Research Assistant

3 weeks ago

Toronto, Canada Sunnybrook Health Sciences Centre Full time

37.5 hours work week, with some flexibility based on patient and/or surgeon schedules, and the ability to work after hours as needed.

The Sunnybrook Research Institute is seeking a Temporary, Full-time research assistant to ensure the smooth and efficient day-to-day operation of research activities within the Department of Otolaryngology at Sunnybrook Health Sciences Centre. The successful incumbent will be responsible for daily administrative and clinical research tasks specifically within the Cochlear Implant Program, and other general Otology-related research. The coordinator will work collaboratively with physicians, clinical personnel, and external sponsors and provide support to other staff as required.

**Responsibilities include but are not limited to**:

- Data Management:

- Maintain study databases, and reliably enter study data into these databases in a timely manner
- Ensure integrity of research data collected
- Plan, implement, and coordinate all aspects of data collection and source documentation such as questionnaires, surveys, and structured patient interviews
- To liaise with all stakeholders to modify data collection instruments, produce reports and help with data extraction.
- Oversight for all aspects of data collection and source documentation as per ICH/GCP guidelines
- Research Coordination:

- Overseeing the day-to-day operations of a number of concurrent simple and complex research studies, including investigator-initiated and sponsor-initiated clinical trials
- Maintaining contact with study participants to address and follow-up on their research-related inquiries
- Conducting study visits with patient research participants
- Communicate study procedures to physicians, clinical and research personnel, and provide updates and support to other staff as required
- Prepare and organize materials (e.g. documents, kits, folders, study binders) for ongoing patient follow up study visits, ensure research study documents are up to date for clinical department and study team use
- Regulatory/Administrative responsibilities:

- Ensure that all aspects of studies are performed within International Conference on Harmonization (ICH), Good Clinical Practice (GCP) and Tri-Council guidelines, and ensure compliance with SHSC Standard Operating Procedures (SOPs) for clinical trials conduct
- Prepare REB and regulatory submissions
- Liaise with legal department to finalize research contracts and process CTA/NDA/LOI/FDFs for clinical trials as needed
- Liaise with the Centre for Clinical Trial Support to initiate new clinical trials and ensure ongoing trials meet all regulatory standards
- Correspond with PI, sponsors, REB, regulatory agencies as needed and document all correspondence in a clear, concise and timely fashion
- Maintain trial related documents or study monitor visits in regulatory/study binder ensuring accuracy and completeness, including but not limited to source documentation, case report forms, charts, remote data entry, certifications, screening logs, and drug or device accountability logs
- Ensure appropriate study close-out, including archiving and document storage and security
- Ensure that site personnel complete and document protocol-specific training (i.e., scales, assessments, eCRF training modules, GCP certification/re-certification)
- Submit study expenses to finance department and follow up on any outstanding invoices as needed

**Skills and Qualifications**
- Undergraduate Degree (Science or Arts) is required; a Master’s Degree is preferred
- Evidence of training certification in Tri-Council Policy Statement -2 (TCPS-2) and the International Conference on Harmonization - Good Clinical Practice Guidelines (ICH-GCP).
- Certification as a Clinical Research Professional (CCRP) or Clinical Research Coordinator (CCRC) is an asset
- Minimum 2 years of experience coordinating research in an academic department, research institute or organization is required
- Experience coordinating regulated clinical trials
- Excellent project management skills, with the ability to prioritize workload and manage multiple projects with tight timelines simultaneously
- Demonstrated analytical skills and familiarity with qualitative and/or quantitative research methods
- In depth knowledge of Personal Health Information Protection Act (PHIPA), Health Canada & Food and Drug Administration (FDA) regulations is preferred
- Outstanding oral, written and communication skills are required to help in the development of protocols, PowerPoint presentations, posters, and manuscripts for conferences, as needed

In accordance with Canadian Employment and Immigration guidelines, applicants must be eligible to work in Canada. 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

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