Central Study Coordinator I

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 to 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. To learn more about Care Access, visit  www.CareAccess.com . How This Role Makes a Difference Central Clinical Services enables decentralized and hybrid clinical trials by providing staff who virtually support patients and sites. The Central Study Coordinator (CSC) position combines clinical research and project management skills into a singular role that delivers a strong customer experience for both patients and site s.  Often  representing  Care Access and/or a Care Access client,  t he CSC acts as a virtual extension of the research site and supports one to four sites concurrently across one or more studies. The CSC is  accountable for study delivery at the patient level, including screening, consenting, and conducting protocol mandated study visits, and is expected to coordinate daily work using patient centric practices and a quality-first approach. The CSC also serves as a project manager for their assigned studies with their assigned PIs, helping their  sites to  stay on top of study deliverables in line with sponsor and CRO expectations. As such, this role will also manage monitoring visits, data management, and query resolution for their assigned sites, and ensure ongoing  inspection  readiness. This is a mid-to-senior level individual contributor role with the expectation that the CSC has strong working knowledge of and experience in the clinical research industry.   How You'll Make An Impact Study/Patient Coordination   Perform the Informed Consent process with study participants virtually using e-consent technology. Review all elements of the ICF with the participant and assess their understanding to ensure the protection of human participants in clinical research. Complete signatures using the e-consent platform and register participants in IWRS .  Pre-screen and educate potential study participants on the study.   Analyze, understand, and be knowledgeable of the study protocol and the associated disease(s) in combination to be able to educate patients and their families on what  participating  in the study means for the patient   Interpret patient reported medical history and medication use to  determine  pre-screening qualification for a study   Manage participant referral portals and study specific applications in real time in accordance with GCP.   Schedule, prepare for, and facilitate participant visits in accordance with the study protocol. This may include overseeing the required scheduling, logistics, technology requirements, and communication applications for participants, central raters, investigators, and other study-related entities such as MRI centers and infusion centers .    Perform protocol mandated visit activities while maintaining GCP compliance   Documentation Management   Maintain all study documentation in accordance with ALCOA-C and across multiple study portals.     Collect sensitive data that is used to determine overall study effectiveness   Create and manage sensitive source documentation for multiple studies including maintaining document security, quality assurance, and secure transmission to clients in a remote environment   Enter data and resolve queries in EDC and other portals within appropriate time window defined by the study   Correctly identify, document, and report Adverse Events and Serious Adverse Events (AEs and SAEs)     Ensure all study trackers and systems are up to date daily   Support site compliance with subject safety reporting   Study Project Management   Manage study work for each assigned site as delegated by the PI, collaborating with multiple sites and site teams concurrently to deliver the highest quality work with each participant for each site.   Requires juggling multiple unique protocols of varying complexity   Host regular calls, acting as the subject matter expert and representative of Care Access, w ith each assigned PI and present on key elements of the study within CSC scope, which may include a review of new referrals, participants in screening, participants in treatment, data and query progress and issues, upcoming monitoring visits, etc.   Prepare meeting agendas and circulate meeting minutes, follow-up on action items for self and teammates.   Facilitate communication between study site, CRA, and sponsor.    Other Responsibilities Build strong rapport with sites, participants, CRAs, and sponsor contacts.    Make decisions that  optimize  the experience within the study for the  participant , PI, and other site staff.    Perform quality checks for self and others to ensure overall data integrity .    Complete ongoing  trainings  and adhere to system access guidelines .  Analyze and understand study protocols.      The Expertise Required Knowledge, Skills, and Abilities Able to navigate and troubleshoot a wide variety of technologies used for clinical research including recruitment platforms, IWRS, EDC, and other clinical trial software, a