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Clinical Research Coordinator Ii
3 months ago
Job Posting #: 923617
Position:
Clinical Research Coordinator II
Union:
Non-Union
Site:
Toronto General Hospital Research Institute
Department:
Medicine-Cardiology
Reports to:
Clinical Research Manager, CTTU, PMCC
Hours: 37.5 per week
Salary:
$71,643 to $89,544 per annum (Commensurate with experience and consistent with the UHN Compensation Policy)
Status:
Permanent Full-time
Shifts:
Day
Posted Date:
August 16, 2023
Closing Date:
September 16, 2023
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.Position Summary and Duties
The
CRC II reports to the Clinical Research Manager of the CTTU and will draw upon their experience as a research professional to play a pivotal role in the implementation of CTTU's strategic objectives, including quality assurance and financial oversight.
Additionally, CRC II will assume responsibility for the coordination of certain clinical research studies and projects undertaken by PMCC investigators.
Responsibilities of the Clinical Research Coordinator II (CRC II) include but are not limited to the following:- Conducting and leading quality assurance, regulatory compliance and oversight activities, including participation in internal and external monitoring (and audits);
- Assist program manager in clinical trial budgeting, study financial reconciliation, contract negotiations and financial oversight;
- Provide direct and functional supervision of assigned personnel (including students) for one or more studies/assignments;
- Assist CTTU manager in onboarding new staff and track staff training;
- Contribute towards development of guidelines, procedures, and standards;
- Develop and lead process improvement initiatives based on project management principles and for improving research operations;
- Recruitment of study participants (e.g. identifying, screening potential participants and obtaining informed consent);
- Executing/coordinating all aspects of patient study visits as per study protocol (e.g. source documentation including adverse events and medications, administration of questionnaires, sample processing and shipping, etc.);
- Implementing and coordinating all aspects of data management including data collection, data entry into CRFs, and source documentation, as per UHN policy and ICH/GCP guidelines;
- Execution of studyrelated administrative tasks;
- Reviewing and assessing studyrelated documents;
- Prepare study status reports for investigators and CTTU management;
- Submissions to the Research Ethics Board and other regulatory agencies as required;
- Liaising with sponsors, external stakeholders and members of the clinical care team.
Qualifications
- At minimum Bachelor's degree, or recognized equivalent, in a health or sciencerelated discipline
- Minimum 3 years clinical research experience
- Experience conducting quality assurance and regulatory oversight activities is required
- Demonstrable experience in preparing clinical trial budgets, contract negotiation and financial tracking is required
- Recognized certification in clinical research (through ACRP or SoCRA e.g. CCRP)
- Recognized qualification and/or certification in project management (e.g. PMI) will be an asset
- Cardiology experience in a clinical/research will be an asset
- Knowledge of investigatordriven research processes, budgeting, contract review and mandatory reporting
- TDG (Transportation of Dangerous Goods) certification preferred
- Knowledge of IATA (International Air Transport Association) shipping regulations and basic laboratory procedures an asset
- Develops and presents material for publication using strong written, verbal and graphical communications skills
- Excellent written and verbal communication skills
- Excellent interpersonal and customer service skills
- Strong organizational and time management skills
- Ability to work well independently as well as part of a team; selfmotivated
- Strong analytical and problem solving skills
- Proficiency with MS Office software (Outlook, Word, Excel, PowerPoint)
- 35 years clinical and/or professional experience
- Knowledge of research
