Research Administrator

This position has a term length of1 year plus 1 day.

Location - This role is in-person. Work primarily takes place at North Campus Edmonton.

This position is responsible for assisting the Dr. Frank Hoentjen within the division of Gastroenterology in all administrative aspects of conducting clinical trials in gastroenterology. Under his supervision the Research Administrator will provide day-to-day independent administrative support to the division and
trial PIs.

Specific responsibilities include providing oversight while working closely with the Administrative Assistant in all areas of the regulatory & documentation management study start-ups ongoing study maintenance monitoring visits and coordination study closeout and archiving and administrative and operational support.

Key Responsibilities:

Regulatory & Documentation Management

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

Study Start-Up (Sponsor Package Focus)

• Review and process sponsor-provided start-up packages and essential documents.
• 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

• Independently organize 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).
• Responsible for independently communicating with sponsors ethics committee and finance Department to ensuring flow of information and avoidance of issues for the Project/Study.
• Act as a point of contact for sponsor document requests.

Study Closeout & Archiving

• Responsible for independently performing study closeout activities including document reconciliation and completion of required checklists.
• Responsible for ensuring 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: Post-secondary education including a diploma or Bachelor of Science in Nursing.
• Minimum of 2 years of administrative research experience (emphasis on gastroenterology
  preferred).
• Experience working in an academic or research setting is required.
• Experience working with multidisciplinary 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.
• 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.