QUALIFICATIONS:

• Minimum 5 years of clinical research experience in a hospital 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.)
• Advanced 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 to take lead on assigned projects and as part of a team

• Function as part of a interdisciplinary, patient-focused team of professionals to ensure smooth and efficient facilitation of clinical trial activities
• Lead the day-to-day activities of a clinical trial including pre-screening/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
• Support the development and execution of high level strategic initiatives within the Nephrology research program