Sr. Research PA

The Department of Medicine, Internal Medicine seeks an APP/Operations Manager (Sr. Physician Assistant) 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 HIV Clinical Outcomes Program consists of a core team, which 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:

1. 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.
2. 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.
3. 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.
4. 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, 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:

1. Develop budgets and staffing requirements, in conjunction with the PI, to ensure that staffing is appropriate of all aspects of the program.
2. Train and supervise senior staff.
3. Develop and implement systems for monitoring, reporting, and quality assurance activities.
4. Ensure program quality, research fidelity, and adherence to project goals and timelines.
5. Provide guidance and training on existing data storage systems and data assurance activities.
6. Conduct record reviews for selected sub-studies. Train and supervise contractual personnel to conduct record reviews.
7. Submit data requests through the Center for Clinical Data Analysis (CCDA) to support study aims.
8. Construct data files for submission data coordinating centers as needed.
9. Recommend procedures for database maintenance and database enhancements for three programmers/analysts to execute.
10. Define system scope and objective based on user-defined needs. Solve complex problems in regards to desired results.
11. 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.
12. Develop documentation detailing all database structures, movement and processes.
13. Provide selected statistical analysis programming (description, univariate, and multivariate) in cooperation with study investigators.
14. Maintain study policies, standards, practices, and security measures to ensure effective and consistent information processing operations and to safeguard information resources.
15. Sign research orders for the project(s).

SUPERVISES: 10-12 In-house staff members and personnel hired for special projects.

QUALIFICATIONS:

Technical Skills:

1. Proficiency in Microsoft Office
2. Knowledge of basic skills using SQL and statistical software such as SAS and STATA
3. Proficiency in use of Epic
4. Formal training in epidemiologic and bio statistical methods for clinical research
5. Experience with analysis/management of health-based data
6. Proficiency in writing technical and programmatic reports as well as manuscripts for peer-reviewed scientific journals
7. Understanding of statistics
8. Decision making/trouble shooting abilities required
9. Demonstrated self-management (i.e. motivation, time-management, adaptability)
10. Ability to manage multiple projects simultaneously

Knowledge:

1. Extensive knowledge of clinical research on manifestations of HIV disease and related illnesses

EDUCATION AND EXPERIENCE

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. A clinical degree an advanced practice practitioner (APP), and a minimum of three years of related clinical experience. Master’s degree in public health, epidemiology, or other health-related field with experience in computing, epidemiology or biostatistics is also desirable. Minimum of 2 years’ experience in health care setting required. Experience should include the following: personnel supervision, health sciences research, data management, analysis, grant reporting and research writing.

LICENSURE, CERTIFICATION, REGISTRATION: Licensure in the State of Maryland as a Physician Assistant by the Maryland Board of Physicians, and certification as Physician Assistant is required.

Minimum Knowledge, Skills and Abilities Required

1. 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.
2. Professional interaction with interagency programming staff as well as research staff and faculty this program collaborates with is necessary.
3. Completion and competency of University modules for the conduct of Clinical Research
4. Ability to work independently
5. Ability to meet deadlines

Classified Title:Sr. Physician Assistant
Working Title: Sr. Research PA
Role/Level/Range: ACRP/04/MG
Starting Salary Range:commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30-5:00
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10002809-SOM DOM General Internal Medicine
Personnel area: School of Medicine

The successful candidate(s) for this position will be subject to a pre-employment background check.

If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office atjhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711.

The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.

During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.

The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.

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