Compliance Specialist, Centre for Innovative Medicine - GCP

Interface de l’imprimante
Job Number:
J0422-2165
Job Title:
Compliance Specialist, Centre for Innovative Medicine - GCP
Organisation:
Research Institute of the MUHC
Work Location:
SITE GLEN
Job Category:
Research and teaching
Job Type:
Full time
Shift:
Day
Open Positions:
1

Do you want to work for a world-renowned research institute that pushes the boundaries of biomedical science and health research? Right here in Montreal! At the Research Institute of the McGill University Health Centre (RI-MUHC), you can be part of an organization focused on scientific discovery and innovation in patient-centered medicine. Join us today and make a difference!

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
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).

Under the supervision of the Director of Operations of the Centre for Innovative Medicine (CIM), the Compliance Specialist (CS) is responsible for implementing a Quality Control plan which will include harmonization of CIM processes and documentation between various divisions, and carrying out an overall assessment of quality to ensure that all CIM study activities are conducted as per protocols, Good Clinical Practices (GCP), Research Institute Standard Operating Procedures (RI-SOPs), CIM Work Instructions (CWI), Good Documentation Practices (GDP) and the established governmental guidelines of Health Canada, the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA).

The Compliance Specialist will assist with study conduct and study review, and will coordinate appropriate training activities to ensure that the RI-SOPs and CWI are adhered to. The CS collaborates with CIM Managers, Investigators, and Quality Assurance (QA), tMIhey assist with internal and external audits and review audit reports for the CIM.


General Duties
Quality Control and Compliance:
• Develop and implement the Quality Control plan for the CIM,
• Ensure harmonization of CIM processes between Pediatric/Adult, Oncology and Phase 1,
• Ensure quality across the CIM by sustaining a level of constant inspection readiness,
• Work with managers to ensure quality control for studies and data generated at the CIM,
• Ensure that all study-related documentation is completed accurately and that all procedures are respected as per the RI’s SOPs and CWI,
• Compile, monitoring audits ,monitor signals and trends,
• Support responses to QA reports and keep up good communication,
• Planning, implantation and operation of the QC plan to meet the needs of CIM,
• Coordinate with CIM Manager/Supervisor to address compliance issues,
• Monitor quality, according to GCP (CGLP), regulatory agencies requirements and CWI and RI-SOPs,
• Provide ongoing leadership, advice and counsel on matters of quality issues and process monitoring and improvements,
• Provide guidance, implantation and maintenance of CWI and the RI-SOPs and procedures,
• Develop appropriate corrective and preventive actions (CAPA) and ensure implementation for CIM audit level findings.
• Drive CAPA review, implementation and completion,
• Develop and coordinate policies and procedures necessary to adhere to applicable provincial laws and regulations,
• Coordinate the CIM training and orientation to all CIM employees and other appropriate third parties.
• Establish a process of documentation, tracking, investigation and taking action on all complaints of non-compliance,
• Could be assigned to ensure that the verification of CIM, laboratory and pharmacy instruments is performed as required by RI-SOPs, CWI and ensure Pharmacy procedures,
• Stay up to date on new RI-SOPs, procedures, and techniques via training sessions, team meetings and internal communication avenues.

Administrative:

• Coordinate with QA regarding audit and regulatory awareness,
• Maintain periodic meeting with the managers, supervisors and director of operations,
• Perform any other tasks requested by the manager/CIM Director of Operations.

Website of the organization

https://rimuhc.ca/en



Education / Experience

• Bachelor’s degree in a health-related field or equivalent,
• Bachelor in Nursing is an asset,
• Clinical research accreditation (SoCRA or ACRP) is an asset,
• A minimum of 5 years of quality control (QC) or quality assurance experience (QA) in Clinical research,
• Excellent knowledge of international, federal and provincial laws and regulations governing clinical research (ICH-GCP),
• Experience in clinical research in hospital/clinical setting is an asset,
• Excellent organizational skills, ability to multi-task and prioritizing time-sensitive issues,
• Able to work as part of a team,
• Excellent verbal and written communication skills in French and English.

Additional information

Status : Full-time
Pay Scale: Commensurate with education & work experience
Work Shift: 7 hours per day, 5 days per week. Position may require overtime.
Work Site: Glen Site and remote work is also a possibility

This position requires adequate protection against COVID-19 in light of work site and as per the Government of Quebec decree # 1276-2021 dated September 24, 2021

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.

NOTE: The masculine gender has been used for brevity and includes the feminine gender.

Equal Opportunity Employment Program

Le CUSM applique un programme d’accès à l’égalité en emploi et invite les femmes, les Autochtones, les minorités visibles, les minorités ethniques et les personnes handicapées à présenter leur candidature. Des mesures d’adaptation peuvent être offertes aux personnes handicapées qui en font la demande en fonction de leurs besoins.