The Department of Medicine, Internal Medicine seeks an APP/Operations Manager (Sr. Nurse Practitioner) for the HIV Clinical Outcomes Program. The program's core team consists includes the principal investigator, 5-6 lead investigators, three data managers/data analysts, four research data abstractors, two study coordinators, two research assistants and the APP/Operations Manager (APP/OM). The APP/OM assumes the responsibility for the coordination, supervision and strategic implementation of the clinical research performed within the HIV Outcomes Program.
The APP/OM directs all research procedures, manages study staff and is responsible for the overall coordination and management of administrative, operational processes for the Johns Hopkins HIV clinical cohort and three collaborative projects. This individual, along with the Principal Investigator (PI) will serve on Executive and Steering Committees as part of collaborative initiatives to ensure that the program meets its research objectives. The APP/OM leads research and program efforts locally, specifically to promote systems improvement in data capture, data storage and assurance of data quality.
This position implements the strategic direction of the HIV Outcomes Research Program through technical expertise, program oversight, and budgetary monitoring. The APP/ OM works with the PI and investigators to plan for the execution of studies and delivery of research files within the program itself and as part of the external collaborative research projects undertaken by the Outcomes Program. There are three large, collaborative research initiatives within the HIV Outcomes program that require separate processes for data processing, quality review and cleaning, data submission and creation of data files for analytical use. Research priorities can and will evolve over time with new collaborations developing; it is the responsibility of the APP/OM to lead the process of reconfiguring internal procedures for data collection to meet program requirements and research aims.
Study related processes include:
Johns Hopkins HIV Clinical Cohort (JHHCC): a large, longitudinal clinical cohort that is federally funded since 1989 with complex data collection activities that require periodic examination and revisions in data capture and processing based on increased availability of electronic clinical data. The data collection activities for this cohort provide the central core elements for the subsequent three major collaborative projects.
CFAR Network of Integrated Clinical Systems (CNICS): Federally funded in 2006 to support HIV clinical outcomes research, we are one of nine sites that submit clinical and resource utilization data to a central coordinating center at specified intervals. Data submissions follow a standardized protocol and are significantly different from those of the HIV Cohort. Direction and oversight is required to transform HIV clinical cohort data into the required format for CNICS processing.
North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD): Federally funded in 2006, this group 25 collaborating cohorts is designed to be representative of HIV Care in the US and Canada with the goal of answering questions of regional and interregional importance specific to clinical issues in the current treatment era.
The Collaborating Consortium of Cohorts Productizing NIDA Opportunities (C3PNO): A federally funded group of 9 cohorts studying the intersection of HIV infection and substance abuse. The HIV Outcomes Program submits data from JHHCC semi-annually to the data coordinating center using a standardized protocol.
The APP/OM will represent and interface with leadership from the other collaborating institutions to provide input on the local process, ensure that what may be of scientific interest can be achieved with the data collected locally. The position requires excellence in problem-solving, oral and written communication skills, knowledge of programming languages, computer processing environments and programming experience in health-based data to develop and maintain research and clinical-based files that relate to the care and treatment of HIV. A clinical licensure is required to sign clinical research orders; there is a possibility that as new studies are implemented, this individual will conduct clinical research visits.
This individual will supervise and organize the activities of the three data analysts, hire, and train and supervise the senior staff of the program, and provide the clinical expertise and oversight that is required to successfully execute data abstraction of clinical records, consent, and conduct participant interviews. Successful execution of local research efforts are dependent upon the APP/OM working collaboratively with the clinical leadership in the John G. Bartlett Specialty practice, the central site of recruitment for the JHHCC.
There is the expectation that this individual has programming skills and good understanding of the database management tools to create, import, convert, and restructure files by writing code and reconfiguring data to conform to the needs of all four projects. The current database structure uses Microsoft SQL server for data storage.
This individual is responsible for data submissions related to the CNICS, NA-ACCORD and C3PNO.
ESSENTIAL JOB FUNCTIONS:
Develop budgets and staffing requirements, in conjunction with the PI, to ensure that staffing is appropriate of all aspects of the program.
Train and supervise senior staff.
Develop and implement systems for monitoring, reporting, and quality assurance activities.
Ensure program quality, research fidelity, and adherence to project goals and timelines.
Provide guidance and training on existing data storage systems and data assurance activities.
Conduct record reviews for selected sub-studies. Train and supervise contractual personnel to conduct record reviews.
Submit data requests through the Center for Clinical Data Analysis (CCDA) to support study aims.
Construct data files for submission data coordinating centers as needed.
Recommend procedures for database maintenance and database enhancements for three programmers/analysts to execute.
Define system scope and objective based on user-defined needs. Solve complex problems in regards to desired results.
Apply system analysis techniques and procedures to gather and translate complex research requirements into functional/technical specifications and design and perform subsequent quality assurance tasks.
Develop documentation detailing all database structures, movement and processes.
Provide selected statistical analysis programming (description, univariate, and multivariate) in cooperation with study investigators.
Maintain study policies, standards, practices, and security measures to ensure effective and consistent information processing operations and to safeguard information resources.
Sign research orders for the project(s).
Additional Knowledge, Skills and Abilities:
Proficiency in Microsoft Office.
Knowledge of basic skills using SQL and statistical software such as SAS and STATA.
Proficiency in use of Epic.
Formal training in epidemiologic and bio statistical methods for clinical research.
Experience with analysis/management of health-based data.
Proficiency in writing technical and programmatic reports as well as manuscripts for peer-reviewed scientific journals.
Ability to manage multiple projects simultaneously.
Extensive knowledge of clinical research on manifestations of HIV disease and related illnesses
Interaction with program staff is frequent and the ability to work well as a member of a health care team with a high degree of self-motivation is required.
Professional interaction with interagency programming staff as well as research staff and faculty this program collaborates with is necessary.
Completion and competency of University modules for the conduct of Clinical Research.
Ability to work independently.
Ability to meet deadlines.
Master's degree in nursing; Registered Nurse license and Certified as a Nurse Practitioner. Must be licensed as NP in State of Maryland or other state where practicing. Requires minimum of 3 years' experience in related clinical area, and obtained proficiency in area of specialty. Residency or fellowship programs in area of specialization may substitute for some experience. Current CPR certification required. Must maintain current licensure and certification during duration of employment. Completion of the JHH credentialing process is required prior to start date.
Minimum of 5 years' experience in health care setting required.
Master's degree in public health, epidemiology, or other health-related field with experience in computing, epidemiology or biostatistics is also desirable.
Experience should include the following: personnel supervision, health sciences research, data management, analysis, grant reporting and research writing.
This position requires an individual with clinical licensure to allow for ordering of research laboratory studies and more detailed record review using Epic, which is not possible without a clinician designation in Epic.
Sitting, standing and walking for extended period. Reaching by extending hand(s) or arm(s) in any direction. Finger dexterity required to manipulate objects with fingers rather than with whole hand(s) or arm(s). Ability to move standard equipment through a hospital or clinical environment.
Classified Title: Sr. Nurse Practitioner Working Title: Sr. Research NP Role/Level/Range: ACRP/04/MG Starting Salary Range: Competitive; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 8:30am - 5:00pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department Name: Medicine, General Internal Medicine Personnel Area: School of Medicine
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