A Research Program Manager is needed to provide program development and leadership over the Infectious Diseases and Substance Use Center at Johns Hopkins Bayview Medical Center. The research program manager manages and trains research program coordinators and research assistants and partners with the Research Support Associate to guide pre-award and post-award grant activities. The successful candidate will be able to develop and implement interventional and observational studies within clinical and community settings at and around Johns Hopkins Hospital and Johns Hopkins Bayview Medical Center, with the ability to “zoom in” to matters of regulatory compliance and operations and “zoom out” to matters of broader programmatic leadership and problem-solving.
Specific Duties and Responsibilities:
Leads the scientific implementation and daily operation of research studies, monitoring protocol compliance.
Provides direct supervisory support of research staff members.
Develops research protocols and associated procedures to achieve specific research aims.
Oversees the coordination of all activities of a research study to assure validity of findings. Provides direct assistance with study coordination when needed to cover for absent staff.
Ensures adherence to the protocol and oversees record management for the research studies.
Assists with budget development and award preparation and submissions.
Develops tools for study implementation including data collection tools such as REDCap, standardized order sheets, study reference materials, and patient questionnaires. Evaluates these tools on an ongoing basis for validity.
Prepares and submits all study related updates, changes to research, required reports and study related instruments to IRB.
Maintains regular communication with IRB to ensure efficient review of study documents throughout the life span of each protocol.
Organizes the flow of study participants in the clinic; ensures compliance with study visits and medications through frequent contact with study participants.
Develops data collection instruments and other study specific tools necessary for conduct of the study per protocol.
Abstracts medical data from charts requiring interpretation.
Performs quality assurance/quality control on data collected at study visits including review of source documents.
Act as a liaison for the study with the health care team, other institutions, patients and their primary care provider.
Initiates communication, develops relationships and establishes processes with institutional resources necessary for study related procedures including surgical pathology, reference histology, gastroenterology, endoscopy, Moore Clinic phlebotomy, the Rangos laboratory, the ICTR and the Specialty Clinic at Blalock.
Maintains regulatory files for the study in compliance with Sponsor/FDA/NIH/IRB guidelines.
Assists outside monitors during study audits. In addition, this individual will assist with quality assurance and regulatory procedures including communications with the IRB, FDA, NCCAM, and DSMB.
Participates in study meetings and provides updates on protocol implementation status and makes recommendations on operational issues.
Maintains regular communication with the central coordination site for multi-site studies.
Oversees and tracks budget expenditures for the study operation.
Performs backup research pharmacist duties.
Trains research assistants and students in clinical research activities.
Manages the petty cash account and subject remuneration process.
Maintains organized freezer storage process and specimen tracking.
Oversees all study recruitment procedures consistent with IRB approved methods.
Handles and oversees specimen processing and shipments.
Assists other study team members with research related activities on other projects as needed
Minimum Qualifications (mandatory):
Bachelor’s degree in related discipline required.
Minimum of 5 years related.
Demonstrated supervisory or lead responsibilities required.
Additional education may substitute for the required experience, to the extent permitted by the JHU Equivalency Formula***.
Demonstrated supervisory or lead responsibilities required.
Experience working with human subjects required.
Related Master’s degree preferred.
Special Knowledge, Skills, and Abilities:
Experience in health science research, data management and analysis.
Experience in grant reporting and research writing.
Excellent communication skills necessary along with demonstrated self-management.
Sound decision making skills and excellent problem solving skills required.
Must be autonomous, with a high level of independence
Must be able to interact effectively with study participants from diverse backgrounds. Certified Clinical Research Coordinator (CCRC) preferred.
Experience in public/community health
***JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 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.
Classified Title: Research Program Manager Working Title: Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495-$72,210 (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: 10002794-SOM DOM Bay Infectious Disease 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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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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