Senior Clinical Trial Program Administrator, Clinical Research

University of Calgary; Calgary; On-site; CAD 90,000 - 115,000; Full time

Job summary

The University of Calgary’s Department of the Clinical Research is seeking a Senior Clinical Trial Program Administrator for a full-time fixed-term role of about one year. You will monitor trials, develop training programs, and coordinate regulatory submissions to ensure high-quality conduct and compliance.

You will work under the Lead Regulatory Officer in the Clinical Research Team, contributing to monitoring plans, audits, and education initiatives across investigator-initiated trials

Qualifications

• Bachelor’s degree in health science or equivalent; Master’s preferred.
• 5+ years of clinical trial coordinating experience in regulated trials.
• GCP, Health Canada Division 5 and TCPS-2 certificates required.
• ACRP or SoCRA certification is an asset.
• Strong regulatory, ethics and contractual knowledge for trials.

Responsibilities

• Lead study monitoring visits and develop monitoring plans.
• Support training programs for researchers and teams.
• Assist internal audits and preparations for regulator inspections.
• Provide regulatory navigation and review of submissions.
• Maintain clinical research webpages and service roadmaps.

Skills

Regulatory knowledge

Attention to detail

Time management

Problem solving

Communication skills

Team collaboration

Education

Bachelor's degree in health science or equivalent

Master's degree preferred

Tools

GCP certification

Health Canada Division 5

TCPS-2 certification

ACRP or SoCRA certification

Clinical trial monitoring knowledge

Job description

Description

The Department of the Clinical Research in the Cumming School of Medicine invites applications for an Senior Clinical Trial Program Administrator. This Full-time Fixed Term position is for approximately 1 year (based on length of grant funding), with the possibility of extension.

The Senior Clinical Trial Program Administrator reports to the Lead Regulatory Officer, Clinical Research, Cumming School of Medicine and supports the CCCR Quality Assurance and Regulatory Compliance Team at the University of Calgary. Under the guidance of the Lead Regulatory Officer - Clinical Research, the incumbent works within the team to set-up and run clinical trial services such as monitoring services and education training services and initiatives that require in-depth knowledge about the regulatory requirements and conduct of clinical trials. The Senior Clinical Trial Program Administrator is responsible for ensuring that Investigator Initiated Trials sponsored by the University of Calgary meet regulatory requirements and are conducted to a high-quality standard. Key components of the program include: clinical trial monitoring for quality control purposes; development and delivery of training and education programs for researchers and their teams; developing and implementing clinical research monitoring policies and standards; establishing standard operating procedures; ensuring monitoring protocols are followed and maintained; and preparing researchers for industry sponsored, government and internal monitoring visits and audits.

The Senior Clinical Trial Program Administrator serves as a critical control to mitigate serious risk to human participants enrolled in these studies as well as to the University of Calgary. The emphasis of this position is to support compliance in the conduct of clinical trials sponsored by the University to ensure human participant¿s rights or safety are protected, data collected and reported are accurate, and that all trials and their sub sites comply with local, national and international standards, policies and regulations for clinical research involving human participants.

Summary of Key Responsibilities (job functions include but are not limited to):

Clinical Trial Monitoring:

• Takes leadership role as study monitor to schedule and conduct monitoring visits
• Creates monitoring plans & site initiation consultations
• Performs institutional-level study risk-assessments to ensure site monitoring is risk-based
• Performs site close-out visits
• Prepares summary statistics and reports for leadership, as required

Supports enhancement of the CSM clinical research training program:

• Seeks out and completes continuous training on relevant regulations
• Develops and maintains a roadmap of University of Calgary clinical research support services
• Development and delivery of clinical research training (1:1 training and group training)

Supports Internal Audits and External Regulatory Agency Inspections:

• Contributes to internal audits, performing and reporting on file reviews and following up with research teams as assigned by the Lead Regulatory Officer ¿ Clinical Research
• Assists research teams with preparing for agency inspections as assigned by the Lead Regulatory Officer ¿ Clinical Research

Provides regulatory and navigation support to research teams:

