Clinical Study and Regulatory Specialist I

Company Description

The University Health Network, where "above all else the needs of patients come first", encompasses Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute and the Michener Institute of Education.

The breadth of research, the complexity of the cases treated, and the magnitude of its educational enterprise has made UHN a national and international resource for patient care, research and education.

With a long tradition of ground breaking firsts and a purpose of "Transforming lives and communities through excellence in care, discovery and learning", the University Health Network (UHN), Canada's largest research teaching hospital, brings together over 16,000 employees, more than 1,200 physicians, 8,000+ students, and many volunteers.

UHN is a caring, creative place where amazing people are amazing the world.

Job Description

Job Description

Union : Non-Union

Site : Princess Margaret Cancer Centre

Department : Cancer Genomics Program

Reports to : Senior Program Manager

Work Model : Hybrid (on-site 1 day per week, remote 4 days per week)

Grade : N0 : 06

Hours : hours per week

Salary : $64,974 - $81,218 per annum. To be commensurate with experience and consistent with UHN compensation policy.

Status : Permanent Full-time

Closing Date : July 18, 2024

Position Summary

The Cancer Genomics Program (CGP) is a research program at the Princess Margaret Cancer Centre dedicated to advancing personalized cancer medicine through the identification of underlying genetic mutations and molecular mechanisms that drive cancer.

The program's oncology clinical research portfolio includes a broad spectrum of genomics trials across multiple cancer types.

The CGP team provides management and coordination for all of its trials and is in need of a Clinical Study and Regulatory Specialist I at this time.

The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol review and regulatory approval through to activation, follow-up and trial closure.

Additionally, the Specialist I performs comprehensive clinical data abstraction for select cancer genomics studies for which data are shared through national and international collaborations.

Primary responsibilities include :

• Research Ethics Board submissions, study document creation / review, consent form collection rounds, clinical data abstraction from medical charts and other source documents into electronic case report forms (eCRFs), and query resolution.
• The coordination of data abstraction is performed in accordance with the study protocol, hospital and departmental guidelines, and professional standards of practice.
• All data must be completed in an accurate and timeline manner and must be in compliance with applicable ICH-GCP, Tri-Council, and federal regulations.
• The Clinical Study and Regulatory Specialist I must be able to interpret the applicable regulations in order to ensure compliance.
• Quality assurance procedures are utilized to ensure high quality data is obtained.
• The Clinical Study and Regulatory Specialist I also undertakes study-related administrative tasks such as organizing meetings, taking minutes, and obtaining signatures.

Qualifications

• At minimum, the completion of a Bachelor's degree program, or recognized equivalent in Health or Science-Related Discipline
• At least two (2) years of experience in some or all of oncology, clinical trials, medical terminology and regulatory issues involving human subjects
• At least one (1) year of experience in the review and preparation of Research Ethics Board submissions
• Demonstrated relevant clinical research knowledge
• High proficiency in Microsoft Excel
• Excellent written and verbal communication skills, excellent organization, prioritization skills, computer skills, ability to learn quickly and work independently
• Excellent interpersonal skills
• Ability to work under pressure and attend to details
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with UHN standards
• Ability to perform multiple concurrent tasks
• Knowledge of applicable legislative, UHN and / or departmental policies
• Satisfactory attendance
• Certification as a Clinical Research Professional is preferred

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 )
• Close 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, on-site gyms, etc.)

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.

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire.

Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN’s mandatory Vaccination Policy that is in effect.

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.

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.

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire.

Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN’s mandatory Vaccination Policy that is in effect.

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.