Specialist, Study Training Compliance & DOA Management

📋 Description

• • **About Care Access:**
• • Care Access is at the forefront of revolutionizing healthcare by making the future of health better and more accessible for everyone. With a vast network of hundreds of research locations, mobile clinics, and dedicated clinicians worldwide, we are committed to bringing world-class research and essential health services directly to the communities that need them most, particularly those facing barriers to care. Our mission is to empower every individual with the knowledge of their health, provide access to necessary medical services, and enable them to contribute to the groundbreaking medical advancements of tomorrow. Through innovative programs like 'Future of Medicine,' which democratizes access to advanced health screenings and research opportunities globally, and 'Difference Makers,' which champions local leaders in expanding community health and wellbeing initiatives, we place people at the very heart of medical progress. By fostering strategic partnerships, leveraging cutting-edge technology, and demonstrating unwavering perseverance, we are fundamentally reimagining how clinical research and healthcare services reach the global population. Together, we are building a future of health that is not only more effective but also more equitable and accessible for all.
• • **How This Role Makes a Difference:**
• • Care Access is actively seeking a highly skilled and experienced Specialist, Study Training Compliance and DOA Matrix Management to become an integral part of our dynamic Central Support Operations team, which falls under the Global Expansion and Study Operations department. In this pivotal role, you will be instrumental in supporting critical compliance functions, ensuring that study training requirements and delegation matrices are meticulously managed across all our clinical research studies. Your contributions will directly impact site staff readiness and ensure robust regulatory adherence by diligently tracking training completion, maintaining essential clinical staff records, and verifying that Delegation of Authority (DOA) matrices are complete, thoroughly reviewed, and appropriately approved in strict accordance with our established standard operating procedures. The ideal candidate will possess exceptional organizational skills, a responsive and proactive approach, and a genuine passion for upholding the highest standards of quality within a regulated, fast-paced, and evolving environment.
• • **How You'll Make an Impact:**
• • **Study Training Compliance:**
• • Diligently track and monitor the completion of all required training for clinical staff, encompassing both study-specific training modules and essential mandatory compliance training programs.
• • Provide crucial support during the study start-up phase by meticulously verifying that staff training records align precisely with their assigned roles and responsibilities within the study.
• • Ensure that all training documentation is comprehensive, up-to-date, and fully compliant with ICH-GCP guidelines, internal Standard Operating Procedures (SOPs), and specific sponsor requirements.
• • **Delegation of Authority (DOA) Coordination:**
• • Actively support the setup and ongoing maintenance of DOA matrices by confirming the completion of necessary training and the accuracy of role assignments for all personnel involved.
• • Collaborate effectively with various internal departments and cross-functional teams to ensure that delegation processes are streamlined and that sites are fully prepared for protocol activities and seamless study transitions.
• • **eISF & Documentation Management:**
• • Upload, organize, and maintain all essential staff training records, certifications, and relevant personnel documents within the electronic Investigator Site File (eISF) and any other associated systems.
• • Ensure that all site staff training records are consistently maintained in an audit-ready state, fully aligned with both regulatory expectations and sponsor requirements.
• • Provide essential support during internal audits, site monitoring visits, and in response to sponsor document requests, ensuring timely and accurate provision of information.
• • **General Support & Collaboration:**
• • Foster strong collaboration with internal stakeholders to effectively support study training initiatives and streamline access coordination throughout all phases of a study.
• • Actively participate in team meetings, contributing to the development and refinement of documentation and communication tools to enhance overall team efficiency and effectiveness.
• • Proactively escalate any identified issues or potential delays to senior team members to ensure that critical study and site compliance timelines are consistently met.
• • Maintain clear, concise, and professional communication with internal staff, sponsors, and external vendors regarding compliance tasks, progress, and timelines.
• • Contribute to problem-solving efforts related to training or access issues, working collaboratively with the broader team to develop and implement effective solutions.
• • Perform other duties as assigned, recognizing that the responsibilities listed are representative and may not be exhaustive.