Clinical Research Coordinator
2 weeks ago
**What We Do** Care Access is delivering the future of medicine today Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck, Care Access is helping accelerate the approval and delivery of critical and life-saving therapies. **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 are 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 Research personnel. - Interact in a positive, professional manner with patients, sponsor representatives, investigators and Care Access Research personnel and management. - Communicate clearly verbally and in writing. **Patient Coordination**: - Obtain informed consent per Care Access Research 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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