Clinical Research Coordinator jobs in United States
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Nemours Children's Health · 8 hours ago

Clinical Research Coordinator

Nemours Children's Health is an internationally recognized children’s health system. They are seeking a Clinical Research Coordinator to coordinate and implement clinical research studies in the Orthogenetics Department, including regulatory document preparation, participant recruitment, and data collection.

AssociationHealth Care

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 be 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

Qualification

Clinical researchRegulatory document preparationData integrity monitoringMicrosoft softwareCommunication skills

Required

Bachelor's degree in medical or science related field required
1-3 years research experience
Effectively uses Microsoft computer software
Demonstrates ability to coordinate and establish priorities among diverse tasks
Effectively communicates verbally and in writing

Company

Nemours Children's Health

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Nemours Children's Health is committed to improving the health of children.

Funding

Current Stage
Late Stage
Total Funding
$10.5M
Key Investors
National Institutes of Health
2021-09-21Grant· $10.5M

Leadership Team

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Mark Mumford
EVP, Chief Operating Officer, Nemours Children's Health
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Kevin Haynes
Chief Privacy Officer
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