Company Name:
Sutter Health
Approximate Salary:

Location:
San Francisco, California
Country:
United States
Industry:
Research
Position type:
Experience level:
Education level:

Clinical Research Nurse Coordinator-Research Institute

Description:

JOB SUMMARY\:

The Clinical Research Nurse Coordinator carries out the regulatory and protocol requirements of research studies.

Maintains thorough familiarity of individual protocol procedures/requirements for which the position is primarily responsible.

Utilizes nursing skills to evaluate participants for entry into studies based on individual protocol inclusion and exclusion requirements. Participates in the informed consent process by presenting studies to potential participants, answering questions, and obtaining the proper signatures. Communicates on a regular basis with the principal investigator or sub-investigators regarding the status of participants in the trial.

Completes case report forms as required. Provides source documentation and participant records, as required. Conducts participant interviews regarding compliance with medication schedule, elicits and documents information regarding adverse events and concurrent medications in accordance with protocol requirements.

Completes proper insertion of IV catheter.  Draws blood from IV catheter. Ensures accurate and aseptic IV placement.

Functions as a member of a research team communicating with other team members for the efficient management of study participants and acts as a medical resource for non-medical research team members.

Functions as an advocate for participants providing support as a liaison between the participant, Principal Investigator, Medical Center, and study sponsors as the need arises. Maintains knowledge of current regulatory requirements of studies and tenants of “Good Clinical Practice”. Carries out study responsibilities in compliance with Institutional Standard Operating Procedures.

Ensures accurate dispensing of study medication in compliance with individual protocols.

Ensures accurate and timely data collection as transcribed onto case report forms as required by individual study protocols.  Maintains complete source documentation on each study subject as required by study. Prepares and maintains study regulatory documents.  Submits SAEs, IND safety reports and progress reports on time to assure continuing project approval as required by the CPMC IRB guidelines and applicable regulatory agencies.

Attends protocol start-up meetings and ongoing trainings as needed.

Conducts staff in-services related to studies. Functions as a medical resource for study research technicians. Available for and facilitates study monitoring visits.

Qualification:

Licensures & Certifications\:

Registered Nurse - State LIcensure required

 

Skills & Knowledge\:

Knowledge of the design and conduct of studies with the appropriate nursing skills required to perform functions of the position.

Strong written and verbal language skills.