Clinical Research Coordinator Emergency Dept.
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Job Location:
Wilmington, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Nemours is seeking a Clinical Research Coordinator to join our Nemours Childrens Health team in Wilmington DE.
The Clinical Research Coordinator coordinates implements and completes clinical research studies and/or clinical trials in the Emergency Department at Nemours Childrens Hospital Delaware 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.
***Schedule will be 40 hours/week with rotating day and evening shifts between 8am-10pm M-F and 2-10pm Sundays.***
Essential Functions
- 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 manual of procedures is followed and applicable documentation is sent with samples
- Coordinates monitoring activities with Sponsors 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.
Requirements
- Bachelors 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
Required Experience:
IC
About Company
Nemours Children’s Health is an internationally recognized children’s health system. With more than 1.7 million patient encounters annually, we provide medical care in five states through two freestanding state-of-the-art children’s hospitals — Nemours Children’s Hospital, Delaware an ... View more
