Research Coordinator - Toronto, Canada - Sunnybrook Health Sciences Centre

Sunnybrook Health Sciences Centre

Verified Company

Toronto, Canada

1 week ago

Posted by:

Sophia Lee

beBee Recruiter

Description

Research Coordinator, Sunnybrook Research Institute
Temporary Full-time, 1 year term with an option to renew

The Sunnybrook Research Institute is seeking a Temporary, Full-time Research Coordinator 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.

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

Responsibilities include but are not limited to:

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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
Liaise with all stakeholders to modify data collection instruments, produce reports and help with data extraction.
Oversee all aspects of data collection and source documentation as per ICH/GCP guidelines

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Research Coordination:

Oversee the daytoday operations of a number of concurrent simple and complex research studies, including investigatorinitiated and sponsorinitiated clinical trials
Maintaining contact with study participants to address and followup on their researchrelated inquiries
Conduct 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, ensuring research study documents are up to date for clinical department and study team use

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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 the legal department to finalize research contracts and process CTA/NDA/LOI/FDF's 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 PIs, 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 closeout, including archiving, document storage and security
Ensure that site personnel complete and document protocolspecific training (i.e., scales, assessments, eCRF training modules, GCP certification/recertification)
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 (TCPS2) 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

**Please be advised that in order to be eligible for employment at Sunnybrook Health Sciences Centre, all new hires must have received the full series of a COVID-19 vaccine or combination of COVID-19 vaccines approved by Health Canada AND have received the final dose of