Full Job Description
Responsibilities will include but are not limited to:
• Function as part of a interdisciplinary, patient-focused team of professionals to ensure smooth and efficient facilitation of clinical trial activities
• Manage day-to-day activities of a clinical trial including screening and recruiting eligible participants, obtaining informed consent, collecting and managing study data and ensuring compliance with protocols and regulatory guidelines
• Initiate, manage, and coordinate submissions to Research Ethics Board and contracts for Legal Review
• Communicate with internal hospital departments to complete impact assessments, facilitate departmental research agreements and obtain institutional approvals
• Financial duties relating to clinical trial activities including budget development, invoicing and study-related patient reimbursements
• Establish, maintain and complete all essential documents in Investigator Site File (ISF) ensuring adherence to regulatory requirements
• Coordinate patient follow-up visit schedules as per study protocol and execution of all aspects of study visits including protocol specific assessments such as obtaining patient vitals, electrocardiograms and sample collection/processing
• Report Adverse Events/Serious Adverse Events as per protocol and sponsor requirements
• Liaise with sponsors as required
• Prepare for monitoring visits, audits and inspections
• Provide support to Site Operations Manager in tasks including but not limited to collection/reporting of institutional Key Performance Indicators, establishing clinical trial workflows and tools/templates
• Support implementation of a clinical trial management system
Qualifications:
• Minimum 3 years of clinical research experience in a hospital setting or clinical research setting
• Bachelor's degree in health-related field required, Master's degree is an asset
• Recognized certification in clinical research (ACRP or SOCRA) is an asset
• Training and experience or willingness to be trained in Phlebotomy/Venipuncture practice required
• Demonstrated knowledge of research regulations and guidelines (ICH/GCP, Health Canada, Tri-Council Policy, Declaration of Helsinki, etc.)
• Proficiency in computer skills (Microsoft Office: Word, Excel, PowerPoint, Adobe)
• Experience with Clinical Trial Management Systems and Electronic Data Capture systems an asset
• Strong oral and written communication skills
• A "can do" attitude: Flexibility to work in a complex environment with ability to multitask and prioritize to meet deadlines
• Demonstrates initiative and the ability to work effectively both independently and as part of a team
WELL Health Diagnostic Centres does not use artificial intelligence-assisted tools as part of the recruitment process.
This role is for an existing vacancy. The expected hiring range for this role is from $100,000 to $120,000 annually. Final compensation is determined based on market location, job-related knowledge, skills, experience level, and internal equity. Candidates with significantly more experience may be considered at a higher level with adjusted compensation for certain roles.
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