Job Description

NON - UNION | ONCOLOGY CLINICAL TRIALS



Position: Oncology Clinical Trials Ethics & Regulatory Coordinator

File#: 2023-33442

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 12, 2023

Internal Deadline: June 19th, 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

The Clinical Trials Ethics & Regulatory Coordinator will be primarily responsible for liaising with Oncology Investigators, Clinical Trials Study team members, internal departments, Research Ethics Boards (REB) & Study Sponsors to ensure the timely submission, review & activation of new studies and study amendments. The Ethics & Regulatory Coordinator is also responsible for ensuring the ongoing maintenance of all ethics & regulatory documents & approvals as well as other trials-related duties assigned. Within this role, the Ethics & Regulatory Coordinator will work collaboratively with the study team to ensure all aspects of the studies are conducted in adherence with regulatory and REB reporting requirements for the protections of human subjects\xe2\x80\x99 research, applicable institutional policies and procedures, departmental standard operating procedures and protocol requirements.

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
• Coordinate & facilitate activities related to the activation & implementation of new studies, including review of protocol & modification of consent forms; participating in feasibility reviews; providing input for study budgets; preparing & circulating department impact review documents; obtaining signatures for study agreements; completing & submitting initial Research Ethics Board applications; preparation, collection & submission of regulatory documents; organizing Study Start-up Meetings; disseminating required training materials
• Completion & submission of Research Ethics Board (REB) applications including annual renewals; amendments; local Serious Adverse Events; protocol deviations; etc.; communication & dissemination of updated REB-approved study documents to relevant study team members & requirements for implementation (ie. training, re-consent, etc)
• 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\xe2\x80\x99s 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
• Demonstrated experience in the preparation of regulatory documentation & Research Ethics Board (REB) applications & submission processes (ie. OCREB, Local REB)
• 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 minimal supervision.

Driver\xe2\x80\x99s License or Passport will 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 Centre Cancer Centre locations, as required.

Flexibility to work remotely on occasion, based on operational needs.

Internal Candidates who believe they possess the necessary qualifications and experience for this position and who have been in their current position for at least six (6) months are encouraged to apply.

To pursue this career opportunity, please visit our website:

Trillium Health Partners is an equal opportunity employer committed to fostering a healthy, safe and respectful environment for healing, based on our values compassion, excellence and courage. To be Better Together, we commit to fostering a respectful workplace culture that promotes a safe and supportive environment for everyone who provides care, supports caregiving, receives care or visits the hospital.

In accordance with the Accessibility for Ontarians with Disabilities Act, 2005 and the Ontario Human Rights Code Trillium Health Partners will provide accommodations throughout the recruitment and selection process to applicants with disabilities. If selected to participate in the recruitment and selection process, please inform Human Resources of the nature of any accommodation(s) that you may require in respect of any materials or processes used to ensure your equal participation.

All personal information is collected under the authority of the Freedom of Information and Protection of Privacy Act.

Trillium Health Partners is identified under the French Language Services Act.

We thank all those who apply but only those selected for further consideration will be contacted.

Trillium Health Partners