Clinical Research Nurse II

Nemours in; Orlando (FL); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading healthcare organization is seeking a Clinical Research Nurse II to coordinate and implement clinical research studies. The role involves performing nursing procedures, ensuring protocol compliance, and maintaining study records. Ideal candidates will have a Bachelor's degree in Nursing and a minimum of 2 years of experience in clinical research.

Qualifications

• Bachelor's degree in Nursing required.
• Minimum 2 years experience as Clinical Research Nurse I or Clinical Research Coordinator I.
• Ability to prioritize tasks and communicate effectively.

Responsibilities

• Coordinates and implements clinical research studies.
• Maintains study medication accountability records.
• Participates in training nursing and ancillary study staff.

Skills

Communication

Data Integrity Monitoring

Clinical Research Procedures

Education

Bachelor's degree in Nursing

Master's degree in Nursing

Job description

Clinical Research Nurse II (Finance)

The Clinical Research Nurse II 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, participating in sponsor study monitoring visits, preparing for and participating in internal and external research audits, and maintaining various research databases. Performs nursing procedures such as IV placement and administration of investigational agents through IV or Subcutaneous or Intramuscular injections. Serves as a mentor to research team members and investigators.

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 are not limited to, Emergent Access/Compassionate use, Multi-site clinical trials, Investigator Initiated studies, and Research Team training manuals.
• Participates in the conduct of parental permission/assent processes for assigned studies; schedules study visits with participants according to protocols; develops strategies to ensure protocol compliance.
• Performs clinical data gathering, measurements, and monitoring of data integrity, including completeness, accuracy, and quality; maintains multiple study databases; proactively submits data and addresses queries promptly.
• Participates in training nursing and ancillary study staff; builds relationships with departments to ensure protocol adherence.
• Assists in identifying, reporting, and following up on Serious Adverse Events and Unanticipated Problems.
• Maintains study medication accountability records; collaborates with research pharmacists for drug administration and documentation.
• Prepares clinical specimens for shipment to central laboratories, following procedures and ensuring documentation accompanies samples.
• Coordinates monitoring activities with Sponsor representatives; completes Case Report Forms; responds to sponsor queries; prepares for audits by sponsors, IRB, and regulatory agencies.
• Participates in process improvement initiatives and implements outcomes.
• Prepares for audits and develops corrective action plans as needed.
• Performs other duties as assigned.

Requirements

• Bachelor's degree in Nursing required; Master's degree in Nursing acceptable; demonstrates ability to prioritize tasks and communicate effectively both verbally and in writing.
• Minimum of 2 years experience as a Clinical Research Nurse I or Clinical Research Coordinator I.