Clinical Research Coordinator
About The Position
Nemours is seeking a Clinical Research Coordinator to join its team in Jacksonville, Florida. The coordinator supports and completes clinical research studies and trials, including regulatory document preparation and collection, research team training, participant recruitment and consent processes, study visit scheduling and procedures, data collection and recordkeeping, sponsor communications and monitoring visits, audit preparation, and maintenance of research databases. The role follows Standard Operating Procedures and Good Clinical Practices and may involve compassionate-use or emergent-access studies, multisite clinical trials, and investigator-initiated research. The coordinator works with participants and families, nursing and ancillary staff, sponsors, research pharmacists, laboratories, and other departments to support protocol compliance and study quality.
Requirements
- Bachelor’s degree in a medical- or science-related field.
- Effective use of Microsoft computer software.
- Ability to coordinate and establish priorities among diverse tasks.
- Effective verbal and written communication skills.
- Clinical Research Coordinator certification, or eligibility to sit for the exam after two years of clinical research coordination experience.
Responsibilities
- Follow Standard Operating Procedures and Good Clinical Practices; collect and prepare documents required by sponsoring agencies and attend assigned Investigator Meetings.
- Conduct studies involving emergent access or compassionate use, multisite clinical trials, and investigator-initiated research; work with research team training manuals.
- Participate in parental permission, assent, and consent processes; schedule study visits according to protocols and develop strategies to support participant compliance.
- Gather clinical data and measurements, monitor data integrity, and maintain multiple study databases; submit data proactively and address queries in a timely manner.
- Train nursing and ancillary study staff and build relationships with departments to support protocol compliance.
- Assist with identifying, reporting, and following up on Serious Adverse Events and unanticipated problems.
- Assist in maintaining study medication accountability records and coordinate study drug administration and documentation with the research pharmacist.
- Prepare clinical specimens for shipment to central laboratories and follow manuals of procedures, including required sample documentation.
- Coordinate sponsor monitoring activities, complete Case Report Forms, respond to sponsor queries, and prepare for sponsor, IRB, and FDA/DHHS audits.
- Participate in continuous process improvement initiatives and implement resulting outcomes.
- Prepare for internal and external audits and prepare corrective action plans when indicated.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
