- Evaluate subjects for research studies by performing and documenting detailed histories and physical exams.
- Ensure that clinical trials and studies are run according to requirements and regulatory procedures.
- Focus on the care of research study patients with regard to each study's safety and protocol.
- Ensure all data is accurately documented, such as patient vitals and times medications were administered.
- Serve as a resource person to subjects and staff for questions regarding study protocols and eligibility requirements.
- Assist with subject screening and recruitment/retention.
- Interpret laboratory results, EKG's and notify subjects and Principal Investigator (PI) of abnormal values/findings.
- Assess subjects for adverse events, serious adverse events, determine causality, and fill out appropriate paperwork for International Review Board (IRB) and sponsor notification.
- Responsible for gathering necessary information from the research participants (i.e. HIPAA, Medical Chart Release Authorization, Questionnaires).
- Responsible for the Informed Consent Process per the Standard Operating Procedures (SOP's).
- Responsible for reviewing inclusion and exclusion criteria for the Principal Investigator (PI).
- Responsible for completing all study specific procedures according to the study protocol.
- Review subject's information in preparation for the investigator's review.
- Responsible for completing source documents and assisting the study coordinator with data transcription onto the Case Report Form (CRF)
Education and Experience:
- A minimum of two (2) year of clinical nursing experience
- California Register Nurse (RN) or Physician Assistant (PA) License is required
- Must have completed Nurse Practitioner Program