Clinical Research Coordinator III

Description

The Clinical Research Coordinator III (CRC
3) is a senior-level clinical research professional responsible for independently coordinating and managing complex clinical research studies while ensuring compliance with regulatory, protocol, and institutional requirements. In addition to overseeing study conduct and participant management, the CRC 3 serves as a team leader and subject matter expert who contributes to process improvement initiatives and supports the development of high-quality clinical research operations across the department.

• Independently coordinate and manage clinical research studies from participant screening and enrollment through study completion.
• Assess potential research participants for protocol eligibility in collaboration with Principal Investigators and study teams.
• Obtain and document informed consent and ensure ongoing compliance with protocol requirements and institutional policies.
• Coordinate and conduct study visits, including specimen collection, processing, storage, shipment, and documentation.
• Collect, enter, maintain, and validate clinical research data within study databases and data collection systems.
• Collaborate with regulatory personnel to ensure all required regulatory documents are current, complete, and maintained appropriately.
• Maintain compliance with Good Clinical Practice (GCP), HIPAA, sponsor requirements, and applicable regulatory standards.
• Perform quality assurance and quality control activities to ensure accuracy, completeness, and audit readiness of assigned studies.
• Develop study tools, source documentation, workflows, and training materials that support effective research operations.
• Communicate and collaborate with investigators, sponsors, monitors, and multidisciplinary teams to support successful study execution.
• Identify and support new clinical research opportunities through interactions with sponsors and research stakeholders.

• Bachelor’s degree in a science, healthcare, or related field
• Six (6) years of direct clinical research experience, including four (4) years supporting oncology clinical research studies

• None

• Extensive knowledge of medical terminology and clinical research practices.
• Thorough understanding of Good Clinical Practice (GCP), HIPAA requirements, and applicable regulatory guidelines governing clinical research.
• Strong ability to interpret and apply study protocols, informed consent requirements, and research-related regulations.
• Advanced organizational skills with the ability to manage multiple studies, priorities, and deadlines simultaneously.
• Strong attention to detail and commitment to data accuracy and quality.
• Proficiency with Microsoft Office applications and electronic data management systems.
• Ability to collect, document, and maintain clinical research data with a high degree of accuracy.
• Effective verbal and written communication skills with the ability to clearly present information to diverse audiences.
• Strong leadership, mentoring, and training skills to support the development of study team members.
• Critical thinking and problem-solving skills with the ability to independently resolve complex research-related issues.
• Ability to collaborate effectively with investigators, sponsors, regulatory personnel, and multidisciplinary teams.
• Ability to develop and improve processes, workflows, training materials, and research documentation.
• Ability to maintain audit readiness and ensure compliance with institutional and regulatory requirements.
• Ability to travel between clinical sites as required.