Clinical Research Coordinator II

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 The 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.   How You'll Make An Impact Coordination and Conduct of Clinical Trials Study Planning and Scheduling: Prioritizing tasks according to study protocol timelines. Managing scheduling conflicts between visits and procedures through close collaboration with Investigators, nurses, and the PSC. Regulatory Compliance: Adhering to FDA and ICH GCP guidelines in clinical trial conduct. Ensuring all study procedures are performed in accordance with Good Clinical Practice (GCP) standards. Maintaining knowledge of and compliance with internal Care Access SOPs in daily activities. Collaboration with the Study Team and Participants: Professional communication with the Principal Investigator (PI), study staff, and Sponsor/CRO representatives. Close cooperation with investigators and the study team, supporting investigators and nurses during patient visits, and ensuring patient documentation is prepared prior to visits. Maintaining participant relationships in alignment with protocol and ethical requirements. Training participants on study materials (e.g., paper or electronic diaries), supporting device usage, verifying entries, issuing and collecting diaries, etc. Monitoring Quality and Safety: Tracking quality metrics and visit outcomes. Supporting investigators in identifying and reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) in line with protocol and procedures. Preventing protocol deviations and promptly resolving issues in documentation and study processes. Participating in selection, initiation, monitoring, and close-out visits; collaborating with monitors, analyzing findings from post-visit letters, implementing corrective actions, and confirming completion of all prior visit issues. Preparing the site for audits and inspections and participating in these activities. Controlling versions of key study documents (Investigator’s Brochure, protocol, manuals). Verifying investigators’ review and documentation of safety reports (SUSARs). Ensuring correct execution of informed consent forms (ICF) and proper documentation of the consent process. Clinical Trial Documentation Data Registration and Verification: Accurate and timely verification of data in both paper and electronic documentation (e-source, if applicable) and entering data into study systems (eCRF, IVRS, etc.). Ensuring completeness of data and adherence to protocol requirements. Managing the Investigator Site File (ISF), ensuring completeness, and obtaining necessary documents from team members. Preparing documentation for participant requests and, if electronic, delivering the package via PSC. IMP Control and Compliance Monitoring: Monitoring participant compliance, tracking returned medications, and notifying investigators of discrepancies. Responding to alerts from study systems (lab, IVRS, e-diaries) and confirming investigator acknowledgment. Supporting nursing staff in reporting issues to the CRO and responding to queries. Query Resolution and Regulatory Support: Resolving data queries within the designated timeframe. Collaborating with the regulatory team to prepare and archive study documents. Assisting with source documentation and CRF review, including transmitting requests for source creation, providing study documents, implementing and verifying corrections, and consolidating team feedback. Updating key study documents on the site OneDrive (protocol, ICF, CVs, GCP certificates). Study Start-Up Support Submission Documentation Preparation: Compiling and preparing all documents required by Sponsor/CRO.   Ensuring all documents are correctly completed and compliant with guidelines.   Verifying signatures and dates before submission.   Staff Documentation and CV Management: Preparing investigator and study staff CVs using Sponsor/CRO templates (if applicable).   Updating and verifying personal data and qualifications of the study team.   Coordination with Study Team and Sponsor/CRO: Providing complete, accurate, and signed documentation to Sponsor/CRO.   Collaborating with PI, study staff, and regulatory teams to ensure documentation compliance.   Supporting preparation of all materials required for study start-up approval.   Document Quality Control: Verifying completeness and compliance of documents with protocol and regulatory requirements.   Ensuring documentation readiness for formal submission and archiving.   Site Training and Preparation Study-Specific Training: Conducting timely trainings and clinical trial sessions, participating in Sponsor/CRO training