Clinical Research Coordinator

Primary Responsibilities

• 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
• 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 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.

Qualifications

• Bachelor's degree in medical or science related field required
• At least one year of Research experience 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

About Us

Nemours Children's Health is an internationally recognized pediatric health system serving more than 1.7 million patient encounters each year. We deliver care across six states through two freestanding children's hospitals — Nemours Children's Hospital, Delaware and Nemours Children's Hospital, Florida — along with a network of more than 80 primary, urgent, and specialty care practices and more than 40 hospital partnerships. Backed by the Nemours Foundation and Alfred I. duPont Trust, our $1.7B nonprofit system is dedicated to improving children's health through clinical care, research, education, advocacy, and prevention. Our Whole Child Health approach focuses equally on prevention and treatment, partnering with communities to help every child thrive. Inclusion and belonging guide our strategy and growth. We are committed to culturally relevant care, reducing health disparities, and fostering an environment where every associate, patient, and family feels supported and valued. Learn more at Nemours.org.