Job Description

Summary Of Duties
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
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

Job Tags

Full time, Work at office,

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