Clinical Study Assistant II – Applied Health Research Centre, Observational Research Unit

Job title: Clinical Study Assistant II – Applied Health Research Centre, Observational Research Unit

Job description: The Applied Health Research Centre (AHRC) is an Academic Research Organization (ARO) at the Li Ka Shing Knowledge Institute of St. Michael’s Hospital in Toronto, with expertise in clinical study design, pragmatic methodology, and biostatistics. The AHRC has experience managing more than 200 multi-centre, national and international clinical trials, observational studies, and qualitative studies. It employs industry-leading web-based secure database technology, which incorporates advanced data validation and reporting tools. Over the past ten years, the AHRC has grown to be one of the largest AROs in Canada, and partners with diverse groups including the Toronto Academic Health Science Network (TAHSN), the Mayo Clinic, and the urban innovation hub MaRS.

The AHRC supports and manages all aspects of patient-centered clinical research including protocol development, study document development, clinical site management, clinical data management, data analysis and report writing. This position will offer the successful applicant a challenging and rewarding career in the clinical research area.

The primary role of the Clinical Study Assistant II is to support the Clinical Research Specialist in multi-centre clinical trial project coordination duties. The role will involve general study administrative support, meeting coordination for internal meetings as well as external Investigator training meetings, maintenance of the study master file, preparing and distributing study supplies, tracking study progress, preparing and distributing study newsletters, 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 I will report to the Manager, Observational Epidemiology and Qualitative Research Unit (OEQRU) and must be flexible to work beyond the job description at times as work demands.

DUTIES & RESPONSIBILITIES:

• Collecting and documenting study site information (contact info, administrative info, etc) as per SOPs, ICH/GCP
• Collecting and filing documents in the study master file as per SOPs, ICH/GCP
• Formatting study documents
• Assist with pre-hospital data abstraction as required
• Liaise with external partners for work with administrative datasets as required
• Managing/oversight of data management issues
• Reviewing study data for completeness, integrity
• Running automatic data reports and performing manual data review to identify data discrepancies and inconsistencies, and issuing data queries to the sites; following up on outstanding data queries; ensuring validation checks are run consistently across the sites/study
• Track site REB approvals and provide support as needed
• Assist with project-related meetings
• Work collaboratively with internal team members, external stakeholders, vendors and consultants
• Performing literature searches
• Assisting in grant preparation
• Other duties as assigned by the Clinical Research Specialist or Manager

QUALIFICATIONS:

• Bachelors Degree in a scientific discipline required
• Knowledge of health services research is preferred
• Emergency Medical Service (pre-hospital) health care experience and knowledge is preferred
• Paramedic training is an asset
• Knowledge of administrative datasets is an asset
• Excellent organizational skills
• Excellent communication skills
• Excellent interpersonal and writing skills

Company: St. Michael’s Hospital

Expected salary:

Location: Toronto, ON

Job date: Sat, 19 Jun 2021 22:15:12 GMT