Clinical Study and Regulatory Assistant Intern

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 ground breaking 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.

Job Description

ONLY FOR CURRENT SENECA STUDENTS FOR FALL 2024 (apply on Seneca Works and this UHN Careers portals). Please do NOT apply unless a current Seneca College student.

Union : Non-Union

Site : Princess Margarete Cancer Centre

Department : Drug Development Program - Phase I

Reports to : Clinical Research Manager

Work Model : On-Site

Grade : B0 : 90

Hours : hours per week

Salary : $ per hour : To commensurate with experience and consistent with UHN compensation policy

Shifts : Monday - Friday

Status : Temporary Full-Time

Closing Date : July 18, 2024, 11 : 59pm

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.

Duties

• Scanning source documents
• Archiving clinical trial materials
• Working closely with a multidisciplinary team across the Drug Development Program - Phase I (DDP1) and possibly, the Tumor Immunotherapy Program (TIP)
• Assist in coordinating clinical trials from startup to study activation, including but not limited to data entry and query resolution
• Executing study-related administration tasks, such as collection, scanning, organizing, and creation of regulatory documents
• Tracking clinical trial materials
• Drafting and submitting research ethics or institutional approval applications, such as amendments, renewals and study closures to Research Ethics Board (REB), dependent on team's current needs

Qualifications

• Completion of a Bachelor’s degree program, or recognized equivalent in Health or Science Related Discipline
• Currently enrolled in a diploma, degree, or graduate certificate program at Seneca College, preferably the Clinical Research Program
• Experience in drafting and submitting protocol and ICF amendments to REB preferred
• Experience in adopting a country-specific ICF into an institutional ICF template preferred
• Experience in initial trial submissions preferred
• Proficiency with MS Office software
• Understanding of some medical terminology
• Knowledge of clinical research and of human research regulations and guidelines including ICH / GCP, Tri-Council Policy, Declaration of Helsinki, Health Canada TPD and UHN policies
• Excellent judgment, professionalism, tact and diplomacy to work with diverse teams, all levels of leadership, and internal and external stakeholders
• Strong communication, organizational, time management and problem-solving skills
• Ability to prioritize workload and work effectively under pressure
• Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to UHN standards
• Previous research experience is considered an asset

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
• 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.)

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.

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.

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire.

Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN’s mandatory Vaccination Policy that is in effect.

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.

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.

All UHN Employees are required to be fully vaccinated with a COVID-19 vaccine series, approved by Health Canada or the World Health Organization, as a condition of hire.

Proof of COVID-19 vaccination will be required. Should you be the successful candidate, you will be required to comply with UHN’s mandatory Vaccination Policy that is in effect.

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.