Regulatory Coordinator

Hamilton Health Sciences•Hamilton, ON

About The Position

The Regulatory Coordinator supports the research team by providing research ethics and regulatory expertise for academic and pharmaceutical sponsored clinical trials. The Regulatory Coordinator is the main point of contact for external sponsors and is responsible for management of information and correspondence between the sponsor, the research team and the local and provincial research ethics boards (REB). Primary duties of this role include: Revising informed consent forms and other patient facing materials; creation of Letters of Information to capture changes following the relevant REB consent form templates; ongoing submission of protocols and other required regulatory documents including those relating to protocol amendments/revisions, safety information, annual ethics renewal and study completion reports. This role is pivotal for ensuring all regulatory correspondence and documents are maintained in a tracking system and organizes and maintains department regulatory files. Further responsibilities include quality oversight for audits and functions within the trial activation team by providing support for preparation and distribution of studies to the Protocol Review Committee (PRC), recording minutes, and communication of required actions to the research team. The Regulatory Coordinator will also assist Program Head and leadership team as required and will performs other duties and activities as assigned.

Requirements

Medical terminology required
Up to 2 years related experience required
General knowledge of research regulations and guidelines, such as ICH GCP Guidelines, Health Canada Food and Drug Regulations, Tri-Council Policy Statement (TCPS-2)
Demonstrated understanding of the REB’s role in protecting the rights, safety and wellbeing of research participants
Highly proficient computer skills and understanding of Microsoft Office applications
Attentive to detail with good analytical thinking and problem solving skills
Excellent written and verbal communication skills
Ability to work independently and within a team
Proficient time management and organizational skills
Ability to work under pressure to meet deadlines

Nice To Haves

2 year community college diploma with a Bachelor’s degree in health or science related field preferred
Clinical Research Graduate Certificate preferred
Current certification as a Clinical Resesrach Profeessional (SoCRA or ACRP) an asset
Clinical research experience preferred
Previous experience with ethics submissions preferred
Experience using data management software applications and/or clinical trial management systems preferred
An equivalent combination of education and experience may be considered

Responsibilities

Revising informed consent forms and other patient facing materials
Creation of Letters of Information to capture changes following the relevant REB consent form templates
Ongoing submission of protocols and other required regulatory documents including those relating to protocol amendments/revisions, safety information, annual ethics renewal and study completion reports
Ensuring all regulatory correspondence and documents are maintained in a tracking system
Organizing and maintaining department regulatory files
Quality oversight for audits and functions within the trial activation team
Providing support for preparation and distribution of studies to the Protocol Review Committee (PRC)
Recording minutes
Communication of required actions to the research team
Assisting Program Head and leadership team as required
Performing other duties and activities as assigned