Officer - Research Supports and Grants

Winnipeg Regional Health AuthorityWinnipeg, MB
Onsite

About The Position

Under the general direction of the Administration Manager, Office of Clinical Research, and while demonstrating a commitment to the Mission, Values and Management Philosophy of St. Boniface Hospital, the Research Support and Grants Officer, Office of Clinical Research is responsible for: assisting with the development of academic research studies; working with Investigators to develop and submit research projects for regulatory, Research Ethics Board and Research Review Committee approval; assisting with the development of continuing education programs for research; assisting with the development of institutional research policies and procedures; conducts Good Clinical Practice monitoring or auditing of clinical research studies; providing administrative support to the Research Review Committee and performing other related duties as required.

Requirements

  • Three (3) to five (5) years’ experience in clinical research (both academic and industry related) required.
  • Two (2) years’ experience with submissions of Clinical Trial Applications to Health Canada and submissions to a Research Ethics Board as well as institutional committees.
  • Recent regulatory, quality control and quality assurance experience in academic or industry required.
  • Previous experience in clinical trial monitoring and auditing required.
  • Demonstrated experience in the development of educational materials and manuals for clinical researchers, students, residents and fellows, required.
  • In-depth knowledge and understanding of regulatory requirements and processes for therapeutic product development and approval in Canada and the United States required.
  • In-depth knowledge and understanding of regulatory requirements and processes for Clinical Trials in Canada and the United States required.
  • In-depth knowledge of ethics requirements for the conduct of clinical research required.
  • Knowledge of the pharmaceutical industry required.
  • Familiarity with governing regulatory agencies (Health Canada and US FDA) required.
  • Excellent verbal and written communication skills.
  • Good planning and problem-solving skills.
  • Excellent interpersonal skills.
  • Ability to work both independently and in teams.
  • Ability to work under pressure and handle conflicting priorities and deadlines.
  • Very detail oriented.

Nice To Haves

  • Project management experience an asset.

Responsibilities

  • Assisting with the development of academic research studies
  • Working with Investigators to develop and submit research projects for regulatory, Research Ethics Board and Research Review Committee approval
  • Assisting with the development of continuing education programs for research
  • Assisting with the development of institutional research policies and procedures
  • Conducts Good Clinical Practice monitoring or auditing of clinical research studies
  • Providing administrative support to the Research Review Committee
  • Performing other related duties as required
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