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

St. Boniface Hospital is committed to empowering a workforce that welcomes and celebrates diversity by fostering culturally safe places for all employees. We strive to celebrate our diverse workforce and the outstanding work we do every day.