Clinical Research Coordinator
Nemours
- Jacksonville, FL
- Permanent
- Full-time
- Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals
- Participates in the conduct of parental permission/assent process for assigned studies; schedules study visits with study participants in accordance with study protocols; develops strategies to assure compliance of study participants with protocol requirements.
- Performs clinical data gathering, measurements and monitoring of data integrity, including data completeness, accuracy and quality. Maintains multiple study databases. Ability to be submit data proactively and address queries in a timely manner.
- Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
- Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
- Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
- Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
- Coordinates monitoring activities with Sponsor's representative(s). Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.
- Participates in continuous process improvement initiatives and implementation of outcomes
- Prepares for internal and external audits. Prepares corrective action plans as indicated.
- Bachelor's degree in medical or science related field required; effectively uses Microsoft computer software; demonstrates ability to coordinate and establish priorities among diverse tasks; effectively communicates verbally and in writing
- Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience