Clinical Study and Regulatory Specialist I - Princess Margaret, Canada - University Health Network

University Health Network

Verified Company

Princess Margaret, Canada

2 weeks ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Full-time

Department: Research

Company Description:

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. 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.

Union:

Non-Union

Site:
Princess Margaret Cancer Centre

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

Reports to:
Clinical Research Manager, DMOH-CTG

Work Model:
On-Site

Grade:
N0:06

Hours:37.5 hours per week

Salary:
$64,974 - $81,218 annually: To commensurate with experience and consistent with UHN compensation policy

Shifts:
Monday - Friday

Status:
Permanent Full Time

Closing Date:
June 30, 2024

Position Summary & Duties

The Clinical Study and Regulatory Specialist I 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 I 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.

Qualifications:

At minimum, a completion of a Bachelor's degree program, or recognized equivalent in Health or Science-Related Discipline
At least one (1) year experience in the review and preparation of Health Canada and Research Ethics Board submissions, including writing informed consent forms
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
Satisfactory attendance
Certification as a Clinical Research Professional, preferred

Additional Information:

Why join UHN?

In addition to working alongside some of the most talented and inspiring healthcare professionals in the world, UHN offers a wide range of benefits, programs and perks.

It is the comprehensiveness of these offerings that makes it a differentiating factor, allowing you to find value where it matters most to you, now and throughout your career at UHN.

Competitive offer packages
Close access to Transit and UHN shuttle service
A flexible work environment
Opportunities for development and promotions within a large organization
Additional perks (multiple corporate discounts including: travel, restaurants, parking, phone plans, auto insurance discounts, onsite gyms, etc.)

Current UHN employees must have successfully completed their probationary period, have a good employee record along with satisfactory attendance in accordance with UHN's attendance management program, to be eligible for consideration.

UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.

**We thank all applicants for their interest, however, only those selected for further consideration will be contacted.