Research Ethics and Regulatory Coordinator (10577)

Overview

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Position summary

The Research Ethics Board & Regulatory Coordinator is responsible for day-to-day operations and support of the Oak Valley Health Research Ethics Board (OVH REB) and regulatory support to the Office of Research.

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Who you are

You encompass Oak Valley Health’s core values and live the words of respect, trust, commitment, compassion and courage. You are a patient and / or client centered individual who performs at an exemplary standard.

You are a team player with excellent communication, critical thinking and prioritization skills. 48 Scheduling Created with Sketch.

Schedule

Monday - Friday. Please note schedules may change due to operational needs. 48 Budget Created with Sketch.

Compensation

Hourly - $ - $ Annually - $75,543 - $97, 48 Innovation Created with Sketch.

Contract length

Full Time Temporary (approximately 1 year).

Responsibilities

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Support

The Research Ethics Board & Regulatory Coordinator will support audits and inspections as they incur at OVH and conduct quality assurance audits for OVH REB approved studies.

The successful candidate will also provide oversite support for research training compliance at OVH (, TCPS2, GCP, HCD5), create, manage, and oversee REB SOPs, guidance documents and policies, and attend various conferences, meetings, and workshops to represent the OVH REB.

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Consulting

The successful candidate will provide consultation to staff and researchers regarding the ethics review process and the required obligations according to institutional, national, and provincial requirements and guidelines.

This includes departmental educational support, education support to Board of Record sites, and creating quality reports and metrics.

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Performance

The Research Ethics Board & Regulatory Coordinator is responsible for facilitating and conducting reviews of research ethics submissions, providing recommendations, advice, and discussions for the OVH REB, in accordance with the regulations and guidelines governing human research participants protection.

The Research Ethics Board & Regulatory Coordinator will report to the Manager of Research and working closely in a liaison capacity to the Chair, Research Ethics Board.

Requirements

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Qualifications

Undergraduate degree or advanced diploma with experience in a research course or project involving human participants. Master's degree in a related field, is an asset.

2-3 years of Research ethics administration, coordination and experience with review of preparation of REB packages. Certification as a Clinical Research Professional is an asset (, CCRP).

Proficiency with Microsoft Office, including Excel and the ability to learn other applications. 48 Artificial Intelligence Created with Sketch.

Knowledge

Knowledge of the Tri-Council Policy Statement, the Canada Food and Drug Act, the ICH Good Clinical Practices, and other relevant provincial, national, and international regulations and current regulatory developments (TCPS2, GCP, Health Canada Division 5 training is required).

Strong understanding of research ethics approval through Clinical Trials Ontario and OCREB. Strong knowledge of clinical research terminology.

Familiarity with REDCap and creating metrics for reports. 48 Creative Created with Sketch.

Initiative

Flexible with superior organization skills and the ability to work efficiently to prioritize multiple, competing tasks in a fast-paced and dynamic environment.

Ability to exercise sound judgment and discretion, make decisions and take initiative while working with confidential patient information and responding to patient inquiries.

Self-motivated with an enthusiastic, positive attitude, and excellent multi-tasking ability. 48 Assessment Created with Sketch.

Skills

Strong attention to detail. Excellent written / verbal communication skills. Exceptional organizational, time management and problem-solving skills.

Exercises judgment and decision making, using established policies and procedures to resolve technical problems. Demonstrated understanding of policies, procedures, and issues dealing with research integrity and the conduct of research.

Excellent data collection and data entry skills required.