Clinical Trial Manager
7 days ago
**Summary of Position**:
**Description of tasks**:
- Ensure study protocol and regulatory requirements are met prior to initiating recruitment at all test sites;
- Ensure regular communication with the principal investigator (and sponsor), co-investigators at other test sites, and research staff at other test sites to ensure high quality data collection;
- Liaise with the Research Ethics Board (REB) of the CIUSSS ODIM and Health Canada. Prepare submission documents such as the informed consent, and ensure follow-up communications;
- Ensure storage and accountability of investigational product at the Douglas and other test sites;
- Keep participant files and the Trial Master File up to date;
- Follow specific training courses for the study; ensure that site personnel certifications are up to date; train staff in study procedures;
- Monitor data entered at all test sites. Review all Adverse Drug Reaction reports in a timely way, and ensure they are managed according to protocol, including contacting the necessary research personnel and Health Canada/the REB when necessary.
- Participate in weekly and monthly internal operations meetings and external meetings with sponsors and CROs (Travel may be required).
- Recruit study participants and obtain informed consent from participants and/or caregivers;
- Review medical records and patient references, identify potential study participants according to protocol inclusion / exclusion criteria;
- Perform visit-related tasks and procedures, and document all data in patient source documents, including preparation and shipment of laboratory samples and data entry;
**Required qualifications**:
- Minimum 1 year experience in clinical studies; multicentric, an asset;
- Bilingual: French and English (spoken and written).
- Not required but an asset:
- Experience liaising with Health Canada for pharmaceutical clinical trials
- Experience working with REDCap databases and research management software
**Required abilities**:
- Collaborative, motivated, organized, and solutions-driven.
- Attention to detail, able to balance multiple priorities.
- Builds trusting relationships with collaborators.
- Ability to work effectively within a diverse team and to work independently.
**Location of work**:
On site position at the Douglas Mental Health Research Centre (Frank B.Common pavilion)
**Work schedule**:
Full-time - 35 hours per week
**Salary**:
$ 70,000-80,000 + benefits, commensurate with experience and education
**Will be required to travel for work?**:
Infrequently
**Name of immediate supervisor**:
Dr Simon Ducharme
**Salary**: $70,000.00-$80,000.00 per year
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Verdun, QC: reliably commute or plan to relocate before starting work (required)
**Education**:
- Bachelor's Degree (required)
**Experience**:
- clinical studies: 1 year (preferred)
**Language**:
- English (required)
- French (required)
Work Location: One location
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