Clinical Research Nurse
About The Position
Nemours is seeking a Clinical Research Nurse to join our team in Orlando, FL. This role supports the Nemours Center for Cancer & Blood Disorders (NCCBD) in Oncology. The Clinical Research Nurse will coordinate, implement, and complete clinical research studies and/or clinical trials. This includes assisting in screening oncology patients, 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, participating in sponsor study monitoring visits, preparing for and participating in internal and external research audits, maintaining various research databases, processing and shipping research samples, and participating in continuous process improvement initiatives.
Requirements
- Associate degree in Nursing required.
- ASN will require obtaining BSN within 3 years of hire date.
- 1-3 years experience.
- Clinical Research Coordinator certification or eligible to sit for exam after 2 years clinical research coordination experience.
Nice To Haves
- Bachelor’s degree in nursing preferred.
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.
- Supports NCCBD’s NCORP: NCI Community Oncology Research Program across the Nemours enterprise.
- 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.
- Attendance at and participation in relevant clinical divisional/departmental activities to assure routine administrative procedures are followed.
- Further attendance at Sponsor Coordinator meetings as needed for study related training.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
