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Johns Hopkins University Research Program Manager in Baltimore, Maryland

The Johns Hopkins School of Medicine seeks an experienced Research Program Manager to work closely with Department of Pediatrics Vice-Chairs for Research and the Assistant Administrator for Research in activities relating to mentoring new research staff in fulfillment of job duties and supporting faculty in clinical research efforts. These activities will facilitate: (i) the efficient completion of funded research; (ii) the initiation of industry-initiated trials which will generate revenue for the Department while promoting the academic productivity of faculty; (iii) the completion of study-related tasks for unfunded faculty in pursuit of pilot data for grant applications; (iv) completion of data collection for faculty between grants which will allow for continued productivity and successful future grant applications.

Under limited supervision, this position will support departmental research programs and/or clinical trials by providing needed expertise for the coordination of investigator and industry-initiated protocol implementation from start to finish. The range of duties includes, but is not limited to: IRB application; Manual of Procedure development; study staff training; database development and management; participant recruitment and enrollment; study visit procedures including interviews/survey implementation, specimen collection, measure coordination; data collection; expenditure oversight; and communicating with team members on the status of project(s). This individual will be a resource for all Department research staff and will assist in the recruitment of new hires. They will also supervise and evaluate the performance of Department research assistants and coordinators, and will provide needed feedback and (re)training.

Specific Duties & Responsibilities:

  • Assist investigators in development and implementation of clinical research protocols. This may include: Developing and managing study timeline and program management plan;

  • Coordinate interactions of clinical research programs across the divisions of the department of Pediatrics to facilitate collaborative efforts and activities.

  • Study coordination, including hiring and supervision of graduate students and research assistants/coordinators; assisting investigators with recruitment protocols that are practical and efficient.

  • Coordinate training of study teams on eIRB and CRMS systems.

  • Preparation and submission of protocols for submission to the JH School of Medicine Institutional Review Board (or similar IRB) including the management of ongoing submissions (i.e. change in research requests, continuing review reports, adverse events, significant adverse events). Stay informed of IRB protocol changes and general updates. Troubleshoot IRB communications problems. Keep track of all study approval dates and timelines for required communication to IRB.

  • Provide research administration support for industry sponsored trials.

  • Prepare dissemination materials (ppts, documents, reports) for relevant agencies (e.g. funders, IRB, scientific team, key stakeholders, community advisory board/s) and other forums for dissemination of interim or final study results.

  • Abstract data from patient medical records that requires some interpretation. Monitors data quality and accuracy as required by research protocol. Will run pre-established queries and may develop ad-hoc queries/reports as requested Utilizing working knowledge of study(s) will participate in meetings to provide operational updates, report on any operational issues, and may make recommendations for resolutions to new/outstanding operational issues. May assist in coordinating study(s) meetings, which may include assisting in developing an agenda and coordinating information and/or participation of individuals from other institutions and/or universities.

  • Initiate and/or maintain activities, systems and processes to increase referrals and increase accruals to multiple clinical trials.

  • Assist with tracking and reporting milestones for financial invoicing.

  • Where helpful, take study meeting minutes and develop and track action steps.

  • Inform faculty and research staff of Hopkins resources to help facilitate study completion, grant submission, manuscript preparation (including referral to BEAD Core, SCAMP, Welch Informationist as examples).

  • Other duties as assigned.

Minimum Qualifications (Mandatory):

  • Bachelor’s Degree in related discipline required.

  • Five years related experience in clinical research in an academic, government or pharmaceutical industry environment.

  • Demonstrated supervisory or lead responsibilities.

  • Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications:

  • Master’s Degree in a related field preferred.

Special Knowledge, Skills, or Abilities:

  • Must have a strong background in research methods, including database development/management, IRB submission, clinicaltrials.org submission, and participant recruitment and retention.

  • Extensive experience with clinical research sciences, regulatory affairs.

  • Extensive experience with protocol and informed consent writing and data analysis.

  • Prior experience managing clinical research staff.

  • Must be familiar with MS Access and MS Excel.

  • Excellent organizational skills required.

  • Excellent attention to detail skills required.

  • Ability to manage multiple and competing priorities.

  • Knowledge of clinical research practices and principles required.

  • Ability to understand a clinical trial financial contract.

  • Must have excellent time management skills.

  • Must have excellent oral and written communication skills.

  • Ability to work in a team and demonstrated interpersonal skills.

  • Knowledge of basic statistics.

JHU Equivalency Formula: _ 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience.  Additional related experience may substitute for the required education on the same basis. 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

Role/Level/Range: ACRP/04/MD

Starting Salary Range: $53,020 - $72,930 annually (commensurate with experience)

Employee group: Full Time

Schedule: M-F, 8:30 - 5:00 pm

Exempt Status: Exempt

Location: ​​​​​​​School of Medicine Campus

Department name: ​​​​​​​SOM Ped General Pediatrics

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.

Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons or because the individual is pregnant or attempting to become pregnant. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/ .

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

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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Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.

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