Clinical Systems Coordinator

Job Summary of the Clinical Systems Coordinator

The Clinical Systems Coordinator is responsible for administering Axogen’s clinical systems, including Veeva Vault, performing quality control of clinical trial documents, and supporting study start-up and coordination activities. This role ensures compliance with regulatory standards, supports in-house and remote monitoring initiatives, and facilitates efficient clinical operations through system and process management. Additionally, the Clinical Systems Coordinator contributes to the development, growth, and maintenance of Clinical Research Systems and Infrastructure to ensure scalability and operational excellence. This role requires close collaboration with internal and external stakeholders to streamline processes, enhances system capabilities, and support Axogen’s clinical trial objectives.

Requirements of the Clinical Systems Coordinator

• Bachelor’s degree in a medical, scientific, engineering, or computer systems discipline or a commensurate combination of training and experience;
• Prior experience with industry-sponsored clinical research is strongly preferred.
• 1-2 years of prior experience working with Veeva Clinical Suite is preferred.
• A strong working knowledge of Good Clinical Practices governing human subject testing is strongly preferred.
• Strong critical thinking and discretionary decision-making skills;
• Strong organizational and time-management skills;
• Ability to multi-task and prioritize autonomously in a fast-paced environment;
• Excellent written & oral communication skills;
• Ability and willingness to travel (up to 10% of the time).

Responsibilities of the Clinical Systems Coordinator

The specific duties of the Clinical Systems Coordinator include but are not limited to:

• Configuring, managing, and maintaining Axogen’s Veeva Vault (eTMF, CTMS, Payments, etc.) to meet organizational and regulatory standards.
• Administering user roles, permissions, and access controls for Veeva Vault and related clinical systems to ensure system security and data integrity.
• Collaborating with IT, vendors, and external partners to address technical issues, system upgrades, validation activities, and system enhancements in compliance with Axogen’s Quality Management System.
• Managing metadata for document uploads and coordinating necessary changes with internal teams.
• Monitoring system performance, facilitating integration between clinical systems, and providing troubleshooting and resolution support.
• Assist in initiatives to validate and implement new clinical systems or upgrades, ensuring alignment with GxP standards and organizational objectives.
• Creating and maintaining system configuration guides, workflows, and user manuals to support internal teams and stakeholders.
• Ensuring backups, disaster recovery processes, business continuity plans, and audit trails are in place to maintain compliance and data security.
• Establishing and maintaining system metrics dashboards to monitor user activity, system health, and performance while preparing reports for leadership.
• Conducting Quality Control (QC) reviews of essential study documents and Trial Master Files to ensure compliance with GCP, ICH guidelines, and regulatory requirements.
• Assessing and reviewing documents with stakeholders to ensure they are inspection-ready and addressing identified gaps proactively.
• Tracking and reporting TMF health metrics (completeness, timeliness, and quality) to ensure continuous improvement and audit readiness.
• Completing annual eTMF reviews with the Clinical Operations team to ensure compliance with Axogen’s documentation standards.
• Developing and maintaining SOPs, work instructions, and detailed training materials, including user manuals, quick reference guides, and video tutorials.
• Delivering training programs for staff on clinical systems (e.g., CTMS, eTMF) and designing role-specific modules tailored to individual needs or onboarding requirements.
• Conducting periodic refresher training sessions to reinforce knowledge of regulatory requirements, system updates, and process improvements.
• Continuously enhancing training programs based on user feedback, system changes, and evolving regulatory requirements.
• Supporting change management initiatives by educating staff on new systems, upgrades, or process changes for seamless adoption and integration.
• Acting as a liaison between Clinical Systems and other departments to ensure efficient communication and resolution of system-related challenges.
• Facilitating cross-functional collaboration to align system strategies with organizational goals, prioritizing scalability, compliance, and operational excellence.
• Other projects and duties as required/assigned.

Location

111 West Oak Ave., Tampa, FL  33602

Benefits/Compensation