Clinical Study and Regulatory Specialist I

University Health Network; Old Toronto; Hybrid; CAD 66,000 - 84,000; Full time

Job summary

An established industry player in healthcare is seeking a Clinical Study and Regulatory Specialist I to join their dynamic team. This exciting role involves coordinating clinical trials, ensuring data integrity, and navigating regulatory compliance in a collaborative environment. With a focus on innovative drug studies, the position offers a unique opportunity to contribute to groundbreaking research while working alongside some of the most talented professionals in the field. The organization promotes a flexible hybrid work model and provides numerous benefits, making it an ideal place for those looking to advance their careers in clinical research.

Benefits

Competitive Offer Packages

Healthcare of Ontario Pension Plan (HOOPP)

Close Access to Transit

Flexible Work Environment

Opportunities for Development and Promotions

Corporate Discounts

On-site Gyms

Qualifications

• Bachelor’s degree in Health or Science required.
• 2+ years experience in Oncology and clinical trials preferred.

Responsibilities

• Coordinate clinical trials from protocol review to trial closure.
• Ensure compliance with ICH-GCP, FDA regulations.

Skills

Clinical Trials Coordination

Data Monitoring

Regulatory Compliance

Oncology Knowledge

Excellent Communication Skills

Organizational Skills

Attention to Detail

Interpersonal Skills

Client Service Orientation

Education

Bachelor's Degree in Health or Science

Tools

eCRFs

CTCAE

REB Submissions

Job description

Clinical Study and Regulatory Specialist I

• Full-time
• Department: Research

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 ground-breaking firsts and a purpose of “Transforming lives and communities through excellence in care, discovery and learning”, UHN 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: Drug Development Program, Phase I
Reports to: Clinical Research Manager
Work Model: Hybrid
Grade: N0:06
Hours: 37.5 hours per week
Salary: $66,924 - $83,655 annually (To Commensurate with experience and consistent with UHN compensation policy)
Status: Permanent Full-time
Closing Date: December 31, 2024

Position Summary
The Drug Development Program at Princess Margaret Hospital is the largest drug development program in Canada and the only centre outside of the United States to have a contract with the National Institutes of Health (NIH) for Early Phase Therapeutic studies. The Drug Development Program includes a Phase I program, focusing on studies of innovative drugs and immunotherapy, with a strong emphasis on pharmacokinetics and correlative studies. It involves a collaborative and multidisciplinary approach and is strategically designed to ensure the rapid completion of high-quality studies.

This role will work in a hybrid office environment – the candidate will have the opportunity to work from home and will also have a workspace on site. The Clinical Study and Regulatory Specialist I participates in the coordination of clinical trials from protocol review and approval through to activation, follow-up, and trial closure.

Duties

• Monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRFs). The coordination and monitoring of data is performed in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice.
• All data must be complete, accurate, timely, and must follow 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 to ensure compliance. Quality assurance procedures are utilized to ensure high-quality data is obtained.

Minimum Requirements

• Completion of a Bachelor’s degree program, or recognized equivalent in Health or Science related discipline.
• At least two (2) years of experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects.
• Working knowledge of CTCAE, electronic case report forms (eCRFs), REB submissions, and ICF amendments are assets.
• 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 with 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.

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.
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP).
• 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, on-site gyms, etc.).

All applications must be submitted before the posting close date.

UHN uses email to communicate with selected candidates. Please ensure you check your email regularly.

Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading, inaccurate, or incorrect, UHN reserves the right to discontinue with the consideration of their application.

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.