is respected by the study team
- Generate the study management plan, procedures manual, monitoring plan, recruitment plan, communication plan and CRF content in collaboration with Project leadership and coordination team.
- Organize study start up activities, including investigator recruitment and selection, collection of regulatory documents, and IRB/EC submissions.
- Collect and retain all study essential documents in compliance with GCP/ICH on clinical trial documentation and record retention guidelines
- Review and provide central approval of site-level changes to the initial and all amended versions of the informed consent template
- Oversee implementation of protocol amendments, and associated changes to study related documents.
- Develop study-specific tools as well as project management tools in order to assure consistency and quality of data.
- Create training resources and provide training to internal and external study personnel on protocol, CRF completion, adverse event reporting, central laboratory functioning and all study requirements before the beginning of the study and on an ongoing basis.
- Develop study related procedures, including CRF completion guidelines, rater training guidelines, central biorepository manual, and instructions on wearable devices, in collaboration with CCNA partners responsible for management of these project elements.
- Assist with review and modifications to the prevention program budget as needed throughout the duration of the study
- Work with CCNA research administration team and the Baycrest Rotman Research Institute admin team to finalize CCNA contracts and budgets across CCNA teams.
- Work with CCNA research administration team to ensure accuracy of budgets and timely completion of funding agreements across CCNA teams.
- Master’s or Bachelor’s degree in an appropriate discipline and 6 years of experience in clinical research and 4 years of experience in project management;
- Knowledge of the research area is a strong asset.
- Knowledge of and experience in budget preparation is a strong asset
- French (along with English) language fluency is preferred
- Strong skills in both verbal and written communication
- Outgoing, excellent interpersonal skills
- Ability to work independently and take initiative, set priorities, time-manage, and resolve problems in a fast-paced environment
- Expertise in the following computer programs: MS Word, Excel, PowerPoint, Outlook, Adobe Acrobat, Wordpress)
External applicants: Please submit your application online by clicking the Apply button below.
Internal Expiry Date: August 13, 2020
Posting # 20-0571
Remarkable people of Baycrest Health Sciences are changing the future of brain health and aging.
Thank you for your interest in joining Baycrest. Only those applicants selected for an interview will be contacted. All successful candidates will be required to complete a police reference check/vulnerable sector screen. As staff we all share in maintaining a safe care environment for clients, families, and visitors and a safe work environment for staff, students, researchers, physicians and volunteers. Baycrest 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 notify Human Resources at 416-785-2500, ext. 2961.