Clinical Study and Regulatory Specialist Ii - Toronto, Canada - University Health Network

University Health Network

Verified Company

Toronto, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

JOB POSTING #

Position
:
Clinical Study and Regulatory Specialist II

Site:
Princess Margaret Cancer Centre

Department:
Division of Medical Oncology & Hematology - Clinical Trials Group

Reports to:
Manager, DMOH-CTG

Salary Range:
$67,197 to $84,006 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 II in our Division of Medical Oncology and Hematology - Clinical Trials Group

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
Clinical Study and Regulatory Specialist II participates in the coordination of clinical trials from protocol activation and follow up to 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 pharmaceutical companies or used for internal 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 and Regulatory Specialist II 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.

Responsibilities include:

Work closely with internal teams during preactivation to develop study flow to ensure readiness for activation.
Working knowledge of BMT-IEC SOPs and forms, FACT regulations;
Liaise and build rapport with various hospital departments (SOC and research); Escalate any site issues to Management
Perform crossfunctional and/or other duties as assigned

Requirements:

At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science Related Discipline
At least Three years of experience in clinical trials in Oncology
Experience with regulatory submissions and Site Management activities
Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance with UHN/Department standards
Excellent written and verbal communication skills, excellent organization, prioritization skills, ability to learn quickly and work independently
Compliance with confidentiality requirements
Strong problem solving and decision making skills with ability to exercise initiative
Excellent interpersonal skills, Ability to work under pressure and attention to detail
Knowledge of applicable legislative, UHN and/or departmental policies
Client service oriented

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.

POSTED DATE:
May 7, 2023

CLOSING DATE:
June 7, 2023
For current UHN employees, only those who have successfully completed their probationary period, have a good employee record along with satisfactory attendance in