Clinical Research Program Specialist

General Description:

The Clinical Research Program Specialist will work with a team of researchers coordinated by Dr. Marilyn Albert, Professor of Neurology at the Johns Hopkins School of Medicine. The Clinical Research Program Specialist will have administrative responsibilities pertaining to two inter-related research programs related to Alzheimer’s disease (AD) at the Johns Hopkins School of Medicine.

Research Programs:

The position will involve administrative responsibilities for:  (1) the Johns Hopkins Alzheimer’s Disease Research Center (JHADRC) and (2) the BIOCARD Study, which are supported by funds from the National Institute on Aging. Both of these programs involve senior and junior investigators from many disciplines across Johns Hopkins University (JHU). The JHADRC has been funded for over 30 years and provides infrastructure support, research funding and training to investigators at JHU, in order to promote and facilitate research in AD and related disorders at the institution. The JHADRC oversees these activities through a series of Cores, which include: (1) an Administrative Core that oversees the strategic planning and operation of the Center as a whole; (2) a Clinical Core that conducts annual clinical and cognitive evaluations of the Center participants, both with and without cognitive impairments; (3) a Biomarker Core that collects blood and cerebrospinal fluid specimens and brain images on the participants, and is responsible for analyzing and distributing data and specimens; (4) a Neuropathology Core that evaluates brain tissue from participants who come to autopsy; (5) an Outreach, Recruitment and Engagement Core that provides education about Alzheimer’s disease and related disorders in the community and assists in subject recruitment and retention; (6) a Research Education Component that provides training to junior investigators and organizes a seminar series and annual day-long meeting for the JHU research community; and (7) a Biostatistics Core that provides bio statistical support and data files to investigators, and oversees the database that tracks the activities of the JHADRC Cores that are essential to the smooth functioning of the Center. The BIOCARD Study has been funded for over 10 years and is a longitudinal study focused on the earliest phases of Alzheimer’s disease. The study is composed of 7 Cores and 2 Projects. The Cores are comparable to those in the JHADRC and include: (1) an Administrative Core that oversees strategic planning and integration of the Cores and Projects; (2) a Clinical Core that conducts annual clinical and cognitive evaluation on participants, with and without cognitive impairments, as well as subject recruitment and retention; (3) an Imaging Core that acquires magnetic resonance imaging (MRI) scans and positron emission tomography (PET) scans from the participants and is responsible for  analyzing the scans and distributing data and scans to investigators; (4) a Bio specimen Core that acquires blood and cerebrospinal fluid specimens from the participants and is responsible for analyzing the specimens and distributing them to investigators, as appropriate; (5) an Informatics Core that oversees data entry, data quality, data distribution and management of the project website; (6) a Neuropathology Core that oversees the evaluation of brain tissue from participants who come to autopsy; and (7) a Biostatistics Core that is responsible for analyzing data collected through the Cores and Projects. Two research projects are also included in this program, as noted above.  

The day-to-day responsibilities of the Clinical Research Program Specialist include:

• Assists in the development and implementation of a comprehensive strategy for the research, training and educational activities of these programs, to include organizational oversight and governance activities.
• Works closely with the director and the clinical and basic science team members to assure effective implementation of program initiatives. Develops and implements working structures to coordinate program efforts, and ensure milestones are achieved.
• Coordinates meeting logistics, including assistance with scheduling, drafting of agendas, preparation and dissemination of meeting minutes and tracking action items.
• Works closely with program leadership to establish funding priorities and track expenditures over time. Assists the financial manager in the preparation of budgets.
• Helps to coordinate the preparation of research agreements, including contracts, data use agreements, and material transfer agreements.
• Assists the leadership in assuring that all regulatory requirements are met, including biosafety regulations, reports to the IRB/IACUC, and provision of regulatory documents to funding agencies, as needed.
• Assists in the development and implementation of communication plans and website content.
• Assists the leadership in evaluating the success of the research programs, and developing recommendations for program growth.  Helps identify strategies and practices to help the research programs operate more efficiently in order to achieve the short- and long-term goals of the programs.
• Assists in the development of additional sources of funding and communications with donors. 
• Assists with interactions between academic and industry partners, as needed. 
• Assists in the preparation of progress reports that summarize operational progress, challenges and alternative strategies across the clinical, basic science and financial arms of the program, as needed. Ensures that progress reports are submitted to the leadership team, funding agencies, the leadership of the School of Medicine, the donors, and the lay community, as appropriate.
• Travels to conferences, to meetings with external collaborators and key donors, as required.
• Performs other related duties as necessary.

Qualifications:

Requires a bachelor’s degree, preferably in health-related sciences. Masters in relevant field preferred.

Requires minimum of five years of experience in clinical research at an academic, government, or pharmaceutical industry environment, and experience in clinical research and regulatory affairs. 

Education may substitute for some experience, to the extent permitted by the JHU equivalency formula.

JHU Equivalency Formula:

18 graduate degree credits may substitute for one year of experience.    

For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job. 

Requires good organizational skills, good interpersonal skills, familiarity with basic medical terminology, and the ability to work with a team of junior and senior researchers across many disciplines. Must have good computer skills, and the ability to provide administrative support to many ongoing activities at the same time.  Must be able to work independently with modest direction. 

Classified Title: Clinical Research Program Specialist 
Working Title: Clinical Research Program Specialist  ​​​​​
Role/Level/Range: ACRP/04/MC 
Starting Salary Range: $45,195-$62,225 (commensurate with experience)
Employee group: Full Time 
Schedule: M-F 8:30 am - 5:00 pm 
Exempt Status: Exempt  
Location: 04-MD:School of Medicine Campus 
Department name: 10003516-SOM Neuro Cognitive Neurology 
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 at jhurecruitment@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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