Officer - Research Supports and Grants

Position Overview

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 6666666666institutional 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.

Experience

• 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.
• Project management experience an asset.
• Demonstrated experience in the development of educational materials and manuals for clinical researchers, students, residents and fellows, required.

Education (Degree/Diploma/Certificate)

• Undergraduate or graduate degree from a recognized university in an appropriate health related discipline.
• An equivalent combination of education, training and experience may be considered.

Certification/Licensure/Registration

Not Applicable

Qualifications and Skills

• 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.

Physical Requirements

Not Applicable