Clinical Research Coordinator

Nemours-Children; Jacksonville (FL); On-site; USD 55,000 - 75,000; Full time

Job summary

Nemours-Children in Jacksonville, FL is seeking a Clinical Research Coordinator to implement and complete clinical studies. You will assist in regulatory documents, educate families, schedule procedures, and maintain study data across multiple databases.

The role requires a Bachelor's degree in a medical or science field and CRC certification or eligibility after two years of coordination experience. Strong communication and organizational skills are essential for success.

Qualifications

• Bachelor’s degree in medical or science field is required.
• Proficient with Microsoft software; able to coordinate and prioritize tasks; strong written and verbal communication.

Responsibilities

• Follows SOPs and GCP; prepares and manages regulatory documents; coordinates with study teams and sponsors.
• Recruits participants, obtains consent/assents, educates families, and schedules study visits.
• Collects and records data; maintains study databases; addresses sponsor queries and audits.

Skills

Microsoft Office

Coordination

Communication

Education

Bachelor's degree in medical or science field

Tools

Clinical Research Coordinator certification

Job description

Nemours is seeking a Clinical Research Coordinator to join our team in Jacksonville, FL.

Coordinates, implements and completes clinical research studies and/or clinical trials by assisting in regulatory document preparation and collection, in-servicing research teams, recruiting study participants, obtaining parental permission/assent/consent forms, educating parents/participants, scheduling and conducting study procedures, collecting and recording study data, maintaining detailed study records, interfacing with study sponsors, participation in sponsor study monitoring visits, prepare for and participate in internal and external research audits, maintain various research databases.

Essential Functions:

• 1. Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned.
• 2. 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
• 3. 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.
• 4. 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.
• 5. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
• 6. Assists in identifying, reporting and following-up on Serious Adverse Events and/or Unanticipated problems
• 7. Assists in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
• 8. Prepares clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
• 9. 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.
• 10. Participates in continuous process improvement initiatives and implementation of outcomes
• 11. Prepares for internal and external audits. Prepares corrective action plans as indicated.

Requirements:

• 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