Clinical Trials Coordinator, Paediatrics

3 weeks ago

Calgary, Canada The University of Calgary Full time

**Description**

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

Work at multiple sites may be required (primary location is at the Alberta Children's Hospital). This position will work in a fast-paced environment with potentially conflicting deadlines, in which an astute ability to prioritize is required.

Reporting to the Principal Investigator.

**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**: January 2, 2025

This position is part of the AUPE bargaining unit, and falls under the **_Specialist/Advisor Job Family, Phase 2_**.

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 Strate

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