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Job Posting: 864995
Position: Clinical Research Data and Regulatory Coordinator
Site: Princess Margaret Cancer Centre
Department: Radiation Medicine Program
Reports to: Clinical Research Manager
Pay Scale: $29.10 - $36.37 per hour (Commensurate with experience and consistent with UHN Compensation Policy)
Hours: 35 hours per week
Status: Temporary Full-time
University Health Network (UHN) is looking for an experienced professional to fill the key role of Clinical Research Data and Regulatory Coordinator in our Radiation Medicine Program.
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 Rehabilitation Institute, Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre 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 five 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.
• Provides strong support to investigators for reviewing clinical trial protocol, supporting documents (consent forms, CAPCR application) using effective writing styles capable for conveying clear consistent guidelines for trial operation while consistent with GCP.
• Preparing, reviewing and submitting Clinical Trials Protocols and Research Ethics Board (REB) applications.
• Coordinates all aspects of trial start up
• Responsible for Amendments submissions including Health Canada
• Collection, completion and submission of regulatory documents to various regulatory entities
• Ensures filling and completion of all regulatory documentation in the Regulatory Binders
• Responsible for archiving the Investigator Study Files upon completion of studies
• Liaises between site and sponsor to ensure that all trial-related documentation and information are distributed to relevant staff
• Gathers information and background in response to inquiries and issues raised; responds to request for information regarding regulatory aspects of clinical trials
• Keeps the Regulatory Database, study team and RMP website updated with any study amendments
• Assists with the preparation of regulatory documents for monitoring, QAR or external audits
• Perform cross-functional responsibilities and other duties, as assigned.
• Completion of a Bachelor degree in a science- or health-related discipline.
• Preferred 2 years of relevant experience in clinical trial procedures and/or regulatory affairs, including research ethic board (REB) policies and procedures.
• Strong knowledge of Good Clinical Practice Guidelines
DESIRED SKILL SET:
• Must be proficient in English grammar, excellent verbal and written communication skills with exceptional interpersonal skills.
• Excellent computer skills including Microsoft Office Suite and general ability to use database applications.
• Strong understanding of radiation and medical oncology practices;
• Strong command of medical terminology.
• Meticulous work ethic and attention to detail, with excellent time-management and organizational skills.
• Ability to manage competing demands of short and long-term projects led by numerous individuals, directing multiple varied assignments, independently coordinating and prioritizing relevant projects, tasks and responsibilities.
• Highly motivated and adaptable with an ability to take initiative and work well independently and as part of a multidisciplinary team.
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.
POSTED DATE: October 8, 2020 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. 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.
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