The Johns Hopkins School of Medicine seeks an experienced Research Program Manager to work closely with Department of Pediatrics, Division of Adolescent/Young Adult Medicine in activities relating to supporting clinical research, program evaluation, and medical education specific to the Division’s gender affirming care program.Under limited supervision, job supports departmental research programs and/or clinical trials by coordinating protocol implementation and monitoring the collection of data for studies. The range of duties includes but is not limited to patient recruitment/ interviews, data collection, organizing collected information; records management, expenditure oversight, and communicating with team members on the status of project(s). The Program Manager, oversees and evaluates the performance of research assistants and coordinators supervises and observes and assesses work, provides feedback, trains and performs evaluations. Utilizes knowledge of theory and statistics and applies these skills to the administration of the scientific protocol and assigned projects.This position will manage all the technical aspects of operationalizing research protocols, post jobs, preview candidates, supervise your research coordinator, research assistants, and outreach staff, conduct performance reviews, ensure adherence to all regulatory processes for the research, and provide research program support to Gender Affirming Care Research and Educational Programming as well as HIV prevention research and educational program within the Division.Specific Duties & Responsibilities
Assist investigators in development and initial implementation of clinical research protocols. This may include Developing and managing study timeline and program management plan; assisting with the development of patient registries; supporting fellow, resident and student investigators.
Assist investigators with clinical and medical education program evaluation activities.
Coordinate interactions of clinical research programs across the divisions of the department of Pediatrics to facilitate collaborative efforts and activities.
Conduct independent literature searches and locate references for research projects.
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 of grant proposals and manuscripts (template and word processing aspects)
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.
Other duties as assigned.
Special Knowledge, Skills, or Abilities/Competencies
Excellent organizational skills required.
Ability to manage multiple and competing priorities.
Knowledge of clinical research practices and principles required.
Knowledge of program evaluation practices and principles.
Knowledge of basic statistics.
Knowledge of qualitative analysis methodologies.
Must have a strong background in research methods and participant recruitment.
Extensive experience with clinical research sciences, regulatory affairs
Demonstrated supervisory or lead responsibilities.
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.
Minimum Qualifications
Bachelor's Degree in related discipline. Related Master's preferred.
Five years related experience, including demonstrated supervisory or lead responsibilities.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
Classified Title: Research Program ManagerRole/Level/Range: ACRP/04/MDStarting Salary Range: $55,800 - $97,600 Annually ($75,000 targeted; Commensurate with experience)Employee group: Full TimeSchedule: M-F: 37.5 hrs per weekExempt Status: ExemptLocation: Hybrid/School of Medicine CampusDepartment name: SOM Ped Adolescent MedicinePersonnel area: School of MedicineEqual 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.
