Clinical Research Nurse Practitioner/Clinical Research Nurse - Vaccine Trials Unit

Organization
Fred Hutchinson Cancer Research Center & Seattle Cancer Care Alliance
Job Location
Seattle, WA
Job Description

Cures Start Here. At Fred Hutchinson Cancer Research Center, home to three Nobel laureates, interdisciplinary teams of world-renowned scientists seek new and innovative ways to prevent, diagnose and treat cancer, HIV/AIDS and other life-threatening diseases. Fred Hutch's pioneering work in bone marrow transplantation led to the development of immunotherapy, which harnesses the power of the immune system to treat cancer with minimal side effects. An independent, nonprofit research institute based in Seattle, Fred Hutch houses the nation's first and largest cancer prevention research program, as well as the clinical coordinating center of the Women's Health Initiative and the international headquarters of the HIV Vaccine Trials Network. Careers Start Here.

The Seattle VTU, is one of the 23 domestic and international clinical trials units within the HIV Vaccine Trials Network (HVTN). This network is funded to conduct phase I, II, and III clinical trials designed to test the safety and efficacy of HIV Vaccines. Located on First Hill, the Seattle Vaccine Trials Unit (VTU) is a joint research program between the FHCRC and the University of Washington. Since 1987, the Seattle VTU has worked with local community members who are interested in participating in HIV vaccine clinical trials and has provided HIV education to the local community. As a clinical research site, the VTU is responsible for the recruitment, selection, and enrollment of local volunteers, immunization and clinical monitoring of the clinical trial participants, and manages follow-up care for trial participants. The unit also enrolls participants in a number of observational studies that aim to address specific scientific questions related to HIV prevention and immunology. In addition, the unit conducts clinical trials of investigational agents being studied for the prevention and/or treatment of other infectious diseases.

The Clinical Research Nurse (RN)/Nurse Practitioner (ARNP) plans, coordinates, and implements clinical research studies involving human subjects for the Immunology & Vaccine Development research program. The primary focus of the Clinician is screening, enrolling, and following study participants. The incumbent works under the supervision of the Principal Investigator as part of a clinical research team including the VTU physicians, other clinicians, and other unit personnel. The position requires the performance of responsibilities with a high level of independence within the scope of study protocol(s) and guidelines.

Major duties:
- Determine patient study eligibility, obtain informed consent, and initiate patient randomization and enrollment in research studies in accordance with regulatory and GCP guidelines and institutional policy.
- Provide a complete explanation of a study to potential volunteers so as to obtain informed consent.
- Record and evaluate medical, social and sexual histories.
- Draw blood for screening labs and interpret the results for inclusion/exclusion criteria for our studies as well as for medical follow-up if needed.
- Provide HIV pre and post test counseling.
- Provide risk reduction counseling for the prevention of HIV, hepatitis and other sexually transmitted diseases.
- Provide pregnancy prevention counseling for women, including contraceptive counseling as needed.
- Perform complete physical exams on male and female volunteers.
- Follow the complete study protocol for each participant visit.
- Help to maintain the compliance of volunteers to their study regimen.
- Maintain appropriate source documentation, and complete case report forms. Assist with compilation and presentation of status reports to Principal Investigator (PI), clinical research team, and sponsors.
- Provide various forms of health education to study volunteers and provide appropriate referrals to community medical, social, substance abuse and mental health programs if needed.
- Provide support for community education and recruitment with the VTU community educator, recruitment coordinator, and recruiters.
- Collect and assemble data for various research studies.
- Perform clinical procedures including vital signs, vaccine administration, blood draws.
- Assist the Clinic Coordinator in managing the daily operations of a research study.
- Act as a clinical liaison for designated protocols with clinical teams, participants, other institutions, the HIV Vaccine Trials Network, and pharmaceutical companies. Educate clinical teams, ancillary departments, participants, and families about protocols to ensure safe and accurate implementation in compliance with protocol requirements.
- Assist Clinic Coordinator in developing tools for study implementation including data collection tools and study reference materials. Assist Clinic Coordinator in developing orders for protocols to reflect the actions needed to implement all stages of the protocol.
- Identify, assess, and report adverse events in accordance with protocol and regulatory guidelines and institutional policy.
- For designated protocols, assist the PI and/or protocol team with protocol development, revision, and study analysis.
- Provide leadership and guidance to program/research assistants in the execution of their duties relative to protocol implementation.
- Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.

Additional Duties May Include:
- Completing physical exams (including pelvic exams)
- Performing clinical procedures necessary to obtain various mucosal specimens including performing skin biopsies, rectal biopsies, vaginal biopsies, and cervical biopsies.

Required:
- RN or ARNP
- Strong written and verbal communication skills including computer skills, proficiency with MS Word, Excel, and PowerPoint are essential

Preferred:
- A minimum of two years of clinical research is strongly preferred
- Previous experience in clinical data collection is preferred
- Knowledge of Spanish helpful

*This position will require some weekend and evening hours.*

We are a VEVRAA Federal Contractor.

If interested, please apply online at http://track.tmpservice.com/ApplyClick.aspx?id=2330558-2647-8421

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