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, 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. 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 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.
• Other duties as assigned.

Requirements

• Bachelor's degree in Nursing required, Master's degree in Nursing acceptable, demonstrates ability to coordinate and establish priorities among diverse tasks; effectively communicates verbally and in writing.
• Minimum 2 years experience as a Clinical Research Nurse I or Clinical Research Coordinator I.