Clinical Study Start-Up Specialist
Clinical Study Start-Up Specialist
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Job Description
Union: NonUnion
Number of Vacancies: 1
Site: Princess Margaret Cancer Centre
Department: Radiation Medicine Program Clinical Research Program (CRP)
Reports to: Clinical Research Manager
Work Model: Hybrid
Hours: 37.5 hours per week
Shifts: Monday Friday
Status: Permanent Fulltime
Closing Date: June 15 2025
Position Summary:
As a Clinical Research Regulatory StartUp Specialist at UHN you will play a key role in supporting the initiation of clinical trials by ensuring all regulatory and ethics requirements are met. You will collaborate with investigators research coordinators sponsors and regulatory bodies to facilitate timely study startup while maintaining compliance with institutional provincial and federal regulations.
Duties:
- Coordinate and manage the regulatory startup process for new clinical trials within the Radiation Medicine Program.
- Prepare and submit ethics applications to REBs (e.g. UHN REB Clinical Trials Ontario).
- Ensure all required regulatory documents (e.g. investigator CVs financial disclosures delegation logs) are collected and maintained.
- Liaise with sponsors CROs and internal stakeholders to ensure timely responses to queries and document requests.
- Track and report on startup timelines and milestones using internal systems.
- Maintain uptodate knowledge of Health Canada ICHGCP and institutional regulatory requirements.
- Assist in the development and implementation of SOPs and best practices for regulatory compliance.
Qualifications :
- Bachelors degree in Health Sciences Life Sciences or a related field.
- Oncology clinical trials experience preferrred
- Minimum 3 years of experience in clinical research with a focus on regulatory or ethics submissions.
- Familiarity with REB processes Health Canada regulations and ICHGCP guidelines.
- Strong organizational and communication skills.
- Ability to manage multiple projects and deadlines in a fastpaced environment.
- Proficiency in Microsoft Office and clinical trial management systems (CTMS) is an asset.
Additional Information :
Why join UHN
In addition to working alongside some of the most talented and inspiring healthcare professionals in the world UHN offers a wide range of benefits programs and perks. It is the comprehensiveness of these offerings that makes it a differentiating factor allowing you to find value where it matters most to you now and throughout your career at UHN.
- Competitive offer packages
- Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP access to Transit and UHN shuttle service
- A flexible work environment
- Opportunities for development and promotions within a large organization
- Additional perks (multiple corporate discounts including: travel restaurants parking phone plans auto insurance discounts onsite gyms etc.)
Current UHN employees must have successfully completed their probationary period have a good employee record along with satisfactory attendance in accordance with UHNs attendance management program to be eligible for consideration.
All applications must be submitted before the posting close date.
UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.
Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading inaccurate or incorrect UHN reserves the right to discontinue with the consideration of their application.
UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.
We thank all applicants for their interest however only those selected for further consideration will be contacted.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
