Clinical Research Coordinator

The Nemours Foundation • Jacksonville, FL

6d

About The Position

Nemours is seeking a Clinical Research Coordinator to join its team in Jacksonville, Florida. The Clinical Research Coordinator implements and completes clinical research studies and clinical trials. The role supports regulatory document preparation and collection, research-team training, participant recruitment and permission/assent/consent, participant education, study scheduling and procedures, data collection and recording, study-record maintenance, sponsor communications and monitoring visits, audits, and research databases.

Requirements

• Bachelor’s degree in a medical- or science-related field.
• At least one year of research experience.
• Effective use of Microsoft computer software.
• Ability to coordinate and establish priorities among diverse tasks.
• Effective verbal and written communication skills.

Nice To Haves

• 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 in conducting clinical research.
• Collect and prepare documents required by sponsoring agencies and attend Investigator Meetings as assigned.
• Conduct studies involving, among other areas, emergent access or compassionate use, multisite clinical trials, investigator-initiated studies, and research-team training manuals.
• Participate in the parental permission, assent, and consent process for assigned studies.
• Schedule study visits according to study protocols and develop strategies to support participant compliance with protocol requirements.
• Gather clinical data and measure and monitor data integrity, including completeness, accuracy, and quality.
• Maintain multiple study databases, submit data proactively, and address queries in a timely manner.
• Train nursing and ancillary study staff for study purposes and build relationships with departments to support protocol compliance.
• Assist with identifying, reporting, and following up on Serious Adverse Events and Unanticipated Problems.
• Assist with study medication accountability records and coordinate study drug administration and documentation with the research pharmacist.
• Prepare clinical specimens for shipment to central laboratories, follow the manual of procedures, and send applicable documentation with samples.
• Coordinate monitoring activities with sponsor representatives.
• 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 outcomes.
• Prepare for internal and external audits and prepare corrective action plans as indicated.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level