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Title
Text copied to clipboard!Clinical Trials Coordinator
Description
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We are looking for a Clinical Trials Coordinator to join our research team and oversee the daily operations of clinical studies. This role is essential in ensuring that clinical trials are conducted in accordance with regulatory requirements, ethical standards, and study protocols. The Clinical Trials Coordinator will work closely with principal investigators, research staff, sponsors, and regulatory bodies to manage all aspects of clinical trials from initiation to close-out.
The ideal candidate will have a strong background in clinical research, excellent organizational skills, and the ability to manage multiple projects simultaneously. Responsibilities include participant recruitment, informed consent, data collection and entry, regulatory documentation, and coordination of study visits. The Clinical Trials Coordinator will also be responsible for maintaining compliance with Good Clinical Practice (GCP) guidelines and institutional policies.
This position requires attention to detail, strong communication skills, and the ability to work independently and collaboratively. The Clinical Trials Coordinator plays a critical role in advancing medical knowledge and improving patient care through the successful execution of clinical research studies.
Responsibilities
Text copied to clipboard!- Coordinate and manage day-to-day clinical trial activities
- Recruit and screen study participants according to protocol
- Obtain and document informed consent from participants
- Maintain accurate and complete study records and regulatory documents
- Schedule and conduct study visits and follow-ups
- Ensure compliance with GCP, IRB, and regulatory requirements
- Communicate with sponsors, CROs, and regulatory agencies
- Assist in budget preparation and tracking study expenses
- Monitor data collection and ensure data integrity
- Report adverse events and protocol deviations promptly
- Train and supervise research assistants or coordinators
- Participate in audits and inspections as needed
Requirements
Text copied to clipboard!- Bachelor’s degree in life sciences, nursing, or related field
- 2+ years of experience in clinical research coordination
- Knowledge of GCP, FDA regulations, and IRB processes
- Strong organizational and time management skills
- Excellent written and verbal communication skills
- Proficiency in Microsoft Office and clinical trial software
- Ability to work independently and in a team environment
- Detail-oriented with strong problem-solving abilities
- Certification as a Clinical Research Coordinator (preferred)
- Experience with electronic data capture systems
- Ability to manage multiple studies simultaneously
- Understanding of medical terminology and clinical procedures
Potential interview questions
Text copied to clipboard!- Do you have experience coordinating clinical trials?
- Are you familiar with GCP and FDA regulations?
- Can you describe your experience with participant recruitment?
- Have you worked with electronic data capture systems?
- How do you ensure compliance with study protocols?
- What is your experience with IRB submissions and documentation?
- Can you manage multiple studies at once?
- Have you ever participated in a clinical trial audit?
- What strategies do you use to maintain data integrity?
- Are you certified as a Clinical Research Coordinator?
