Administrative Assistant Clinical Trials

This position has a term length of1 year plus 1 day with the possibility of extension.

Location - This role is in-person at North Campus Edmonton.

This position is responsible for assisting the Gastroenterology research group with core administrative tasks relating to all administrative aspects of conducting clinical trials in gastroenterology. Under the supervision of Dr Frank Hoentjen the Administrative Assistant will provide day-to-day administrative support to the study team staff.

Specific responsibilities include regulatory & documentation administration ongoing study maintenance scheduling monitoring visits study closeout and archiving and administrative and operational support.

Regulatory & Documentation Management

• Maintain and organize regulatory binders and essential study documents.
• Ensure all regulatory documentation is current accurate and audit-ready.
• Track and ensure completion of required certifications (e.g. GCP CPR and annual CV updates for study staff).

Study Start-Up (Sponsor Package Focus)

• Ensure all required site documentation is completed collected and returned to the sponsor/CRO in a timely manner.
• Coordinate internal site readiness activities including document collection and organization.
• File and maintain all start-up documentation within regulatory binders.
  

Ongoing Study Maintenance

• Maintain ongoing communication with sponsors/CROs on behalf of the site for document reconciliation.
• Ensure regulatory documents remain up to date throughout the study.

Monitoring Visits & Communication

• Schedule and coordinate monitoring visits audits and site visits.
• Prepare and maintain documentation required for monitoring visits.
• Organize and set up meetings (including virtual meetings via Microsoft Teams).
• Act as a point of contact for sponsor document requests.

Study Closeout & Archiving

• Assist with study closeout activities including document reconciliation and completion of required checklists.
• Ensure proper archiving of study files in accordance with institutional and regulatory requirements.

Administrative & Operational Support

• Provide administrative and coordination support to the research team including overflow supervisory tasks as needed.
• Maintain internal tracking systems and logs to support study operations.
• Assist with workflow coordination across multiple studies and priorities.

• Minimum education: High School diploma
• Minimum of 2 years working in an academic clinic research setting.
• Experience working in an academic or research setting is preferred.
• Experience in working with multi-disciplinary groups.
• Proficiency in Microsoft Office and trial portals.
• Problem solving communication (oral and written) interpersonal and organizational skills.
• High level of accuracy and attention to detail required.
• Commitment to providing timely and efficient service.
• Knowledge of the research policies procedures and guidelines for the major CROs and partners is preferred.
• Demonstrated competencies in the areas of professionalism results orientation organizational
  understanding teamwork flexibility and adaptability.

Application Instructions

Click Apply Now to submit your resume and cover letter.

This position is subject to all applicable terms and conditions of the collective agreement between the Governors of the University of Alberta and the Non-Academic Staff Association (NASA).

This position offers acomprehensive benefits package.