Clinical Study and Regulatory Specialist I

3 weeks ago

Toronto, Canada University Health Network Full time

**JOB POSTING # (915619)**

Position**: Clinical Study and Regulatory Specialist I (6 positions)**
Site: Princess Margaret Cancer Centre
Department: Division of Medical Oncology and Hematology
Reports to: Clinical Research Manager
Salary Range: $62,166 to $77,688 per annum (Commensurate with experience and consistent with the UHN Compensation Policy)
Hours: 37.5hrs/week, Monday to Friday, 9am to 5pm
Status: Permanent Full-Time (Hybrid)

**University Health Network (UHN) **is looking for an experienced professional to fill the key role of** Clinical Study and Regulatory Specialist I** in our Division of Medical Oncology and Hematology.
- 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.

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

**The Clinical Study & Regulatory Specialist** participates in the coordination of clinical trials from protocol review and approval through to activation, follow up and trial closure. Principal responsibilities include monitoring and promoting the quality and integrity of data, recording clinical trial data in case report forms (CRFs), and compilation of ethics and regulatory documents. The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice. Data is assessed, compiled, recorded and submitted to cooperative groups and/or pharmaceutical companies or used for internal PMH studies. All data must be complete, accurate, timely and must be in compliance with applicable ICH-GCP, FDA and US federal code and Tri-Council regulations. The Clinical Study & Regulatory Specialist 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** leads study and regulatory coordination from activation to close-out of Phase I, II, and III clinical studies. Principal responsibilities include the following:

- Participates in the planning and implementation of clinical research protocols
- Organizes remote and onsite monitoring visits for audits by external sponsors, internal and/or external regulatory agencies
- May prepare submissions in CAPCR for amendments to site contracts
- Creates or amends source templates for documentation purposes in accordance with data management requirements
- Organizes site initiation visits and protocol reviews including presentations and source documentation collection
- Reviews, evaluates and verifies clinical data to ensure accurate and timely completion of internal, pharmaceutical company and cooperative group case report forms (CRF's) in either paper or electronic format.
- Verifies patient eligibility for study participation based on medical records in accordance with protocol requirements
- Confirm protocol treatment drug doses to ensure accuracy and to ensure that any protocol specified dosage modifications have been made correctly and any discrepancies brought to the Principal Investigator’s attention.
- Obtains and submits all relevant diagnostic, laboratory, pathologic etc. reports when required to sponsors to provide corroboration of information recorded in CRF’s
Responsible for mai

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