Overview

Fred Hutchinson Cancer Center is an independent, nonprofit, unified adult cancer care and research center that is clinically integrated with UW Medicine, a world leader in clinical care, research and learning. The first National Cancer Institute-designated cancer center in the Pacific Northwest, Fred Hutch's global leadership in bone marrow transplantation, HIV/AIDS prevention, immunotherapy, and COVID-19 vaccines has confirmed our reputation as one of the world's leading cancer, infectious disease and biomedical research centers. Based in Seattle, Fred Hutch operates eight clinical care sites that provide medical oncology, infusion, radiation, proton therapy, and related services, and network affiliations with hospitals in five states. Together, our fully integrated research and clinical care teams seek to discover new cures to the world's deadliest diseases and make life beyond cancer a reality.

The Seattle Vaccine Trials Unit (VTU) is a program of the Vaccine & Infectious Disease Division of the Fred Hutchinson Cancer Center. In existence since 1987, the VTU has conducted an array of studies researching the immunology and prevention of HIV, malaria, and COVID. Led by Principal Investigator Julie McElrath, the VTU conducts clinical trials and observational studies. The VTU's main clinical trials clinic is located on First Hill. The COVID Cohort observational study is based at the main campus of Fred Hutch on South Lake Union.

At Fred Hutch, we believe that the innovation, collaboration, and rigor that result from diversity and inclusion are critical to our mission of eliminating cancer and related diseases. We seek employees who bring different and innovative ways of seeing the world and solving problems. Fred Hutch is in pursuit of becoming an antiracist organization. We are committed to ensuring that all candidates hired share our commitment to diversity, antiracism, and inclusion.

The Clinical Research Nurse/Nurse Practitioner implements and conducts clinical research studies involving human participants for the Vaccine Trials Unit research program. The primary location and focus for this position (either First Hill/clinical trials or main campus/observational studies) will be determined during the hiring process as an applicant's specific background is assessed in the context of the work occurring in each of these locations. In both locations, the role consists of screening, enrolling, and following clinical research participants through study visits. The COVID Cohort observational study involves enrolling individuals with active COVID, and follow-up of these individuals as well as others who have recovered. The clinical trials primarily involve enrolling healthy volunteers to receive HIV prevention interventions (vaccines, immunoprophylaxis, etc) in Phase 1, 2, and 3 trials.

The incumbent works under the overall supervision of the Principal Investigator and direct/on-site supervision by the COVID Cohort Lead Nurse Practitioner or VTU Medical Director. The work will be conducted 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. All staff members are required to follow regulatory and GCP guidelines and institutional policies.

Responsibilities

Major duties/COVID Cohort:

• By phone call, explain the scientific rationale, eligibility criteria, and protocol procedures for the COVID Cohort study, determine participant eligibility, and obtain electronic informed consent.
• Conduct in-person enrollment and follow-up study visits at the Minor building (at Fred Hutch main campus, on South Lake Union). Study visits include collecting data from participants about their COVID illness and providing clinical, scientific, and protocol-specific updates as relevant.
• Coordinate with other staff members to prepare blood and nasal samples for clinical and research labs, and other communication with the research lab.
• Other work may include communicating with participants by phone, text, or email, to address questions regarding COVID exposures and/or symptoms and provide guidance for accessing on-study testing or clinical care.
• Data clarification as needed, in coordination with the overall study team (PI, lead clinician, data team).
• Occasionally conduct participant visits at off-campus locations. The locations are based on existing collaborations with first responders, and have included study conduct at remote locations including fire stations in Everett. Additional remote locations may be involved as scientific priorities evolve with the ongoing study of SARS-CoV-2.

Major duties/Clinical Trials:

• Determine participant study eligibility, obtain informed consent, and initiate participant enrollment in research studies in accordance with regulatory and GCP guidelines and institutional policy including:
  • Provide a complete explanation of a study to potential volunteers to obtain informed consent.
  • Record and evaluate medical histories as well as social and sexual histories.
  • Draw blood for screening labs if required per protocol, and interpret the results for inclusion/exclusion criteria, as well as for medical follow-up if needed.
  • Provide pregnancy prevention counseling, including contraceptive counseling as needed.
  • Conduct physical exam assessments per protocol requirements.
• Follow study protocol for each participant visit.
• Perform clinical procedures including vital signs, vaccine administration, blood draws, IV infusions, and physical exam assessments.
• For specific protocols: Collect mucosal secretions and other samples, potentially including rectal secretions, saliva, nasal secretions.
• For ARNP applicants: For specified protocols, conduct rectal/pelvic exams and obtain mucosal biopsies (vaginal, cervical, rectal).
• Accompany participants to protocol-specific procedures (e.g. ultrasound-guided lymph node sampling) in order to provide research oversight and context to the clinical procedure.
• Maintain appropriate source documentation and complete case report forms/electronic case report forms.
• Identify, assess, and report adverse events in accordance with protocol and regulatory guidelines and institutional policy.
• Provide relevant health education to study participants and provide appropriate referrals to community medical, social, substance abuse and mental health programs if needed.
• Help to maintain the compliance of participants with protocol visit schedule.
• Provide support for community education and recruitment with the VTU community educator, recruitment coordinator, and outreach team.
• Assist the study coordinators in managing the daily operations of a research study.
• Assist the study coordinators in developing tools for study implementation including data collection tools and study reference materials.
• Provide leadership and guidance to program/research/clinical assistants in the execution of their duties relative to protocol implementation and conduct.
• Maintain thorough knowledge in the field through attending related project meetings and symposia, reading related literature, and maintaining professional associations.

For both positions, the clinician will maintain certification for clinical responsibilities, GCP, Human Subjects Research, and protocol-specific trainings.

Qualifications

• Current WA state RN or ARNP license.
• A minimum of two years of clinical research is strongly preferred, including previous experience in clinical data collection and electronic data capture.
• Strong desire to work with people with diverse backgrounds.
• Ability to foster an inclusive environment for clinical research participation.
• Strong written and verbal communication skills and computer skills.

Fred Hutch has a mandatory COVID-19 vaccine requirement, with exceptions only for approved medical or religious accommodations.As a condition of employment, newly hired employees must provide proof of vaccination or initiate the accommodations process before their first day of employment.

A statement describing your commitment and contributions toward greater diversity, equity, inclusion, and antiracism in your career or that will be made through your work at Fred Hutch is requested of all finalists.

Our Commitment to Diversity

We are proud to be an Equal Employment Opportunity (EEO) and Vietnam Era Veterans Readjustment Assistance Act (VEVRAA) Employer. We are committed to cultivating a workplace in which diverse perspectives and experiences are welcomed and respected. We do not discriminate on the basis of race, color, religion, creed, ancestry, national origin, sex, age, disability (physical or mental), marital or veteran status, genetic information, sexual orientation, gender identity, political ideology, or membership in any other legally protected class. We are an Affirmative Action employer. We encourage individuals with diverse backgrounds to apply and desire priority referrals of protected veterans. If due to a disability you need assistance/and or a reasonable accommodation during the application or recruiting process, please send a request to our Employee Services Center at hrops@fredhutch.org or by calling 206-667-4700.