Clinical Research Coordinator

Socket.dev; Orlando (FL); On-site; USD 52,000 - 70,000; Full time

Job summary

Nemours Children's Health is seeking a Clinical Research Coordinator to support the Clinical Research CORE in Florida. The CRC will implement and complete studies, assist with regulatory documents, recruit participants, obtain consent, educate families, schedule procedures, and maintain detailed study records.

The role requires adherence to SOPs and GCP, data collection and database management, coordination with sponsors and staff, and preparation for audits and sponsor visits.

Qualifications

• Bachelor's degree in medical or science related field required.
• At least one year of Research experience required.
• Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience.

Responsibilities

• Follows SOPs and Good Clinical Practices; prepares documents; attends Investigator Meetings.
• Understands and conducts clinical research studies including multi-site trials and Investigator Initiated studies.
• Participates in parental permission/assent process and schedules visits to comply with protocols.
• Performs clinical data gathering, data integrity checks, and maintains multiple databases.
• Provides training to nursing and ancillary staff and coordinates with departments for protocol compliance.
• Identifies, reports, and follows up on Serious Adverse Events and unanticipated problems.
• Maintains study drug accountability records and coordinates drug administration with the research pharmacist.
• Prepares clinical specimens for shipment to central laboratories and ensures SOPs and documentation accompany samples.
• Coordinates monitoring with Sponsor representatives; completes Case Report Forms and responds to sponsor queries.
• Supports audits and implements continuous process improvements; prepares corrective action plans.

Skills

Verbal and written communication

Study coordination

Microsoft Office

Education

Bachelor's degree in medical or science field

Tools

Microsoft Office

Job description

Nemours is hiring a Clinical Research Coordinator (CRC). This position will support the Clinical Research CORE.

The Clinical Research Coordinator (CRC) 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.

Primary Responsibilities

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.

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

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.