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Clinical Research Coordinator I
Care AccessFayetteville, United Statesfull_timeVerifiedPosted 7 Oct 2024
About the role
Clinical Research Coordinator I What We DoCare 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 AreWe 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 OverviewThe Clinical Research Coordinator’s primary responsibilities are to utilize Good Clinical Practices (GCP)s in the process of screening, enrolling and closely monitoring clinical research study subjects while ensuring protocol and regulatory compliance. What You'll Be Working OnDuties include but not limited to:● Ability to understand and follow institutional SOPs.● Review and assess protocol (including amendments) for clarity, logistical 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.● Assist in development of recruitment plan and obtain listing of potential candidates to contact from subject database.● Actively work with recruitment team in calling and recruiting subjects ● 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 FDA 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:● Prescreen study candidates ● 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·
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