Administrative Assistant - Clinical Trials

Job summary

The Administrative Assistant will provide operational and regulatory support to the gastroenterology research team, including managing study documentation and coordinating monitoring visits. They are responsible for ensuring all regulatory binders are audit-ready and assisting with study start-up and closeout activities.

Job details

This position has a term length of 1 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. RESPONSIBILITIES 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. QUALIFICATIONS * 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 a comprehensive benefits package [https://www.ualberta.ca/en/human-resources-health-safety-environment/benefits-and-pay/benefits-and-pension/benefits-overview/index.html]. 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 [https://www.ualberta.ca/en/careers.html]. 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. All University employees have a responsibility to foster a workplace that prioritizes safety in all its forms—physical, cultural, and psychological. This is achieved by promoting a safe environment, adhering to all safety laws, policies and procedures, completing all required safety training, identifying hazards and implementing controls, reporting incidents, and contributing to a culture of belonging and respect, while endeavoring to ensure that all colleagues feel valued and safe to express their thoughts, perspectives and concerns. 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. L’Université de l’Alberta s’engage à créer une communauté universitaire où chaque personne se sent valorisée, où les obstacles à la réussite sont éliminés et où des connexions enrichissantes peuvent se développer. Nous accueillons les demandes de toutes les personnes qualifiées. Nous encourageons les femmes; Premières nations, Métis et Inuits; membres des groupes minoritaires visibles; personnes handicapées; personnes de toute orientation sexuelle ou identité et expression de genre; et toutes les personnes qui peuvent contribuer à la diversification des idées et à l'université à postuler. The Faculty of Medicine & Dentistry [https://www.ualberta.ca/en/medicine/index.html] is one of the world’s top academic health science centres. With 21 departments, multiple research institutes and centres, and a focus on excellence in education, research, and clinical care, the faculty trains outstanding medical and dental professionals and drives global health innovation in collaboration with partners across sectors.

What you’ll do

The Administrative Assistant will provide operational and regulatory support to the gastroenterology research team, including managing study documentation and coordinating monitoring visits. They are responsible for ensuring all regulatory binders are audit-ready and assisting with study start-up and closeout activities.

Requirements

Candidates must have a high school diploma and at least two years of experience working in an academic clinical research setting. Proficiency in Microsoft Office and trial portals, along with strong organizational and communication skills, is required.

Benefits

• Comprehensive benefits package

Listed skills

• Problem solving · Preferred
• Attention to detail · Preferred
• Communication · Preferred
• Microsoft Office · Preferred
• scheduling · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory documentation
• Clinical trials
• Gastroenterology research
• Study maintenance
• Scheduling
• Audit preparation
• Microsoft Office
• Trial portals
• Communication
• Problem solving
• Organizational skills
• Attention to detail
• Data reconciliation
• Workflow coordination
• Maintenance Scheduling
• Regulatory Documents
• Influencing Skills
• Administrative Support
• Professionalism
• Workflow Management
• Organizational Skills
• Results Orientation
• Administrative Functions
• Microsoft Teams
• Research
• Adaptability
• Auditing
• Dentistry
• Reconciliation
• Management
• Cardiopulmonary Resuscitation (CPR)
• Clinical Trials
• Gastroenterology
• Health Sciences
• Psychology
• Innovation
• Problem Solving
• Knowledge-Based Systems
• Operations
• Safety Training
• Environment Health And Safety
• Coordinating
• Collections
• Diversification (Investing)
• Teamwork
• Detail Oriented

Job areas

• Administrative
• Science & Research
• Healthcare
• Clinical Administrative Assistant
• Medical Assistant
• Medical Assistants

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