Clinical Research Coordinator

3 days ago

Thunder Bay, Canada Care Access Full time

**What We Do** Care Access is a unique, multi-specialty network of research sites that operates as one connected team of physician investigators, nurse coordinators, and operations managers. **Who We Are** We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another, find new ideas to accelerate medicine, and seed a long-term impact for generations. **Position Overview** **What You'll Be Working On** **Duties include but not limited to**: - Ability to understand and follow institutional SOPs. - Review and assess protocol (including amendments) for clarity, logístical feasibility - Ensure that all training and study requirements are met prior to trial conduct - Discuss study medication, required procedures, eligibility criteria and impact on office flow with Investigator and site staff - Assist with planning and creation of appropriate recruitment materials - Attend Investigator meetings as required. - Coordinate and attend pre-study site visits, site initiation visits, and monitor visits with clinical staff and Sponsor/CRO representatives - Assist in the creation and review of source documents. - Ensure adequate supplies have arrived on site for protocol initiation (lab kits, study medication, specialized equipment, IVRS/EDC access and passwords) **Study Management**: - Prioritize activities with specific regard to protocol timelines - Maintain adherence to Health Canada Division 5 regulations and ICH guidelines in all aspects of conducting clinical trials. - Maintain effective relationships with study participants and other Care Access personnel. - Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access personnel and management. - Communicate clearly verbally and in writing. **Patient Coordination**: - Obtain informed consent per Care Access SOP. - Complete visit procedures in accordance with protocol. - Train others and complete basic clinical procedures, such as blood draws, vital signs, ECGs, etc. - Review laboratory results, ECGs, and other test results (e.g., MRIs) for completeness and alert values, ensuring investigator review in a timely fashion. - Identify adverse events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator and Sponsor (where appropriate) **Documentation**: - Record data legibly and enter in real time on paper or e-source documents - Accurately record study medication inventory, medication dispensation, and patient compliance. - Resolve data management queries and correct source data within sponsor provided timelines - Assist regulatory personnel with completion and filing of regulatory documents. - Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. **Physical and Travel Requirements**: - This is an on-site position with regional commute requirements. Regularly planned travel within the region will be required as part of the role. Overnight travel will be mínimal (

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