Clinical Study Start Up Specialist - (Permanent Full Time)

Clinical Study Start Up Specialist - (Permanent Full Time) - Toronto, Ontario

JOB TITLE: Clinical Study Start Up Specialist

Job Posting #: 923478

Site: Princess Margaret Hospital

Department: Department of Medical Oncology & Hematology

Reports to: Clinical Research Manager

Hours: 37.5 Hrs.

Salary: $62,717 - $78,406 annually: To commensurate with experience and consistent with UHN compensation policy

Status: Permanent Full-Time

Posted Date: August 10, 2023

Closing Date: Until Filled

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.

Position Summary

The Division of Medical Oncology and Hematology, University Health Network requires a Clinical Trials Launch Specialist to work with its clinical trial portfolio across multiple disease sites.

Duties

The Clinical Trials Launch 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 pharmaceutical companies; performing cross-functional and/or other duties, as assigned.

Qualifications

• Excellent interpersonal skills
• Certification as a Clinical Research Professional, preferred.
• At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
• At least 1 year of experience in data coordination of oncology clinical trials
• 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
• Excellent prioritization skills, excellent computer skills, ability to learn quickly and work independently
• Satisfactory attendance
• 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
• At least two (2) years of practical and related experience in some or all of oncology, clinical trials, medical terminology, regulatory issues involving human subjects

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.

• A flexible work environment
• Close access to Transit and UHN shuttle service
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP https://hoopp.com/ )
• 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.)
• Competitive offer packages

Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.

Vaccines (COVID and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code.

UHN is a respectful, caring, and inclusive workplace. We are committed to championing accessibility, diversity and equal opportunity. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known in advance. Any information received related to an accommodation will be addressed confidentially.

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