Ri-23-036 Quality Assurance

3 weeks ago

Ottawa, Canada CHEO RESEARCH INSTITUTE Full time

**JOB DESCRIPTION**
**Posting Number: RI-23-036**

**Posting Date: July 17, 2023 - July 31, 2023**

**POSITION: Quality Assurance & Regulatory Compliance Officer**

Office of Research Services

**TERM**:Permanent, Full-time 1.0 FTE - (Hybrid Role)

**SALARY**:$70,000-$80,000 annually

**REPORTS TO**:Quality Assurance & Regulatory Compliance Manager

The Children’s Hospital of Eastern Ontario Research Institute (“CHEO RI”) is the research arm of the Children’s
Hospital of Eastern Ontario - Ottawa Children’s Treatment Centre (“CHEO”) and an affiliated institute of the
University of Ottawa. CHEO is a beloved institution and workplace that is widely recognized for being an anchor in our community. CHEO RI works to create new knowledge and evidence to support CHEO in its provision of world-class care to our children. Our mission at CHEORI is to connect exceptional talent and technology in pursuit of life-changing research for every child, youth, and family in our community and beyond.

**CHEO RI has an immediate requirement for a Quality Assurance & Regulatory Compliance Officer.**

Quality Assurance (QA) & Regulatory Compliance Officer will be required to conduct mandatory pre-study activations for investigator-initiated trials and ensure oversight and compliance of regulated research trials at
CHEO.

The position involves conducting routine monitoring, directed audits and privacy reviews, to verify compliance and quality assurance, and report findings as per established process. The QA & Regulatory Compliance Officer will be expected to promote and educate clinical researchers regarding the regulations, guidelines, and best practices for the conduct of clinical research and to develop, implement, and maintain training manuals

**RESPONSIBILITIES**
- Conduct regulatory review processes for all investigator-initiated regulated research submitted to the

Research Ethics Board (REB) and Health Canada for review
- Facilitate regulatory inspections across the Institution by ensuring research teams and hospital support areas are prepared
- Act as a consultant/expert resource to advise, guide, educate and train the CHEO clinical research community regarding methods to maintain high standards of quality research, and the mitigate potential risks arising from the conduct of clinical research, by sharing and educating staff about regulations, guidelines, and best practices
- Communicate and promote the use of institution-wide standard operating procedures for the conduct of clinical research
- Develop and maintain templates and resources to guide clinical research staff in the conduct of clinical research to facilitate regulatory compliance
- Liaise with research team members (locally and/or at study sites), REB staff, CHEO Grants, Contracts and Finance staff, study sponsors and others as required
- Identify ongoing education and support needs of the CHEO research community
- Deliver education sessions to clinical research staff on a variety of topics, including Clinical Trial

Applications, International Conference on Harmonization - Good Clinical Practice (ICH-GCP), SOPs, Part C Division 5, privacy regulations (provincial and federal), best practices, etc.
- Maintain current distribution lists for regulated researchers and research professionals
- Develop and maintain content for the CHEO RI Web pages
- Work with the CHEO Epic team to facilitate access for external monitors
- Perform other related duties as assigned by Manager

**QUALIFICATIONS, SKILLS AND ABILITIES**
- Bachelor’s degree Essential
- Advanced degree in Health Sciences, Health Care Administration, or another related field Preferred
- Current Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Preferred

Professionals certification (ACRP)
- A minimum of 3 years’ experience in clinical research is required, including coordinating, or Essential managing clinical trials
- Experience with Research Ethics Boards and Health Canada Essential
- Knowledge of Clinical Trial Applications, Canadian Regulations [Part C Division 5, Part 4 Essential

(Natural Health Products) and Part 3 (Medical Devices), United States Code of Federal
Regulations (CFR), clinical trial registration, etc.
- Certificate demonstrating competency in Tri-Council Policy Statement (TCPS2): Ethical Essential

Conduct for Research Involving Humans and International Conference on Harmonization
- Good Clinical Practice (ICH-GCP)
- Experience in monitoring, auditing, or inspection activities Preferred
- Experience delivering presentations Essential
- Excellent organizational and time management skills Essential
- Strong written, verbal, and analytical skills and the ability to manage multiple activities Essential simultaneously
- Demonstrated initiative, excellent use of judgment and discretion Essential
- Excellent people skills Essential
- Self-directed, detail oriented and enjoy working as a member of a team Essential

**WORKING CONDITIONS**
- Cli

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