Job Description: Clinical Research Coordinator (CRC)
Position: Clinical Research Coordinator (CRC)
Department: Healthcare and Medicine > Medical Research
Reports to: Clinical Research Manager
Job Overview:
The Clinical Research Coordinator (CRC) plays a vital role in the planning, implementation, and coordination of clinical research studies. The CRC collaborates with medical professionals, research staff, and sponsors to ensure the successful execution of clinical trials within a healthcare or medical research setting. This position requires exceptional organizational skills, attention to detail, and the ability to effectively communicate with various stakeholders.
Responsibilities:
1. Coordinate and execute clinical research studies, ensuring compliance with study protocols, regulatory requirements, and ethical guidelines.
2. Assist in the development of study protocols, informed consent forms, and other research-related documents as required.
3. Recruit, screen, and enroll eligible participants for clinical trials, adhering to established inclusion and exclusion criteria.
4. Conduct participant assessments, collect and accurately record research data, and maintain study documentation in accordance with applicable regulations.
5. Organize and schedule study visits, procedures, and follow-up appointments, ensuring timely completion of required assessments and interventions.
6. Coordinate with study sponsors, investigators, and research teams to ensure smooth study implementation, including the ordering and management of investigational products and supplies.
7. Communicate effectively with participants, providing education and addressing any concerns or questions related to the study.
8. Collaborate with study monitors and regulatory authorities during audits and inspections, ensuring compliance with Good Clinical Practice (GCP) guidelines.
9. Assist in the preparation and submission of regulatory documents and applications for institutional review board (IRB) approval.
10. Maintain accurate and up-to-date study records, databases, and electronic systems used for data collection and management.
11. Participate in relevant research meetings, training sessions, and continuing education programs to enhance knowledge and skills in clinical research.
Qualifications:
1. Bachelor's degree in a related field (e.g., life sciences, nursing, or healthcare administration).
2. Minimum of 2 years of experience as a Clinical Research Coordinator or similar role within a healthcare or medical research setting.
3. Proficient knowledge of clinical research regulations, guidelines, and ethics (e.g., FDA regulations, ICH-GCP).
4. Strong understanding of medical terminology and the ability to interpret and apply complex study protocols.
5. Excellent organizational and time management skills, with the ability to prioritize multiple tasks and meet deadlines.
6. Detail-oriented mindset with exceptional accuracy in data collection, documentation, and record management.
7. Effective communication skills, both written and verbal, to interact with participants, investigators, sponsors, and research team members.
8. Proficiency in using electronic data capture (EDC) systems and other relevant software applications.
9. Demonstrated ability to work independently and collaboratively in a team-based environment.
10. Knowledge of basic medical procedures and ability to conduct clinical assessments is preferred.
Note: The above job description is not exhaustive and may be subject to change based on organizational needs and requirements.