Oncology Clinical Trials Ethics

3 weeks ago

Mississauga, Canada Trillium Health Partners Full time

**Job Description**:
NON - UNION | ONCOLOGY CLINICAL TRIALS

_____________________________________________________________________

**Position**:Oncology Clinical Trials Ethics & Regulatory Coordinator

**File#**:2023-33663

**Status**:Full Time Temporary (x1; approx.18 months)

**Dept/Health System**:Oncology Clinical Trials

**Reports To**:Clinical Trials Manager

**Site**:Credit Valley Hospital

**Shifts/Hours**: 7.5 hr/day; 37.5 hrs/week

**Posted**:June 26, 2023

**Internal Deadline**:July 10th, 2023

_____________________________________________________________________

Trillium Health Partners (THP) is one of the largest community-based acute care facilities in Canada. Comprised of the Credit Valley Hospital, the Mississauga Hospital and the Queensway Health Centre, Trillium Health Partners serves the growing and diverse populations of Mississauga, West Toronto and surrounding communities and is a teaching hospital affiliated with the University of Toronto.

Our Mission**:A New Kind of Health Care for a Healthier Community**

When we set out to build our vision and future, we connected with our community - patients, families, visitors, physicians, staff and volunteers. The foundational goals of our new strategic plan - quality, access and sustainability - anchor everything we do. Our mission for a new kind of health care is built on an inter-connected system of care organized around patients - inside and outside the hospital.

At THP, we are relentless in providing high quality, compassionate care to our communities and take great pride in fostering an inclusive and accessible environment and we are all accountable for contributing to a healthy, safe and respectful environment for healing and promoting excellence in patient care though advancing patient and staff safety. If you are passionate about what you do, motivated to improve the health of the community, committed to excellence, quality and patient safety we would like you to join our Better Together team

**PRIMARY FUNCTION OR PURPOSE OF JOB OR POSITION**

**SPECIFIC DUTIES OR RESPONSIBILITIES**
- Coordinate & facilitate activities related to the preliminary review & selection of new study proposals, including circulation of proposals to disease site leads; obtaining signatures for Confidential Disclosure Agreements; completion of study feasibility questionnaires; coordination of Site Qualification Visits; preparation & circulation of study materials for Scientific Review & Oversight Committee Meetings with input as required
- Completion, maintenance & submission of general & study-specific regulatory documents including CVs, medical licenses, training logs, delegation logs, financial disclosures, etc.
- Prepare for & participate in Audit & Monitoring Visits, including collection of regulatory & ethics documents selected for review; and providing related correction and preventative action (CAPA) responses with input from the trials team as required
- Act as a liaison between Study Sponsors and Oncology Investigators, Clinical Trials team members & enabling depts. for the communication & dissemination of updated study information and clarification of study requirements
- Assessment of study-related issues and the appropriate REB and/or Regulatory documentation, reporting and follow-up action required
- Participate in Quality Assurance & SOP reviews, and departmental process improvement initiatives
- Administrative tasks as required (e.g. filing, faxing, mailing, photocopying, coordination of meetings)

**MAJOR QUALIFICATIONS REQUIRED IN ORDER TO SUCCEED IN THE JOB**

**Formal, Minimum Education Required**:
A Bachelor’s Degree, or recognized equivalent, in a health or science-related discipline

**Previous Related or Special Experience Necessary**:

- Knowledge of basic oncology and medical terminology
- Previous experience with Phase II-IV prospective, interventional, academic and industry oncology clinical trials, minimum of 3 years required
- Knowledge & understanding of research regulations and guidelines (ie. ICH GCP, TCPS) and REB reporting requirements

**Registrations/Membership Requirements**:

- Completion of an accredited Clinical Research diploma or professional certification through SoCRA and/or ACRP.

**LIST REGULAR PRINCIPAL CONTACTS**

Internal: Medical/Radiation/Surgical Oncologists

Clinical Trials Staff

InterProfessional Staff

External: Sponsors

Monitors

Auditors

Research Ethics Boards

**ADDITIONAL COMMENTS**

Requires excellent written & verbal communication, interpersonal, organizational, time-management and critical-thinking skills. Must also be detail-oriented, solution-oriented and able to work independently with mínimal supervision.

Driver’s License or Passport may be required for the purposes of Identity Verification/Proofing (IP) and Multi-Factor Authentication to gain systems access to any US NCI Sponsored trials assigned.

Must be willing to work at both our Credit Valley Hospital and Queensway Health Ce

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