About this role
Under limited supervision the Clinical Research Coordinator (CRC) - Senior champions patient safety and protocol integrity while upholding the highest standards of patient care. The CRC communicates effectively to support the successful conduct of clinical trials and ensure quality outcomes. Responsibilities include screening and scheduling patients, coordinating all on-study activities, and maintaining compliance with study requirements. The CRC also participates in study teleconferences with sponsors and clinical research organizations to promote clear communication and continuity of information.
Education: Bachelors degree is required.
- Advanced ability to communicate and liaise with research participants, research team members, and other relevant partner/key stakeholders.
- Shown ability to organize and coordinate work within schedule constraints and handle emergent requirements in a timely manner.
- Advanced ability to monitor important and complex projects concurrently.
- Advanced knowledge of Federal regulations and ethical standards governing human subjects research (e.g., FDA, HIPAA, IRB processes).
- Advanced understanding of Clinical trial design, methodology, and protocol requirements.
- Knowledgeable in Medical terminology, anatomy, and disease processes relevant to assigned studies.
- Advanced knowledge of adverse event reporting procedures and documentation standards.
- Adept understanding of the principles of informed consent and patient rights.
- Proven ability to use Electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Shown ability to adhere to Institutional policies and standard operating procedures (SOPs).
- Skilled at patient screening, recruitment, and informed consent processes.
- Shown ability to conduct and document study visits according to protocol.
- Advanced problem-solving and critical thinking for protocol deviations or logistical challenges.
- Shown collaboration and teamwork in multidisciplinary clinical and research environments.