| POSITION TITLE |
Clinical Trials Coordinator II |
| DEPARTMENT |
LTRI (The Urologic Oncology Group) |
| EMPLOYMENT TYPE |
Temporary, Full-Time |
| HOURS OF WORK |
37.5 hours per week |
| EMPLOYEE GROUP |
Non-Union |
| REPORTS TO |
Principal Investigator |
ORGANIZATION DESCRIPTION:
The Lunenfeld-Tanenbaum Research Institute (LTRI) of Mount Sinai Hospital, a University of Toronto affiliated research centre, is one of the world's leading centres in biomedical research. With ground-breaking discoveries in research areas such as diabetes, genetic disorders, cancer and women’s and infants’ health, the Institute is committed to excellence in health research and the training of young investigators. Strong partnerships with the clinical programs of Mount Sinai Hospital ensure that scientific knowledge is used to promote human health. Your significant contributions will assist in maintaining our momentum in advancing our research.
DEPARTMENT & POSITION DESCRIPTION:
The Urologic Oncology Group within the Division of Urology is focused on interventional Phase 1-3 clinical trials in Bladder, Prostate and Kidney Cancer, working closely with industry sponsors. In addition to industry sponsored trials, our group has a strong record of conducting novel investigator initiated trials. This is a rare ground-floor opportunity to help seed a dedicated clinical trials unit. The successful candidate will work under the supervision of the Principal Investigator (Dr. Satkunasivam) as the lead coordinator for our Trial Unit. The PI has extensive experience in clinical trial design and execution, having grown the research team from a single coordinator in 2019 to a group of ten, and this position is expected to function at a level below a research manager, with strong emphasis on project management, team development, and professional growth towards leadership opportunities. There is significant growth ahead: the unit is expanding, a research fellow is already in place, and additional coordinators will be hired over time.
The successful candidate will lead the growth of the unit, including the hiring and onboarding of future research coordinators, and will mentor coordinators within the Division whose background is in outcomes research rather than interventional trials, building interventional-trial capability across the team.
DUTIES AND RESPONSIBILITIES:
- Work with Principal Investigator to coordinate the study start up from engagement with industry sponsors, budget-negotiation, contracting, activation, coordination monitoring, billing reconciliation, and study close-out
- Under the Principal Investigator’s supervision, administer investigational product (IP) in accordance with the protocol, including accountability, handling, storage, dispensing records, and reconciliation
- Hire, onboard and supervise future research coordinators as the unit grows, and mentor Division coordinators whose background is in outcomes research to build their capability in interventional clinical trials
- Create SOPs for the urologic oncology group that aligns with Hospital and REB policies
- Day-to day-coordination and implementation of multi-site research trials and the research unit
- Collaborate with sponsors and maintain external site file documentation, such as collection of regulatory documents, submission to the Research Ethics Board and other regulatory agencies as required
- Participate in cross-network patient engagement activities
- Organize research team meetings; building strong supportive relationships amongst diverse knowledge users
- Prepare study documents and templates (i.e. CRFs, study logs) and coordinate all aspects of data collection and source documentation as per Sinai’s policy and ICH/GCP guidelines
- Manage REDCap Database- review and monitor study data; issue external accounts
- Recruit study participants (e.g. identify, screen potential participants & obtain informed consent)
- Liaise on behalf of the sponsor with external stakeholders & members of the clinical site research team
- Organize and prepare for monitoring visits and/or audits
- Contribute to protocol development
- Collaborate with multidisciplinary team to identify, recruit and consent eligible participants in research trials
- Review participant eligibility as per the inclusion/exclusion criteria for the study with Principal Investigator
- Work closely with the Principal Investigator to identify, document, and report adverse events to the sponsor, REB, and regulatory authorities as required.
- Execute study related administrative tasks and perform basic administrative duties including filing and photocopying
- Review and assess study related literature, liaise with sponsor for monitoring/audits.
- Other tasks as assigned
SKILLS/QUALIFICATIONS:
- University undergraduate degree in a related specialty (Biological or Health Sciences)
- SOCRA Certified Clinical Research Professional (CCRP)
- Minimum of three years experience in the coordination and administration of clinical trials
- Prior experience with research regulatory submissions (i.e. Clinical Trials Ontario)
- Proficiency in computer applications including Word, Excel, and PowerPoint, Adobe Illustrator
- Strong relational and communication skills (oral and written)
- Sound decision-making and problem solving skills - works well under pressure and uses good judgment in assessing difficult situations
- Exceptional organizational & time management skills & attention to detail
- Ability to multi-task & perform with accuracy in a fast-paced environment
- Excellent problem-solving skills
- Self-motivated; ability to work well independently as well as part of a team
- Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to Sinai’s standards
- Ability to manage several concurrent tasks while meeting predetermined timelines
- Demonstrate the ability to quickly become familiar with organizational, office, and research practices, procedures, and standards.
Additional preferred experience:
- Experience mentoring or supervising junior coordinators or research staff
- Familiarity in site contracts is preferred
- Previous experience with multi-site interventional oncology trials, both industry and investigator initiated, is preferred
- Demonstrated industry-sponsored trial experience, having previously run multiple concurrent trials from start-up through close-out
- Hands-on experience administering investigational product (IP), including accountability, dispensing and reconciliation
- Proven study start-up and execution, including sponsor engagement, budget-negotiation, contracting and site activation
Hourly pay range: $37.149 – $39.585
In accordance with Institute’s policy and legislated health and safety requirements, employment is conditional upon the verification of credentials, completion of a health review, and demonstrating proof of immunity and vaccination status of vaccine-preventable diseases. All employees and affiliates will follow safe work practices and comply with health and safety policies, procedures, and training. Successful candidates will be required to provide two (2) written reference letters from their former employer(s)/supervisor(s).
We are a fully committed to fairness and equity in employment and our recruitment and selection practices. We encourage applications from Indigenous peoples, people with disabilities, members of sexual minority groups, members of racialized groups, women and any others who may contribute to the further diversification of our Sinai Health community. Accommodation will be provided in all parts of the hiring process as required under our Access for People with Disabilities policy. Applicants need to make their requirements known in advance.
The Lunenfeld-Tanenbaum Research Institute is a scent sensitive environment, and all members of the community are expected to refrain from wearing or using scented products while visiting or working at the Institute. We also support a barrier-free workplace supported by the Institute’s accessibility plan, accommodation and disability management policies and procedures. Should you require accommodation at any point during the recruitment process, including accessible job postings, please contact the Lunenfeld-Tanenbaum Human Resources Department.
Our hiring process uses job posting portals that screen relevant keywords, followed by a review from a human recruiter.
| Posting open until August 10, 2026. We thank all candidates for applying. Only those selected for an interview will be contacted. |
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