Clinical Research Nurse
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Job Location:
Pensacola, FL - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
The Clinical Research Nurse coordinates 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. Performs nursing procedures: IV placement administration of investigational agents through IV or Subcutaneous or Intramuscular injections.
Essential Functions:
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
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
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.
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.
in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.
in identifying reporting and following-up on Serious Adverse Events and/or Unanticipated problems
in the maintenance of study medication accountability records; works closely with research pharmacist to coordinate study drug administration and documentation
clinical specimens for shipment to central laboratories. Ensures manual of procedures is followed and applicable documentation is sent with samples
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.
in continuous process improvement initiatives and implementation of outcomes
for internal and external audits. Prepares corrective action plans as indicated
Qualifications:
- Florida Nursing License Required.
- Bachelors degree in Nursing preferred; Associate degree in Nursing will require obtaining BSN within 3 years of hire date;
- Effectively uses Microsoft computer software;
- Demonstrates ability to coordinate and establish priorities among diverse tasks
- Effectively communicates verbally and in writing
Required Experience:
IC
Key Skills
- Clinical Research
- FDA Regulations
- Data Collection
- GCP
- Infusion Experience
- Phlebotomy
- Clinical Trials
- Pediatrics Experience
- Qualitative Research Interviewing
- Research Experience
- Nursing
- Epic
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
