Clinical Study Assistant Ii Ahrc Obs Research Unit

8 months ago

Toronto, Canada Unity Health Toronto Full time

The Applied Health Research Centre (AHRC) at St. Michael¿s Hospital is currently seeking a Clinical Study Assistant II. The Clinical Study Assistant II will report directly to the Manager, Observational Epidemiology and Qualitative Research Unit (OEQRU), and will support research studies managed by the OEQRU.

The primary role of the Clinical Study Assistant II is to support the Clinical Research Specialist (Project Manager) in multi-centre study coordination duties. The role will involve general study administrative support, coordination of study related meetings, maintenance of the study master file, preparing and distributing study supplies, tracking study progress, preparing and distributing study newsletters, collecting data and interacting with study participants, reviewing study data and performing data validation activities (running validation reports, manual data review and issuing data queries), and communicating with the internal study team, study sponsor, vendors, and sites. The successful applicant will work closely with investigators, study team members, study coordinators, sponsors and vendors. The Clinical Study Assistant II must be flexible to work beyond the job description at times, as work demands.

DUTIES & RESPONSIBILITIES:
- Collecting and filing documents in the study master file as per SOPs, ICH/GCP- Managing/oversight of the study master file- Formatting study documents- Collecting data from English and French-speaking study participants via telephone-administered questionnaires- Labeling, distributing and tracking study supplies to clinical sites- Preparation and distribution of study newsletters on a regular basis- Administration/coordination of study meetings, including taking minutes- Managing/oversight of data management issues- Reviewing study data for completeness, integrity- Data entry, as required- Creating and maintaining spreadsheets to support study activities- Performing literature searches- Other duties as assigned by the Clinical Research Specialist or Manager

QUALIFICATIONS:
- A BSc in a science or health-related discipline, or demonstrable equivalent combination of specialized education and experience- Bilingual preferred (English/French)- Training in ICH/GCP and/or CCRP accreditation would be an asset- Knowledge of medical/scientific terminology- Proficiency in MS Office tools (MS Word, Excel, PowerPoint) an asset- Excellent organizational skills- Excellent attention to detail- Excellent communication skills (verbal and written)- Excellent interpersonal skills- Individual must be goal and team oriented

**Thank you for applying.

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