Job Description

JOB POSTING # 908805

Position: Clinical Study Start Up Specialist
Site: Princess Margaret Cancer Centre
Department: Clinical Trials Support Unit, Cancer Clinical Research Unit (CCRU)
Reports to: Clinical Research Manager, CTSU
Salary Range: $66,534 - $83,168 per annum (Commensurate with experience and consistent with UHN Compensation Policy)
Hours: 37.5 hours per week
Status: Permanent Full-time

University Health Network (UHN) is looking for an experienced professional to fill the key role of Clinical Study Start Up Specialist in our Clinical Trials Support Unit Department.

Transforming lives and communities through excellence in care, discovery and learning.

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 at UHN. 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 groundbreaking 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.

University Health Network (UHN) is a research hospital affiliated with the University of Toronto and a member of the Toronto Academic Health Science Network. The scope of research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care. Research across UHN's seven research institutes spans the full spectrum of diseases and disciplines, including cancer, cardiovascular sciences, transplantation, neural and sensory sciences, musculoskeletal health, rehabilitation sciences, and community and population health. Find out about our purpose, values and principles here.

The Clinical Trials Support Unit, University Health Network requires a Clinical Study Start Up Specialist to work with its clinical trial portfolio across multiple disease sites.

The Clinical Study Start Up Specialist participates in the pre-activation phase of a clinical trial from protocol review and approval through to activation. Responsibilities include, but are not limited to, preparation of initial submissions to the Research Ethics Board and CAPCR system, set-up and maintenance of regulatory and study documentation, and liaising and negotiating with various internal and external stakeholders in accordance with ICH-GCP, FDA and US federal code, and Tri-Council regulations; interpreting the applicable regulations and maintain regulatory compliance; utilizing quality assurance procedures to ensure accuracy of regulatory materials submitted for review; maintaining responsibility of study activation for a wide variety of research projects involving phase, I, II, and III trials sponsored by various cooperative groups, academic institutions, investigators and pharmaceutical companies; performing cross-functional and/or other duties, as assigned.

QUALIFICATIONS

• At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science related discipline
• At least 3-4 years of practical and related experience in some or all of oncology, clinical trials, medical terminology, regulatory issues involving human subjects
• At least one (1) year of experience in data coordination of oncology clinical trials
• Previous experience with regulatory/ethics submissions (initial, amendments) preferred
• Excellent prioritization skills, excellent computer skills, ability to learn quickly and work independently
• Excellent interpersonal skills
• Ability to work under pressure and perform multiple concurrent tasks with a high level of attention to detail
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
• Knowledge of applicable legislative, UHN and/or departmental policies
• Client service oriented, with the ability to effectively work with diversity and appreciate that people with different opinions, backgrounds and characteristics bring richness to the challenge or situation at hand
• Satisfactory attendance
• Certification as a Clinical Research Professional, preferred

POSTED DATE: October 26, 2022 CLOSING DATE: Until Filled

For current UHN employees, only those who have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, and possess all the required experience and qualifications should apply.

University Health Network thanks all applicants, however, only those selected for an interview will be contacted.

UHN is a respectful, caring, and inclusive workplace. We are committed to championing accessibility, diversity and equal opportunity and welcomes all applicants including but not limited to: all religions and ethnicities, LGBTQ2s+, BIPOC, persons with disabilities and all others who may contribute to the further diversification of ideas. Requests for accommodation can be made at any stage of the recruitment process providing the applicant has met the Bona-fide requirements for the open position. Applicants need to make their requirements known when contacted.

Improving the patient's experience through patient centered care! For additional information on patient centered care please go to: www.nrcpicker.com