09 Jan
University of Calgary
Calgary
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.
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, demonstrating 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 on 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 16, 2025
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.
#J-18808-Ljbffr
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.