Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

The Clinical Study and Regulatory Specialist participates in the coordination of clinical trials from protocol review and regulatory approval through to activation, follow up and trial closure. This position is an 19-month term, temporary full-time contract, with the possibility of renewal for additional years, subject to performance, funding availability, and program requirements.

Responsibilities

• Preparation of Health Canada and Research Ethics Board submissions
• Monitoring and promoting the quality and integrity of data and recording clinical trial data in case report forms (CRFs)
• Coordination and monitoring of data in accordance with the trial protocol, hospital and departmental guidelines and professional standards of practice
• Ensuring all data is complete, accurate, timely, and follows applicable ICH-GCP, FDA and US federal code and Tri-Council regulations
• Interpreting applicable regulations to ensure compliance
• Utilizing quality assurance procedures to ensure high quality data is obtained
• Executing study-related administrative tasks, such as maintenance and modification of study-specific trackers and study tools
• Collection and maintenance of regulatory documents, ethics submissions, protocols, staff training and delegation logs in paper and electronic formats

Requirements

• At minimum, a completion of a Bachelor’s degree program, or recognized equivalent in Health or Science-Related Discipline required
• At least two (2) year experience in some or all of Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects required
• 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 and 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
• 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.

Skills

• Health Canada submissions
• Research Ethics Board submissions
• Data monitoring
• Data integrity
• Clinical trial data recording
• Case report forms (CRFs)
• ICH-GCP
• FDA regulations
• US federal code
• Tri-Council regulations
• Regulatory compliance
• Quality assurance
• Study-specific trackers
• Study tools
• Regulatory documents
• Ethics submissions
• Staff training logs
• Delegation logs
• Written communication
• Verbal communication
• Organization
• Prioritization
• Computer skills
• Independent work
• Interpersonal skills
• Working under pressure
• Attention to detail
• Professionalism
• Courtesy
• High quality work
• Meeting deadlines
• Multiple concurrent task performance
• Legislative knowledge
• UHN policies
• Departmental policies
• Client service orientation
• Working with diversity

Location

• Princess Margaret Cancer Centre

Work Type

• Temporary Full-Time
• Contract

Experience Level

• 2 years experience in Oncology, Clinical trials, medical terminology, regulatory issues involving human subjects
• 1 year experience in the review and preparation of Health Canada and Research Ethics Board submissions

Education Level

• Bachelor’s degree program, or recognized equivalent in Health or Science-Related Discipline
• Certification as a Clinical Research Professional, preferred

Salary/Compensations

• $35.35 – $53.03 per hour

Benefits

• Competitive offer packages
• 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
• Multiple corporate discounts (travel, restaurants, parking, phone plans, auto insurance discounts, on-site gyms, etc.)

About the Company

• UHN is Canada’s #1 hospital and the world’s #1 publicly funded hospital.
• With 10 sites and more than 44,000 TeamUHN members, UHN consists of Toronto General Hospital, Toronto Western Hospital, Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, The Michener Institute of Education and West Park Healthcare Centre.
• As Canada's top research hospital, the scope of biomedical research and complexity of cases at UHN have made it a national and international source for discovery, education and patient care.
• UHN has the largest hospital-based research program in Canada, with major research in neurosciences, cardiology, transplantation, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine.
• UHN is a research hospital affiliated with the University of Toronto.
• UHN’s vision is to build A Healthier World and it’s only because of the talented and dedicated people who work here that we are continually bringing that vision closer to reality.

Equal Opportunity

• 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.