Clinical Research Coordinator: Trials, Data & Compliance

Nemours-Children; Orlando (FL); On-site; USD 45,000 - 70,000; Full time

Job summary

Nemours is seeking a Clinical Research Coordinator to support the Clinical Research CORE. The CRC will implement and complete studies by assisting in regulatory documentation, participant recruitment, parental consent, and educating parents and participants.

The role includes scheduling visits, data collection, maintaining records, coordinating with sponsors, and supporting audits. Collaboration with research teams and adherence to SOPs/GCPs are essential for success.

Qualifications

• Bachelor’s degree in medical or science related field.
• At least one year of research experience.
• Effective verbal and written communication; ability to coordinate among diverse tasks.
• CRC certification or eligible to sit for exam after 2 years clinical research coordination experience.

Responsibilities

• Follows SOPs and GCPs; prepares documents for sponsor and regulatory needs; attends Investigator Meetings as assigned.
• Understands conduct of clinical studies including emergent access/compassionate use and Investigator Initiated studies.
• Manages parental permission/assent processes; schedules visits and ensures protocol compliance.
• Performs data gathering, measurements, and data integrity checks; maintains study databases; addresses sponsor queries.
• Trains nursing and ancillary staff, builds cross-department relationships to ensure protocol compliance.
• Identifies and reports Serious Adverse Events or unanticipated problems; works with research pharmacist for drug documentation.
• Maintains drug accountability records and coordinates drug administration and documentation with sponsor.
• Prepares specimens for shipment to central labs; ensures SOPs followed and proper documentation accompanies samples.
• Coordinates monitoring activities with Sponsor; completes Case Report Forms and responds to sponsor queries; prepares for audits by sponsor/IRB/FDA.
• Engages in continuous process improvement and supports audit readiness and corrective actions.
• Prepares for internal and external audits with corrective action plans.

Skills

Communication skills

Education

Bachelor’s degree in medical or science related field

Tools

Microsoft Office

Job description

Nemours is seeking a Clinical Research Coordinator to support the Clinical Research CORE. The CRC will implement and complete studies by assisting in regulatory documentation, participant recruitment, parental consent, and educating parents and participants.

The role includes scheduling visits, data collection, maintaining records, coordinating with sponsors, and supporting audits. Collaboration with research teams and adherence to SOPs/GCPs are essential for success.