Clinical Trials Coordinator, Paediatrics

Description

The Department of Paediatrics in the Cumming School of Medicine invites applications for a Clinical Trials Coordinator. This Full-time Fixed Term position is for approximately 6 months (based on length of grant funding), with the possibility of extension.

Reporting to the Principal Investigator.

This position plays a key role in overseeing the development, coordination, implementation, and management of single and multi-center phase I-IV clinical trials as part of a new initiative at the Alberta Children's Hospital through the development of a Clinical Trials Unit.

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

Clinical Trials Management

• Support the design, planning, and development of clinical trial protocols (eligibility criteria, recruitment strategies and endpoints) for specific pediatric populations, including populations often under-represented in clinical trials

• Obtain necessary approvals from ethics committees, regulatory authorities, and other relevant bodies for trial initiation

• Monitor and manage trial progress and resolve any challenges that arise during the trial

• Oversee the planning, initiation, and execution of multiple clinical trials, ensuring that each trial adheres to predefined timelines, budgets, and objectives

• Coordinate and communicate with cross-functional teams, including healthcare professionals, clinical research staff, data managers, finance, legal and ethics staff to ensure seamless trial operations

• Contribute to the development of clinical trial strategies, including patient recruitment and retention plans that promote equity, diversity and inclusion

Regulatory Compliance

• Ensure compliance with all relevant provincial and federal regulations, guidelines, and ethical standards related to clinical trials in Alberta

• Collaborate with local regulatory affairs team (Calgary Centre for Clinical Research) to prepare and submit trial-related documents to ethics committees, Health Canada, and other regulatory bodies

• Stay updated on the latest developments in clinical trial regulations, guidelines, and technologies, and incorporate them into the institute's processes

Coordination and Collaboration

• Facilitate effective communication and collaboration among multidisciplinary teams involved in clinical trials

• Ensure high degree of confidentiality and integrity, demonstrate discretion, professionalism and good judgement in dealing with confidential information

Data Management, Reporting, and Quality Assurance

• Oversee data collection, management, and quality control processes to ensure accuracy, integrity, and confidentiality of trial data

• Prepare regular reports and trial progress, results, and outcomes for researchers and stakeholders

• Collaborate with researchers and analysts to analyze trial results

Qualifications / Requirements:

• MSc (or higher), or equivalent experience, in a health-related discipline (e.g., life sciences, medicine) required
• A minimum of 3 years of experience in clinical research and trial management, preferably in a medical or research institute setting is preferred, but shorter duration may be considered in conjunction with other relevant experience
• Solid knowledge of clinical trial regulations, Good Clinical Practice (GCP), and ethical standards (TCPS training required and other clinical trial certifications considered an asset)
• Proven track record in successful clinical trial coordination and management, including participant enrolment, innovative trial design, and trial surveillance
• Strong project management and organizational skills, with the ability to handle multiple trials simultaneously
• Excellent communication and interpersonal skills required to effectively collaborate with diverse teams and stakeholders
• Proficiency in clinical trial software and databases
• Excellent research and technical writing skills required
• Proficiency in data management
• Strong problem-solving skills, adaptability, and attention to detail
• Experience working with Alberta Health Services is considered an asset

Application Deadline: April 26, 2024

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 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.

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 Equity, Diversity and Inclusion (equity@ucalgary.ca) and requests for accommodations can be sent to Human Resources (hrhire@ucalgary.ca).

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.