Senior Clinical Research Coordinator

Summary : The Clinical Research Coordinator III (CRC III) is a senior-level position responsible for leading and managing clinical research projects with a high degree of autonomy. In addition to mastering the competencies of the CRC II role, the CRC III demonstrates advanced skills and knowledge, guiding and training study team members in the implementation of study-related activities. The CRC III applies critical thinking and creative problem-solving skills across a wide variety of clinical studies. They contribute to the development of new processes, procedures, tools, and training to enhance clinical research activities across competency domains. Additionally, the CRC III performs quality assurance / quality control (QA / QC) checks of the work of others and continuously invests in ongoing continuing education and professional development.

Duties and Responsibilities : The Senior Clinical Research Coordinator :

• Leads study teams in executing clinical trials, ensuring compliance with study protocols, regulatory requirements, and institutional policies.
• Mentors and trains RA I, RA II, CRC I, and CRC II team members, providing ongoing guidance and education.
• Designs and implements quality improvement initiatives to enhance study efficiency and compliance.
• Serves as the primary point of contact for sponsors, investigators, and key stakeholders.
• Evaluates study performance metrics and implements strategies to achieve enrollment and quality goals.
• Guides teams in troubleshooting and resolving study-related challenges, ensuring study timelines are met.
• Develops and refines study procedures and best practices for research teams.
• Oversees and leads project start-up activities, including protocol training, source document development, and regulatory compliance.
• Conducts pre-randomization (pre-rando) reviews and finalizes source documentation.
• Resolves complex study issues with sponsors, CROs, and regulatory bodies.
• Ensures protocol amendments are implemented effectively, training staff as needed.
• Monitors end-of-visit meetings to ensure compliance and completeness of study assessments.
• Coordinates and oversees investigational product (IP) management, ensuring proper documentation and accountability.
• Conducts QA / QC reviews of study records, source documents, and lab orders.
• Delegates DOA (Delegation of Authority) duties, ensuring appropriate team assignments.
• Performs quality assurance checks on team members' work to ensure adherence to regulatory requirements.
• Develops and oversees Lessons Learned initiatives to improve study execution.
• Reviews and finalizes Notes to File (NTFs) to ensure compliance with regulatory guidelines.
• Assists in vendor setup for test scans and manages site interactions with external vendors.
• Leads site preparation for audits and inspections, ensuring all documentation is up to date and compliant.
• Strategizes to optimize subject enrollment and retention, adjusting workflows as necessary.
• Works with recruitment teams to generate subject leads and meet enrollment targets.
• Notifies management when SF (Screen Fail) ratios need adjustment for protocol optimization.
• Develops and implements study-specific training sessions for staff.
• Manages project performance to increase profitability and operational efficiency.
• Serves as the primary liaison between the site, sponsors, CROs, and regulatory authorities.
• Ensures effective communication and collaboration between research teams, investigators, and sponsors.
• Leads sponsor monitoring visits and ensures all action items are addressed in a timely manner.
• Assists in the preparation of study reports, audits, and presentations for leadership teams.
• Occasional travel to Company sites, Investigator meetings, and / or Company meetings as required.
• Performs other miscellaneous job-related duties as assigned by their manager.

Requirements :

Competency Requirements :

Physical Requirements and / or environmental factors :