We are seeking a Sr. Research Nurse who will be responsible for the implementation and conduct of clinical trials for the NIH-funded Clinical Research Site (CRS, Positive Choices Research Unit) and HIV Prevention Trials Network (HPTN) with oversight and accountability for the delivery and overall performance of assigned studies as the study lead. This position is based at the Johns Hopkins Medical Institutions. Responsibilities will include recruiting, enrolling and following participants, including healthy non-HIV infected participants, healthy asymptomatic HIV-infected individuals and those with end-stage AIDS. In addition to HIV-related clinical research, research of other infectious diseases may be conducted as well. The position will also involve participation in the ACTG and HPTN at a national level through involvement on protocol teams and/or ACTG/HPTN committees, as well as a role in the community providing HIV-related education. This position will work closely with the Site Manager.
General Duties & Responsibilities
General Research Aspects
- Recruit, screen and enroll eligible participants into clinical protocols.
- Explain the protocol in detail and obtain informed consent from potential participants in accordance with the Joint Committee on Clinical Investigation which operates in compliance with the U.S. Code of Federal Regulations, Department of Health and Human Services Title 45 Part 46 as well as the Food and Drug Administration (FDA) regulations and good clinical practice standards.
- Collect necessary data through participant interviews including, but not limited to, past medical history, present illness, social history, family history, medication history.
- Coordinate and document all aspects of participant care to ensure a comprehensive and consistent approach to the participants treatment.
- Complete source documents from visits accurately and completely for data entry to the database.
- Coordinate laboratory specimen processing and handling with appropriate lab supervisors.
- Participate in local quality management procedures of data through daily interactions with the data management team.
- Maintain confidential records of participants according to FDA and NIH regulations.
- Assist in maintenance of statistics of participant status.
General Nursing Aspects
- Perform phlebotomy, vital signs, throat cultures, and other procedures within the scope of the Nurse Practice Act as needed, and as directed by specific protocols.
- Initiate laboratory tests as defined within the scope of the protocols.
- Manage laboratory abnormalities and adverse experiences as directed by the protocols, and when appropriate, notify the primary care provider, as well as both the Principal Investigator and Site Manager of the research unit immediately.
- Perform physical assessments of study participants as needed during visits, with appropriate triage and referral to primary medical providers and/or subspecialty care providers.
- Monitor the ACTU 24-hour beeper used for panic results from labs as well as for participants with questions on a rotating basis with other licensed clinical staff.
- Complete in a timely fashion and provide to the office of nursing accreditation and the unit manager the required documentation for continued nursing licensure accreditation and annual reviews required for practice within the organization.
Protocol Team Leader
- Manage the overall implementation and conduct of clinical research protocols by coordinating and supervising each phase of the research process.
- Assist with obtaining Institutional Review Board (IRB) and General Clinical Research Center (GCRC) approval of protocols by developing and submitting the protocol synopsis and written informed consent document, reports, summaries and other required materials.
- Orient other key staff to protocols by organizing and coordinating training sessions.
- Ensure adequacy of supplies needed for specific protocols.
- Act as resource for back-up staff assisting with protocol.
- Develop recruitment strategy including outreach fliers and posters.
- Represent protocol at staff meetings, community meetings, service meetings, etc. as assigned.
- Assist data management team with resolution of data inconsistencies.
- Maintain protocol statistics, including participant status, recruitment logs and enrollment logs.
Expanded Research Aspects
- Contribute to the protocol development process as the Field Representative on protocol teams.
- Represent the Johns Hopkins Adult ACTU as a leader and/or member on national committees within the ACTG.
- Conduct special independent research projects as the opportunity arises.
Education Aspects
- Present information relevant to HIV and/or clinical trials to healthcare facilities, community groups, schools, etc.
- Participate on boards and committees of organizations relevant to HIV.
Minimum Qualifications
- Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline required. Master's degree strongly preferred.
- Minimum of two years experience in the specialty or a related area required.
- Additional experience may substitute for bachelor's degree and related master's degree may be considered in lieu of experience.
Preferred Qualifications
- Understanding of epidemiologic and clinical aspects of HIV infection and sensitivity to the psychological, social and medical needs of persons infected with HIV.
- Knowledge of clinical epidemiology, study design, data analysis and ability to maintain meticulous study records.
- Familiarity with clinical drug trials.
- Familiarity with clinical resources, laboratory facilities and community organizations with an HIV focus.
Classified Title: Sr. Research Nurse
Role/Level/Range: ACRP/04/MF
Starting Salary Range: $75,100 - $131,700 Annually ($100,000 targeted; Commensurate with experience)
Employee group: Full Time
Schedule: Monday-Friday, 8:30am-5:00pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM DOM ID ACTG
Personnel area: School of Medicine
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