As part of a study team, the Sr. Research Nurse will oversee study-related activities for multiple studies for the NIH-funded AIDS Clinical Trials Unit (ACTU); Practice nursing per study protocol(s) and under the nursing scope of practice for the State of Maryland. The study protocols are designed to include both outpatients and inpatients ranging from healthy asymptomatic HIV-infected individuals to those with end-stage AIDS. The position will also involve participation in the ACTG at a national level through involvement on protocol teams and/or ACTG committees, as well as a role in the community providing HIV-related education. This position will work closely with the Research Program Manager and must be able to stand in as the liaison/representative when the Research Program Manager is not present.
The Sr. Research Nurse will also evaluate vital sign data. Complete the clinical case report forms, submit to the coordinating center, and respond to queries in the required time frame established by the study protocol. Investigate adverse events and report to the principal investigator timely. Assist with administrative duties relating to research trial including submission of IRB protocols, recruitment, and informed consent.
Specific duties & responsibilities:
General Clinical Aspects
Obtain and/or review vital signs, update patient medical histories for physician review, and perform other procedures as directed by specific protocols.
Schedule and report laboratory tests as defined within the scope of the protocols.
Record laboratory abnormalities and adverse experiences as directed by the protocols, and when appropriate, notify the principal investigator of the study, the Research Program Manager, and the primary care provider immediately.
Determine the need for the principal investigators to perform protocol specified physical exams and targeted physical assessments of patients during study visits, with appropriate triage and referral to primary medical providers and/or subspecialty care providers as directed.
Maintain protocol specific templated notes on each research subject in an assigned protocol
Monitor the ACTU 24 hour beeper used for panic results from labs as well as for patients with questions on a rotating basis with other licensed clinical staff.
Other duties as assigned.
General Research Aspects
Recruit, screen and enroll eligible patients into clinical protocols.
Explain the protocol in detail and obtain informed consent from potential patients 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.
Collect necessary data through patient interviews including, but not limited to, past medical history, present illness, social history, family history, medication history.
Coordinate and document all aspects of patient care (including telephone contact with patient, or friends/family of the patient; conversations with the research team and all medical providers who participate in the patients care, etc.) to ensure a comprehensive and consistent approach to the patients treatment.
Transcribe data completely and accurately to the case report forms for data entry to the database.
Maintains confidential records of required source documentation on each assigned research protocol.
Coordinate laboratory specimen processing and handling with appropriate lab supervisors.
Participate in local quality control 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 patient status.
Other duties as assigned.
Protocol Team Leader
Manage the implementation and conduct of clinical research protocols; Coordinate and supervise each phase of the research process.
Obtains 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.
Implement protocols as assigned by becoming familiar with all aspects of their conduct.
Orient other key staff to protocols by organizing and coordinating training sessions.
Ensure adequacy of supplies needed for specific protocols.
Act as a resource to staff who are assisting with clinical research protocols (i.e. the Research Assistant and Administrative Secretary)
Develop recruitment strategy including outreach fliers with the outreach worker.
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 patient status, recruitment logs and enrollment logs.
Other duties as assigned.
Expanded Research Aspects
Represent the Johns Hopkins Adult ACTU as a leader and/or member on national committees within the ACTG.
Attend Adult AIDS Clinical Trials Group meetings
Other duties as assigned.
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 (e.g. Ryan White Title I Healthcare Subcommittee, Maryland Chapter Hemophilia Foundation).
Other duties as assigned.
Individual must be a registered nurse, licensed in the State of Maryland or state where practicing. Bachelor's degree in nursing or related discipline preferred. Current CPR certification required. Must maintain current licensure and certification during duration of employment. Acceptable completion of the JHH credentialing process is required prior to start date.
Two years’ experience in clinical trials and/or clinical research in a patient setting required.
Requires understanding of epidemiologic and clinical aspects of HIV infection and sensitivity to the psychological, social and medical needs of persons infected with HIV.
Requires familiarity with clinical resources, laboratory facilities and community organizations with an AIDS focus.
Interpersonal skills to collaborate effectively with Principal Investigator, other staff members and research participants.
Experience in clinical research
Knowledge of clinical epidemiology, study design and data analysis required.
Familiarity with clinical drug trials
Strong organizational and communication skills essential.
Ability to maintain meticulous study records
A high degree of self motivation and the ability to function independently.
PC Skills: Microsoft Word, Excel, PowerPoint and Access. Internet Browsers and PDF
Classified Title: Sr. Research Nurse Working Title: Sr. Research Nurse Role/Level/Range: ACRP/04/MF Starting Salary Range: $70,805 – 97,435 Employee group: Full Time Schedule: M-F 8:30-5 Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 60000501-SOM DOM ID ACTG Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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