Research Coordinator

4 months ago

Brampton, Canada William Osler Health System Full time

**Company Description**
One of Canada's Best Diversity Employers and Greater Toronto's Top Employers for many consecutive years, William Osler Health System (Osler) provides a safe and supportive health care network to grow your career. Osler is nationally recognized for its commitment to patient safety and is Accredited with Exemplary Standing, the highest rating a Canadian hospital can receive. As a major Ontario hospital system, and home to some of the biggest specialty and emergency departments in the country, Osler serves the 1.3 million residents of Brampton, Etobicoke and surrounding communities. We are proud to offer you incredible exposure to best-in-class health care delivery and challenging hands-on opportunities to stay at the top of your game.

A hospital system built for and by the community, we continue to expand our services to meet the needs of a growing population, creating opportunities for increased hands-on skills development, cross-department training and promotional opportunities. Guided by our accomplished senior leadership team, together we are driving our vision of patient-inspired health care without boundaries.

At Osler, we invest in careers that go beyond where health care professionals like you can achieve their goals and find deep personal and professional fulfillment. Join our team today

The Regulatory Research Coordinator reports to the Manager of Research, Oncology, with accountability to the Oncology leadership team.

Accountabilities:

- Manages all aspects of regulatory oversight for trials, from start-up through study closeout, and protocols in development
- Works closely and collaborates with research manager and principal investigator to develop and complete necessary documentation prior to start-up activities
- Develops, reviews and edits informed consent documents, ensuring compliance with local and sponsor regulations
- Reports pertinent safety data and deviation notifications to the REB
- Prepares, reviews, and submits - under principal investigator delegation -safety reports quarterly or annually
- Adheres to all appropriate regulations in the conduct of research
- Develops function scorecard and track progress of start up activities
- Maintains study trial delegation of responsibility logs and keeps record of all training documentation for site staff; tracks training requirements and ensures all training is completed
- Facilitates internal and external monitoring and auditing of regulatory files by the sponsor, contract research organization, or other entity; ensure regulatory binders are organized, complete and up to date prior to monitoring visit or audit
- Reviews and adapts existing standard operating procedures, templates, databases and organizational systems as developed for the management of regulatory and quality assurance activities
- Maintains regulatory binders, ensuring all relevant sections of binder are organized, complete and up to date
- Ensures accurate and timely data collection, transcription, and entry; timely reporting of adverse events and serious adverse events to study sponsor, physician and appropriate authorities; resolves sponsor queries
- Participates in educational programs, workshops and seminars to broaden knowledge, update and develop new skills
- Represents the Oncology Department at protocol development, study initiation and investigator meetings

**Qualifications**
- Undergraduate certificate or Bachelor's degree in health science or related field
- Experienced research professional (SOCRA Certification required)
- Minimum two years working experience as a regulatory coordinator, including designing and reviewing informed consent documents for interventional drug trials
- Strong working knowledge of Canadian, American and international regulatory guidelines
- Expert knowledge of Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Health Canada’s Part C Division 5 of the Food and Drug Regulations and FDA regulations
- Expert knowledge of electronic REB submissions, including Clinical Trials Ontario
- Experience in Oncology clinical trials is an asset
- Flexible and cooperative spirit with a strong commitment to team efforts
- Proven ability to prioritize workload and meet deadlines
- Outcome-drive self-starter with the ability to work independently
- Excellent organizational, prioritization, and time-management skills
- Must demonstrate Osler's Values of Respect, Excellence, Services, Compassion, Innovation and Collaboration

**Additional Information**

Remote First Role: Roles that can function primarily remotely but require essential, occasional onsite work

Annual salary:
Minimum: $77,200.50
Maximum: $96,505.50

Application deadline: September 25, 2024

LI-WD1

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While we thank all applicants, only those selected for an interview will be contacted. Any information obtained during the course of recruitment will be used for employment recruitment purposes only, and not for any other purpose.

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