Rn Jobs in Bay Area

About The Position

Requirements

• Degree in life sciences or health sciences, such as Registered Nurse (R.N.), Doctor of Philosophy (Ph.D.), Medical Doctorate (M.D.), or another related degree.
• Two or more years of clinical research experience.
• Strong verbal and written communication skills.
• Annual completion of the NIH Protection of Human Subjects online course is required.
• IATA training is required every two years.

Nice To Haves

• Research certification through a recognized national organization such as SOCRA or ACRP is encouraged.

Responsibilities

• Support study feasibility, regulatory submissions, and study initiation activities.
• Apply knowledge of study design to evaluate protocol feasibility at the site.
• Assist Regulatory staff with preparing and submitting documents to the Institutional Review Board (IRB).
• Participate in study site initiation activities and attend investigator meetings and clinical trial conferences as directed.
• Document protocol deviations and exemptions.
• Prepare for and participate in FDA inspections.
• Communicate with IRBs, sponsors, investigators, and research team members.
• Participate in patient recruitment and evaluate patient eligibility.
• Review and verify source documents and inclusion and exclusion criteria to confirm study eligibility.
• Interview potential study subjects to assess their ability and willingness to complete study procedures.
• Maintain patient screening and enrollment logs.
• Explain protocol requirements, informed consent, and follow-up procedures to potential study subjects.
• Follow study randomization procedures and provide patient-centered communication and customer service.
• Coordinate study visits and perform clinical procedures while ensuring protocol compliance.
• Ensure study drugs are dispensed according to protocol, maintain drug accountability records, and review and document returned drugs.
• Provide direct care related to study compliance throughout the research experience.
• Perform peripheral venipuncture according to organizational standards.
• Collect, batch, process, and ship specimens according to protocol; collaborate with site staff on specimen processing.
• Obtain test results and report them to the physician investigator.
• Attend clinic visits with the investigator and assist with following study guidelines.
• Obtain and review original source documents, including recordings, scans, test results, and procedure reports.
• Abstract data from medical records and other documentation to study forms and flow sheets.
• Complete and maintain study documentation and case report forms, and resolve data queries.
• Schedule sponsor monitoring visits and prepare case report forms and source documents for sponsor and audit review.
• Assist with audit preparation and monitoring visits.
• Participate in educational and training activities and continuing education.
• Support management team projects and assist with maintaining budgetary data for each clinical trial.
• Assist with planning department coverage for clinic visits, data management, and meetings.
• Maintain professional communication with internal and external customers.