Regulatory Assistant, Clinical Trials
The Vancouver Prostate Centre (VPC) has an exciting career opportunity for a temporary, fulltime Regulatory Assistant interested in pursuing a role in clinical trials regulatory affairs.

POSITION SUMMARY

The Regulatory Assistant works closely with the Regulatory Affairs Coordinator and Clinical Trials Manager and provides assistance to the Clinical Trials Coordinators. The Regulatory Assistant provides a broad scope of administrative and data entry support to the Clinical Trials team.

MINIMUM QUALIFICATIONS

• Grade 12 plus additional relevant training such as a Medical Office Assistant (MOA) or Office Assistant certificate/diploma.
• Solid communication and interpersonal skills, with demonstrated experience communicating concepts in a professional manner.
• Ability to maintain confidentiality essential.
• Computer literate, including solid Microsoft Office skills and data entry experience.
• Demonstrated organizational skills.
• Demonstrated initiative.
• Strong attention to detail.
• Ability to work effectively both independently and as a member of a team.
• Relevant clinical trials experience and/or knowledge of relevant regulatory and ethical guidelines and principles for conducting research with human subjects is required. Additional training will be provided to the successful candidate.

RESPONSIBILITIES

Assist with day-to-day operations of assigned research studies, duties of which may include:

• Provides clerical support for data entry trials.
• Maintains study files by filing regulatory documents, Research Ethics Board (REB) submissions, acknowledgements, approvals and sending copies to the sponsor/coordinating centre as needed.
• Files/maintains correspondence files for all studies.
• Ensures Investigator and staff CVs are signed, filed in the master binder with copies in each study binder annually.
• Ensures medical license verifications are updated annually.
• Creates files for new studies.
• Updates staff training documents (binder and electronic files) and ensures that staff training is up to date.
• Assists with regulatory documents collection and submission for new studies.
• REB submissions such as acknowledgements, amendments and renewals.
• Assists with Clinical Trial Meetings.
• Performs additional duties and administrative tasks as required by the Regulatory Affairs Coordinator and Clinical Trials Manager.