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Clinical Research Coordinator I
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**About Care Access** Care Access is working to make the future of health better for all. **With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care.**We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, **and contribute to the medical breakthroughs of tomorrow.** With programs like _Future of Medicine_, which makes advanced health screenings and research opportunities accessible to communities worldwide, and _Difference Makers_, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. **How This Role Makes a Difference**: **How You'll Make An Impact**: - 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. **The Expertise Required**: - Excellent working knowledge of medical and research terminology - Excellent working knowledge of federal regulations, good clinical practices (GCP) - Ability to communicate and work effectively with a diverse team of professionals. - Strong organizational, prioritization and leadership skills and capabilities with a strong attention to detail - Strong computer skills with demonstrated abilities using clinical trials database, IVR systems, electronic data capture, MS word and excel. - Critical thinker and problem solver - Friendly, outgoing personality; maintain a positive attitude under pressure. - High level of self-motivation and energy - Excellent professional writing and communication skills - Ability to work independently in a fast-paced environment with mínimal supervision. - **Certifications/Licenses, Education, and Experience**: - Bachelor's Degree preferred, or equivalent combination of education, training and experience. - A minimum of 1 year prior Clinical Research Coordinator experience required - Recent phlebotomy experience required **How We Work Together**: - **Location**: 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 (
