Job Posting #890804
Position: Clinical Trials Launch Specialist (Clinical Data Coordinator II)
Site: Princess Margaret Cancer Centre
Department: Division of Medical Oncology and Hematology, Department of Medicine
Reports to: Clinical Research Manager, DMOH
Salary Range: $62,166 - $77,688 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 Trials Launch Specialist (Clinical Data Coordinator II) in our Medical Oncology and Hematology 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 Division of Medical Oncology and Hematology, University Health Network requires a Clinical Trials Launch Specialist (Clinical Data Coordinator II) to work with its clinical trial portfolio across multiple disease sites.
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:
At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science related discipline
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
At least one (1) year of experience in data coordination of oncology clinical trials
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
Vaccines (COVID-19 and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code
Vaccines (COVID-19 and others) are a requirement of the job unless you have an exemption on a medical ground pursuant to the Ontario Human Rights Code
If you are interested in making your contribution at UHN, please apply on-line. You will be asked to copy and paste as well as attach your resume and covering letter. You will also be required to complete some initial screening questions.
Posting Date: December 23, 2021 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.