Clinical Research Nurse

4 weeks ago

Palo Alto, California, United States PAVIR Full time

Job Summary
Palo Alto Veterans Institute for Research (PAVIR) is seeking a full-time Clinical Research Nurse - TMS to support a VA cooperative clinical study in the division of Psychiatry. The study evaluates the effectiveness of repetitive transcranial magnetic stimulation (rTMS) as a treatment for Treatment Resistant Major Depression (TRMD).

Responsibilities
Assist in the initiation of new studies, including submission of required regulatory documents to IRB and R & D committees and subcommittees. Work directly with site investigator(s), study coordinator, and other facility staff. Oversee the day-to-day activities of the project and act as the resource person for all questions about the study activities locally. Maintain a high level of knowledge and understanding of the study protocol, including all requirements for patient visits, obtaining informed consent, patient visit schedules, test procedures, laboratory information, and device accountability requirements. Assist in the selection, contacting, and scheduling of potential research subjects. Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the study protocol. Provide education and instruction on rTMS treatment and possible adverse effects. Perform venipunctures for collection of blood samples required by study protocol, including processing of samples and proper shipment per regulatory guidelines. Collects and maintains accurate source documentation for each study participant. Accurately documents in CPRS, completes data entry, and responds to sponsor queries. Initiates physician orders and creates source documents. Maintains regulatory documents and sponsor files. Assure confidentiality and security of human participants and data collected in accordance with HIPAA regulations. Adheres to Federal Privacy regulations. Acts to protect the rights, safety, and well-being of human participants involved in clinical trials. Complies with ethical standards for research conduct. Fosters collaborative research relationships using excellent communication and interpersonal skills with investigators and participants. Interact with Site Investigator as needed to ensure patients receive appropriate medical and psychiatric evaluation and care when needed. Alerts Site Investigator of adverse events when appropriate. Other tasks as assigned.

Qualifications
Graduate of a school of professional nursing or medical school. Valid Driver License required. RN license required. 1 year or more of nursing experience. Preferred: Approved by the appropriate State-accrediting agency. Previous experience in a clinical and research environment. Experience with grants and contracts function, clinical trial, and research data management. Good understanding of clinical terminology and procedures gained through experience. Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. Ability to read and understand study/trial protocol. Ability to prioritize and organize a high-volume workload and adapt to changing priorities. Demonstrated ability to work independently and cooperatively. Demonstrated ability to work and communicate effectively with study subjects. Proven track record towards meeting goals and deadlines. Strong interpersonal skills. Proficiency with Microsoft Office and database applications is preferred. Knowledge of VA and its health care system regarding clinical research trials and understanding of VA procedures and safety regulations is strongly desired. Some clinical device experience is preferred. Knowledge of and experience working in orthopedic research is desired. Knowledge of medical terminology is strongly preferred.

About PAVIR
PAVIR facilitates research and education activities conducted at the VA Palo Alto Health Care System. At PAVIR, we work with more than 160 uniquely talented medical scientists. We recruit and retain talented employees who believe in making a difference in the lives of others through innovative health research.

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