Job Description

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 \xe2\x80\x9cabove all else the needs of patients come first\xe2\x80\x9d, 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 \xe2\x80\x9cTransforming lives and communities through excellence in care, discovery and learning\xe2\x80\x9d, the University Health Network (UHN), Canada\xe2\x80\x99s 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.

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
• Validates the significant and relevant aspects of the subject\'s medical history, assessing baseline adverse events and concomitant medications, previous treatments and response to them. (e.g Determining the grade and stage of cancer. Assessing the dates of diagnosis and recurrence and/or progression and entering into CRF\xe2\x80\x99s.)
• 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\xe2\x80\x99s attention.
• Obtains and submits all relevant diagnostic, laboratory, pathologic etc. reports when required to sponsors to provide corroboration of information recorded in CRF\xe2\x80\x99s

Responsible for maintaining systems for effective data flow and ensuring timeliness of submission for CRF\xe2\x80\x99s

QUALIFICATIONS:

• At minimum, completion of a Bachelor\xe2\x80\x99s degree program, or recognized equivalent, in a health or science-related discipline
• At least one (1) to two (2) years clinical and/or professional experience
• Clinical Research Graduate certificate is preferred
• Demonstrated relevant clinical research knowledge
• Excellent written and verbal communication skills, excellent organization, prioritization skills, good computer skills, ability to learn quickly and work independently
• Excellent interpersonal skills
• Ability to work under pressure and 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
• Ability to perform multiple concurrent tasks
• 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

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.

POSTED DATE: March 3, 2023 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.

University Health Network