Clinical Research Coordinator

3 weeks ago

Toronto, Canada Sunnybrook Health Sciences Centre Full time

**Clinical Research Coordinator, Sunnybrook Research Institute**

**Location**:
Sunnybrook Health Science Centre (2075 Bayview Avenue, Toronto, Ontario)

**Reports to**:
Dr. Mario Masellis

**Hours**:
Typical 37.5 hour work week, with some flexibility based on patient schedules. Work must be done on-site.

**Status**:
Temporary Full-time (1 year term; renewable)

**Description**

The Sunnybrook Cognitive & Movement Disorders Clinic in conjunction with the L.C. Campbell Cognitive Neurology Research Unit are seeking an energetic, highly motivated individual to work as a Clinical Research Coordinator responsible for recruitment and coordination of clinical trials testing new therapies and interventions for dementia prevention and treatment.

Excellent communication skills and the ability to understand and navigate the dynamics and subtleties of clinical trials is a must. If you are quality focused, highly skilled at problem solving, a self-starter, and enjoy working in a challenging and fast-paced environment, this position is for you.

**Key Responsibilities**:

- Manage research activities for industry-sponsored clinical trials, including study start up, recruitment, conduct, and closeout, and tracking study timelines/milestones
- Administer study tests and questionnaires
- Coordinate with team members (research nurses, cognitive raters, investigators, imaging techs) to schedule participant visits
- Process blood, CSF, and urine samples according to study protocols and ship samples out
- Complete blood draws, infusions, vital signs
- Document adverse events, serious adverse events, and protocol deviations, communicating reportable events to the CRO, sponsor and/or REB in a timely manner
- Order and track study supplies, ensuring there is a sufficient supply on hand for participant visits
- Be the primary point-of-contact for sponsor, CRO, participants, and study team.
- Prepare documents required for REB submissions and maintain REB approvals
- Manage study budgets and invoicing, facilitate contracts and agreements, prepare reports
- Communicate reportable events to the CRO/sponsor and REB in a timely manner
- Assist Principal Investigator in the initiation of new research, and interpretation and implementation of study protocols.
- Promote a cross-functional approach with other research facilities within the hospital (pharmacy, biobank, laboratory, imaging)
- Prepare and maintain all administrative and regulatory documents to facilitate milestones from study start-up to close-out; maintain all study documentation according to applicable guidelines.
- Review medical charts to identify potential participants and collect clinical information needed for study purposes
- Conduct training sessions for research team and investigators as needed.
- Assist in developing and implementing policies, procedures and standards relative to all aspects of the research study program.
- Present study progress reports to Principal Investigator and assist in setting project/study goals.

**Qualifications/Special Skills include**:

- Minimum of Bachelor's Degree in health-related field or equivalent (e.g., Sc.N. preferred)
- Minimum 1 year demonstrated research experience in HC Division 5 clinical trials, including in-depth knowledge of ICH/GCP, PHIPA, TCPS, Health Canada and FDA regulations.
- CCRP or CCRC certification is a strong asset
- Understanding of project management processes and methodology is an asset.
- Experience with financial management of research studies is an asset
- Proficient oral and written communication skills are required
- Excellent organizational and time management skills are required
- Professional and courteous manner are required
- A “can do” attitude: willing and able to work in a complex environment with multiple recruitment demands, priority deadlines, and occasionally stressful emergency response conditions.
- Autonomous clinical critical thinking ability

Sunnybrook Research Institute is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). If you require accommodation for disability during any stage of the recruitment process, please indicate this in your cover letter.

Sunnybrook Research Institute is strongly committed to inclusion and diversity within its community and welcomes all applicants including but not limited to: visible minorities, all religions and ethnicities, persons with disabilities, LGBTQ persons, and all others who may contribute to the further diversification of ideas.

Please be advised that in order to be eligible for employment at Sunnybrook, all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada (e.g., two doses of a two-dose vaccine series, or one dose of a single-dose vaccine series); **AND** have received the final dose of the COVID-19 vaccine at least 14 days ago. Medical exemptions or any other

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