This position has a term length of 1 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.
Responsibilities
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
Qualifications
- 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 a comprehensive benefits package.
The University of Alberta, its buildings, labs and research stations are primarily located on the territory of Néhiyaw (Cree), Niitsitapi (Blackfoot), Métis, Nakoda (Stoney), Dene, Haudenosaunee (Iroquois) and Anishinaabe (Ojibway/Saulteaux), lands that are now known as part of Treaties 6, 7 and 8 and homeland of the Métis. The University of Alberta respects the sovereignty, lands, histories, languages, knowledge systems and cultures of all First Nations, Métis, and Inuit.
The University of Alberta is a community of knowledge seekers, change makers and world shapers who lead with purpose each and every day. We are home to over 14,000 faculty and staff, more than 40,000 students and a growing community of 300,000 alumni worldwide.
Your work will have a meaningful influence on a fascinating cross-section of people - from our students and community members, to our renowned researchers and innovators, making discoveries and generating solutions that make the world healthier, safer, stronger and more just. Learn more.
At the University of Alberta, we are committed to creating an inclusive and accessible hiring process for all candidates. If you require accommodations to participate in the interview process, please let us know at the time of booking your interview and we will make every effort to accommodate your needs.
We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.
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The University of Alberta is committed to creating a university community where everyone feels valued, barriers to success are removed, and thriving connections are fostered. We welcome applications from all qualified persons. We encourage women, First Nations, Métis and Inuit persons, members of visible minority groups, persons with disabilities, persons of any sexual orientation or gender identity and expression, and all those who may contribute to the further diversification of ideas and the University to apply.
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