Research Regulatory Coordinator

2 weeks ago


Vancouver, Canada GI Research Institute Full time

**Key Responsibilities**:

- Prepares and/or oversees the preparation of regulatory submissions which requires interaction with sponsors and Clinical Research Organizations
- Responsible for the management of Investigator Site Files (ISF) and documents related to regulatory submissions
- Maintains current knowledge of regulatory requirements, including ICH-GCP, FDA, and Health Canada guidelines
- Communicates changes in regulatory information to study coordinators in a timely manner
- Responsible for negotiating budgets and managing Clinical Trial Agreements
- Assists in developing Standard Operating Procedures, and ensures staff training is documented
- Reports to Clinical Research Manager

**Required Qualifications**:

- Minimum BA/BSc, Life Science, or related field of study
- Experience in Regulatory Affairs/Clinical Research an asset
- Strong organizational skills
- Ability to prioritize and perform multiple tasks efficiently
- Requires knowledge and understanding of the North American regulations/guidelines
- Good communication skills and values teamwork

**Company Profile**:
G.I.R.I. is an independent non-profit organization based in Vancouver, British Columbia. It consists of a team of gastroenterologists, nurses, and support staff. It houses an infusion room and endoscopy unit. G.I.R.I. actively participates in clinical trials to enhance treatment options for patients with gastrointestinal disorders. It contributes to patient health and well-being by providing the best care through integrated clinical practice, education, and research.

**Salary**:
Commensurate with experience.

**Job Types**: Full-time, Permanent

**Salary**: From $25.00 per hour

**Benefits**:

- Dental care
- Disability insurance
- Extended health care
- Life insurance
- Paid time off
- Vision care

Schedule:

- 8 hour shift
- Monday to Friday

Work Location: Hybrid remote in Vancouver, BC

Expected start date: 2023-08-14



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