Research Facilitator, Regulatory

3 months ago

Vancouver, Canada University of British Columbia Full time

Staff - Non Union

Job Category

M&P - AAPS

Job Profile

AAPS Salaried - Research and Facilitation, Level A

Job Title

Research Facilitator, Regulatory & Quality

Department

Clinical Research Unit | Vancouver Coastal Health Research Institute | Faculty of Medicine

Compensation Range

$5,365.42 - $7,709.92 CAD Monthly

The Compensation Range is the span between the minimum and maximum base salary for a position. The midpoint of the range is approximately halfway between the minimum and the maximum and represents an employee that possesses full job knowledge, qualifications and experience for the position. In the normal course, employees will be hired, transferred or promoted between the minimum and midpoint of the salary range for a job.

Posting End Date

September 18, 2024

Note: Applications will be accepted until 11:59 PM on the Posting End Date.

Job End Date

At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.

Job Description Summary
The VCHRI CRU Research Facilitator, Regulatory & Quality is responsible quality assurance, regulatory and start-up projects, supporting clinical investigators with all aspects of pre and post review of ethics submissions and assisting with a range of general research activities in the Vancouver Coastal Health Research Institute Clinical Research Unit (VCHRI CRU). These duties include the day to day running of the VCHRI CRU involving planning, coordination, implementation, evaluation, communication and management of research studies with an emphasis on Quality, in terms of (a) quality planning, (b) quality assurance, (c) quality control, and (d) quality improvement. Some researchers only require assistance with a few responsibilities while others ask for assistance related to their entire study from start to finish. Researchers enter into an agreement with the VCHRI CRU at the outset to outline the various levels of service needed from the VCHRI CRU as they relate to sponsored clinical trials, investigator initiated and grant funded trials. Multiple trials are always underway at any given time.

**Job Description**:
At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.

Organizational Status
The Research Facilitator, Regulatory & Quality reports to the Director, VCHRI CRU Clinical Research Unit. The incumbent will interact with other members of the VCHRI CRU/research teams as well as other hospital groups & health care professionals including clinicians/researchers, coordinators, students, sponsors, auditors, volunteers and study participants.

Work Performed

Provides leadership in the on-going development of the VCHRI CRU.

Advises investigators on policy/processes and procedures and/or prepares regulatory document requirements.

Reviews and provides in-house expertise by performing quality assurance, quality planning, quality control, and quality improvement using quality management system (QMS) encompassing the controlled document system (i.e. SOPS & WPAs), CAPA/deviation reporting, CQI, compliance (training), risk management, audit-readiness etc.

Prepare and participate in monitoring and regulatory agency visits.

Writes VCHRI CRU procedures as required for study visits and procedures.

As requested obtains or assists investigators with ethics submissions/approvals for sponsored clinical trials, investigator initiated and grant funded trials. Includes providing advice/guidance to clinical research staff at all levels (from physicians to coordinators) on the UBC Research Ethics Board (REB), university, health authority, TCPS 2 policies, Health Canada, etc policies and procedures.

Ensuring development, implementation, and adherence to all organizational and clinical standard operating procedures across all research programs.

Plans and organizes clinical trials in accordance with good clinical practice guidelines (GCP).

Develops and oversees study progress, including recruitment, data collection and analysis safety, assessments, tracking of Adverse Events, Serious Adverse Events and protocol deviations. Resolve concerns relating to the research undertakings that may be expressed by taking direct action to address issues in a timely manner and/or bringing them to the attention of the study investigators.

Interprets requirements for Investigator-initiated studies where there may or may not be a funding agreement in place. Ensures proposa

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