• Responds to regulatory questions raised by research teams
• Assists research teams with accessing and navigating clinical research support services through events and day to day support
• Assists with the consultation and review of regulatory submissions
• Assists with the development and maintenance of the webpages for the Calgary Centre for Clinical Research

Qualifications / Requirements:

• Bachelor's degree in a health science related field or equivalent. Master¿s degree preferred
• 5+ years of clinical trial coordinating experience in regulated clinical trials demonstrating deep knowledge and understanding of clinical trial work processes
• Training certificates in Good Clinical Practice (GCP), Health Canada Division 5, TCPS-2 is required
• Understanding of the Cannabis Act and Controlled Substances regulations is an asset
• Maintains a current Clinical Research Certification (ACRP or SoCRA) is an asset
• Demonstrated knowledge and understanding of clinical trial monitoring. Formal training or certification in clinical trial monitoring would be an asset
• Demonstrated knowledge and understanding of the regulatory, ethics and contractual requirements for the conduct of clinical trials
• Strong organizational and time management skills
• Highly developed attention to detail
• Demonstrated ability to solve complex problems
• Proven ability to work as a member of a team, as well as independently
• Excellent communication skills, both written and verbal
• Excellent computer skills in a Windows environment using the Microsoft Office Suite
• Experience using a clinical trial management system would be an asset
• Knowledge of University culture and cross-departmental policies would be an asset

Application Deadline: October 7, 2026

We would like to thank all applicants in advance for submitting their resumes. Please note, only those candidates chosen to continue on through the selection process will be contacted.

This position is part of the AUPE bargaining unit, and falls under the Specialist/Advisor Job Family, Phase 3.

For a listing of all management and staff opportunities at the University of Calgary, view our Management and Staff Careers website.

About the University of Calgary

UCalgary is Canada's entrepreneurial university, located in Canada's most enterprising city. It is a top research university and one of the highest-ranked universities of its age. Founded in 1966, its 36,000 students experience an innovative learning environment, made rich by research, hands‑on experiences and entrepreneurial thinking. It is Canada's leader in the creation of start‑ups. Start something today at the University of Calgary. For more information, visit ucalgary.ca.

The University of Calgary has launched an institution-wide Indigenous Strategy ii' taa'poh'to'p committing to creating a rich, vibrant, and culturally competent campus that welcomes and supports Indigenous Peoples, encourages Indigenous community partnerships, is inclusive of Indigenous perspectives in all that we do.

The university's commitment to the Indigenous Strategy is evident through the oversight of 18 Elders serving on the Circle of Advisors and the many unit-based circles working towards implementation of the strategy including the Faculty Advisory Circle and teams such as the Office of Indigenous Engagement, the Writing Symbols Lodge, and the Indigenous Research Support Team. Many Indigenous-based events and processes are impacting curriculum, programming and polices at the University of Calgary.

As an equitable and inclusive employer, the University of Calgary recognizes that a diverse staff/faculty benefits and enriches the work, learning and research experiences of the entire campus and greater community. We are committed to removing barriers that have been historically encountered by some people in our society. We strive to recruit individuals who will further enhance our diversity and will support their academic and professional success while they are here. In particular, we encourage members of the designated groups (women, Indigenous peoples, persons with disabilities, members of visible/racialized minorities, and diverse sexual orientation and gender identities) to apply. To ensure a fair and equitable assessment, we offer accommodation at any stage during the recruitment process to applicants with disabilities. Questions regarding [diversity] EDI at UCalgary can be sent to the Office of Institutional Commitments ([e-mail]) and requests for accommodations can be sent to People & Culture ([e-mail]).

Do you have most but not all the qualifications? Research show that women, racialized and visible minorities, and persons with disabilities are less likely to apply for jobs unless they meet every single qualification. At UCalgary we are committed to achieving equitable, diverse, inclusive and accessible employment practices and workplaces and encourage you to apply if you believe you are right for this role.

We encourage all qualified applicants to apply, however preference will be given to Canadian citizens and permanent residents of Canada.