Clinical Research Coordinator - Regulatory Affairs (Research Institute)

Centre Universitaire de santé McGill
$44,408 - $82,427 a year
Quebec
Full time
1 day ago

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 direct supervision of the Manager of Research, Centre for Innovative Medicine (CIM), the Clinical Research Coordinator – Regulatory is responsible for supporting the successful conduct of clinical research studies in the Centre for Innovative Medicine.

General Duties
  • Review and revise sponsor’s informed consent forms so that it meets FRSQ standard approved language,
  • Work with sponsors and study teams to obtain all documents required to start submissions,
  • Submit studies through Nagano to reviewing committees (ethics and site specific reviews),
  • Maintain on going communication with Ethics, Contracts, Investigators, and Sponsors during submission and renewal timelines to ensure that all needs are meet met,
  • Optimize study review time,
  • Primary point of contact for all stakeholders,
  • Conduct other related tasks as assigned by manager.

Website of the organization

https://rimuhc.ca/en


Education / Experience

Education: DEC in science

Experience: Experience in ethics and/or regulatory submissions is a definite asset

Required Skills

  • Knowledge of clinical research, hospital/clinical setting is preferred,
  • Minimum 2 year of experience in ethics and/or regulatory submissions is a definite asset,
  • Experience working with the Nagano platform and/or Clinical Trial Management System (CTMS) is an asset,
  • Knowledge of international, federal and provincial laws and regulations governing clinical research (ICH-GCP) is an asset,
  • Able to multi-task and prioritize workload
  • Organized,
  • Bilingual: French and English spoken and written,
  • Solid written and verbal communication skills,
  • Able to work under minimal supervision,
  • Quick learner, detail orientation, good adaptability and versatile,
  • Excellent knowledge of computer skills, as well as Word, Excel and PowerPoint,
  • Knowledge of Nagano systems an asset, and
  • Self-directed, organized and sense of ethics.

Additional information

Status : Full-time
Pay Scale: $ $44,408.00- $82,427.80 Commensurate with education & work experience
Work Shift: 8:30 a.m. to 4:30p.m., Mondays to Fridays (35hours/week)
Work Site: Glen Site, Montreal General Hospital

***If you wish to include a cover letter, please attach it with your resume in one document. ***

Why work with us?

  • 4-week vacation, 5th week after 5 years,
  • 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),
  • Telemedicine,
  • RREGOP (defined benefit government pension plan),
  • Training and professional development opportunities,
  • Child Care Centres,
  • Corporate Discounts (OPUS + Perkopolis),
  • Competitive monthly parking rate,
  • Employee Assistance Program,
  • Recognition Program,
  • Flex work options and much more!

https://rimuhc.ca/careers

To learn more about our benefits, please visit http://rimuhc.ca/en/compensation-and-benefits

THIS IS NOT A HOSPITAL POSITION.

Equal Opportunity Employment Program

The Research Institute of the McGill University Health Centre hires on the basis of merit and is strongly committed to equity, diversity and inclusion within its community. We welcome applications from all qualified candidates who self-identify as members of racialized groups/visible minorities, women, Indigenous persons, persons with disabilities, ethnic minorities, and 2SLGBTQIA+ persons. We also welcome candidates with the skills and knowledge to productively engage with diverse communities. Persons with disabilities who anticipate needing accommodations for any part of the application process may confidentially contact, research.talent@muhc.mcgill.ca

Apply
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