Clinical Research Coordinator

Nemours Children's Health•Jacksonville, FL

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 trials. The role supports regulatory documentation, research-team training, participant recruitment and consent or assent, 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 prioritize 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; collect and prepare documents required by sponsors and attend Investigator Meetings as assigned.
Conduct research studies, including emergent access or compassionate use, multisite clinical trials, and investigator-initiated studies; use 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 monitor data integrity, completeness, accuracy, and quality; maintain multiple study databases, submit data proactively, and address queries promptly.
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, following the manual of procedures and sending applicable documentation with samples.
Coordinate sponsor monitoring activities, complete Case Report Forms, respond to sponsor queries, and prepare for sponsor, IRB, FDA, and DHHS audits.
Participate in continuous process-improvement initiatives and implement resulting outcomes.
Prepare for internal and external audits and prepare corrective action plans as indicated.