Turkey Creek Medical Center

Job Summary

The Clinical Research Coordinator, Senior functions as a key member of a multidisciplinary clinical research team responsible for independently coordinating a portfolio of complex clinical research studies. This role manages the regulatory, financial, and operational aspects of assigned trials, ensuring strict compliance with protocol requirements and applicable regulations. The Senior Coordinator also supports quality oversight, serves as a resource to junior staff, and facilitates collaboration across study teams, sponsors, and regulatory bodies. The incumbent must demonstrate strong critical thinking, organizational skills, and the ability to manage competing priorities with minimal supervision.

Essential Functions

• Coordinates the full lifecycle of assigned clinical research studies, including regulatory submissions, budget development, data collection planning, safety reporting, and completion of FDA and sponsor-required documentation, ensuring compliance with GCP and other applicable standards.
• Serves as a liaison between investigators, study teams, sponsors, CROs, and Corporate Research Operations, facilitating communication around protocol feasibility, enrollment strategies, safety concerns, and financial matters.
• Performs subject screening, informed consent, clinical assessments, and study procedures in alignment with licensure, scope of practice, and protocol delegation. Manages ongoing subject care, triage, follow-up, discharge planning, and documentation of study-related activities.
• Provides clinical nursing support to research participants when applicable, including medication administration, assessment of abnormal findings, and coordination of care. Delegates nursing activities based on patient needs and staff capabilities.
• Maintains expert knowledge of assigned protocols and regulatory requirements. Ensures compliance with IRB, FDA, NIH, SOPs, Clinical Trial Agreements, and other governing bodies. Prepares for and responds to internal or external monitoring and audit visits.
• Develops, updates, and maintains regulatory documentation including CVs, licenses, and site/lab certifications. Submits IRB and peer review materials and maintains all relevant data in the Clinical Trial Management System (CTMS).
• Conducts quality assurance reviews of regulatory files, identifies deficiencies, and assists with corrective actions. Prepares for audits and participates in follow-up activities.
• Supports onboarding and training for new research personnel, and may serve as a backup to the Clinical Research Supervisor or Coordinator roles as needed.
• Maintains effective and professional communication with patients, family members, research staff, and stakeholders, demonstrating sensitivity to cultural, age-specific, and confidentiality considerations.
• Ensures all required certifications and training are current, including Human Subjects Protection, Good Clinical Practice (GCP), and IATA (International Air Transport Association) training.
• Performs other duties as assigned.
• Maintains regular and reliable attendance.
• Complies with all policies and standards.

Qualifications

• 5-7 years of clinical experience required
• 5-7 years of clinical research experience required

Knowledge, Skills and Abilities

• Strong understanding of federal regulations and GCP requirements.
• Excellent organization, problem-solving, and communication skills.
• Ability to manage complex clinical trials independently.
• Proficiency in CTMS systems, Google Suite, and Microsoft Office Suite.
• Ability to mentor others and contribute to continuous process improvement.
• Familiarity with laws, regulations, and guidance from Federal, State, Local, and Institution, related to clinical research involving human subjects.
• Excellent written and verbal communication skills.
• Ability to review detailed data and make prompt judgments based on that data.
• Ability to work efficiently and effectively under tight deadlines, interruptions, and high work volume.
• Possess effective leadership and critical thinking skills, and be capable of decisive judgment.
• Meets clinical competency requirements.
• Self-directed with demonstrated ability to work independently, as well as with a team
• Interact effectively and pleasantly with a diverse population.
• Bilingual (Spanish) is beneficial.

Licenses and Certifications

• RN - Registered Nurse - State Licensure and/or Compact State Licensure required
• BCLS - Basic Life Support current or obtained within 12 months of employment required
• CCRP - Certified Clinical Research Professional issued by ACRP or obtained within 12 months of employment preferred