Clinical Research Coordinator Regulatory, Oncology

2 weeks ago

Montréal, Canada Centre universitaire de santé McGill Full time

Job Description
RESEARCH INSTITUTE OF THE MUHC
The Research Institute of the McGill University Health Centre (RI-MUHC) is a world-renowned biomedical and hospital research centre. Located in Montreal, Quebec, the Institute is the research arm of the McGill University Health Centre (MUHC) affiliated with the Faculty of Medicine at McGill University. The RI-MUHC is supported in part by the Fonds de recherche du Québec - Santé (FRQS).

Position summary
Under the supervision of the Manager, Centre for Innovative Medicine (CIM) and Cedars Cancer Centre (Adults), the Clinical Research Coordinator - Regulatory for Oncology research is responsible for supporting the successful administrative coordination of CCTG (Canadian Cancer Trials Group) and pharma regulatory clinical research activities at the Glen site (Oncology). Provides guidance and support to investigators, clinical research coordinators, research nurses, pharmacists, data entry clerks, CCTG personnel as required.

The Centre for Innovative Medicine is located in the new Glen site hospital which is a unique center in Canada of 5000 m2 dedicated exclusively to clinical research.

General Duties
- Responsible for the coordination and administration of CCTG and pharma activities,
- Acts a resource person for CCTG research activities,
- Responsible for Research Ethics Board CCTG submissions and ensures ethical approvals are current and up-to-date throughout the study,
- Coordinates, completes and maintains regulatory documents for each study,
- Coordinates and maintains training records for each study including but not limited to protocol, amendments, investigator brochures, informed consents, and any other study related documents, GCP, HCDIV5,
- Maintains electronic and paper trial master files for each study,
- Coordinates and assists with quarterly and annual monitoring visits,
- Coordinates and assists with annual audit visits,
- Assists with monitoring and audit reporting responses,
- Assists and ensures investigators and study personnel CTEP/NIH registrations are completed and up-to-date annually,
- Assists study personnel with registration requirements with CTEP/NIH,
- Generate reports for CCTGnd pharma trials, i.e, accrual, study lists,
- May attend CCTG annual Spring meeting, reports updates of new processes and procedures or other relevant information to coordinators, investigators, pharmacy, and other study personnel.
- Assists with data entry when required,
- Assists with coordinating study visits as per study protocol,
- Responds to queries and requests for information,
- Provides coordination of all aspects of data collection and source documentation, as per ICH/GCP guidelines,
- Conducts other related tasks as assigned by supervisor.

Website of the organization

Education / Experience
- DEC in science or related field,
- Minimum 2 years of experience in REB submission, regulatory document requirements and organizing clinical trials,
- Experience in a hospital/clinical setting is preferred,
- Experience in oncology is preferred,
- Experience in clinical research is preferred,
- Knowledge of international, federal and provincial laws and regulations governing clinical research is an asset, ICH-GCP, HC DIV5.
- Bilingual (French and English),
- Autonomous, flexible sense of ethics and good judgement,
- Excellent organization, ability to multitask and prioritize time-sensitive issues,
- Excellent interpersonal skills,
- Solid written and verbal communication skills,
- Ability to work under mínimal supervision,
- Resourceful and responsible,
- Highly proficient in MS Office (Word, Excel),
- Strong analytical and problem-solving skills,
- Must be a team player.

Additional information

**Status**: Temporary Full time (one-year contract renewable)

**Pay Scale**: $41,223.00 - $76,549.20
Commensurate with qualifications and experience

**Work Shift**: from 8:30 a.m. to 4:30 p.m., Mondays to Fridays (35-hour workweek) needs to be flexible when needed. Some overtime is required.

**Work Site**: Glen Site (1001 Décarie) and may have to travel on occasion.

Why work with us?
- 4-week vacation, 5th week after 5 years,
- Paid time off during the Holidays,
- Bank of 12 paid days (personal days and days for sickness or family obligations),
- 13 paid statutory holidays,
- Modular group insurance plan (including gender affirmation coverage),
- RREGOP government pension plan (defined benefit),
- Courses and professional development opportunities,
- Flex work options and much more

THIS IS NOT A HOSPITAL POSITION.
Equal Opportunity Employment Program

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