Clinical Research Analyst

University Health Network • Toronto, ON

3d • CA$43 • Onsite

About The Position

This clinical research position within the Ajmera Transplant Centre at Toronto General Hospital focusing on beta cell replacement therapies for the treatment of diabetes. Our portfolio includes translational and clinical research led by a multidisciplinary group of clinician scientists. Our focus on biomarkers and novel therapeutics for the treatment of diabetes makes this an exciting position for research personnel with basic/translational and clinical knowledge and interests. This position offers an exciting research opportunity for an extremely organized, highly motivated, detail-oriented and hard-working individual, who possesses strong communication and interpersonal skills, and will enjoy the challenge of learning from and working with an interdisciplinary research team.

Requirements

• BSc in Pharmaceutical Science or equivalent Canadian program, required
• 1 to 2 years clinical and/or professional experience
• Experience using Data Management (REDCap, MS Excel, Veeva Vault) and Statistical Analysis software (SAS or SPSS; GraphPad Prism) required
• ICH/GCP training required
• Experience in reviewing and writing SOPs
• Experience in clinical research/quality improvement is required: (e.g., study coordination; involvement/ management of randomized control trial studies; database design/set-up; data collection/management; reviewing and updating of standard operating procedures, questionnaire administration; data entry; literature searches, etc.)
• Strong organizational and problem-solving skills
• Excellent verbal and written communication skills. Candidates with fluency in multiple languages preferred.
• Highly motivated, with the ability to set priorities and work well independently and as part of a multidisciplinary team

Nice To Haves

• Previous experience using data management (e.g., Microsoft Office Access, Excel) and statistical analysis software (e.g., SAS or SPSS; SPSS) preferred

Responsibilities

• Collect, verify, and report clinical and pharmacologic research data in accordance with study protocols and institutional guidelines.
• Use knowledge of pharmaceutical science and pharmacologic mechanisms to understand and interpret study protocols and investigational therapies used in clinical research.
• Coordinate screening and recruitment of eligible research participants and obtain informed consent, explaining study procedures regarding investigational therapies, potential risks, and study procedures in accordance with ethical and regulatory requirements
• Ensure that informed consent documentation aligns with study requirements for investigational therapies and related biological sample collection.
• Assist with the processing and documentation of biological samples collected during research studies, including proper labeling, storage, and shipment for pharmacokinetic, stability, and biomarker analyses.
• Enters medical data from health records or other sources, as per approved study protocol and authorized access into electronic data capture (EDC) systems for example Redcap, Medidata, etc.
• Develop, review, and maintain study-specific SOPs including data management plans, data dictionaries, and monitoring plans to support standardized clinical research processes.
• Respond to sponsor data queries and work with investigators, research staff, and external collaborators to resolve discrepancies in study data
• Supports the reporting of events to Research Ethics Board as needed (Privacy incidents and Serious Adverse Events (SAE))
• Prepare and submit regulatory documentation (amendments, reportable events, annual renewals, study closures) to Research Ethics Board (REB)
• Executes study-related administrative tasks, such as collection and maintenance of regulatory documents, ethics submissions, protocols, staff training and delegation logs in paper and electronic format

Benefits

• Competitive offer packages
• Government organization and a member of the Healthcare of Ontario Pension Plan (HOOPP https://hoopp.com/)
• 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.)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level