Clinical Research Coordinator

Minimum Qualifications

• Bachelor’s degree in a health-related field such as Nursing, Life Sciences, or Public Health.
• At least 2 years of experience coordinating clinical research studies or trials.
• Comprehensive knowledge of clinical trial processes, regulatory requirements, and ethical standards.
• Familiarity with clinical research documentation, including informed consent forms and case report forms.
• Strong organizational skills and attention to detail to manage multiple study activities simultaneously.

Preferred Qualifications

• Certification as a Clinical Research Coordinator (e.g., ACRP-CRC or SOCRA).
• Experience working with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Advanced knowledge of FDA regulations and Institutional Review Board (IRB) processes.
• Previous experience in patient recruitment and retention strategies for clinical studies.
• Master’s degree in Clinical Research, Public Health, or a related discipline.

Responsibilities

• Coordinate and oversee the daily operations of clinical trials, including patient recruitment, informed consent, and scheduling study visits.
• Ensure compliance with all regulatory requirements, institutional policies, and Good Clinical Practice (GCP) guidelines throughout the study lifecycle.
• Maintain accurate and up-to-date regulatory documents, case report forms, and study databases to support data integrity and audit readiness.
• Monitor study progress and patient safety by conducting regular assessments and reporting adverse events to the appropriate parties.
• Collaborate with investigators, sponsors, and multidisciplinary teams to facilitate effective communication and resolve study-related issues promptly.

Skills

• The required skills such as clinical trials coordination, regulatory document management, and patient recruitment are essential for ensuring that studies are conducted efficiently and ethically.
• Clinical monitoring and trial management skills enable the coordinator to oversee study progress and maintain compliance with protocols and regulations.
• Proficiency in clinical research and clinical practice allows the coordinator to understand medical terminology and patient care considerations, facilitating effective communication with healthcare providers and participants.
• Preferred skills like experience with electronic data systems and advanced regulatory knowledge enhance the ability to manage complex data and navigate regulatory landscapes.
• Together, these skills support the daily responsibilities of maintaining study integrity, safeguarding participant safety, and contributing to the advancement of healthcare research.