Research - Laboratory/Non-Laboratory, Staff/Administrative
The Johns Hopkins Department of Dermatology, Research Division seeks a Research Program Manager for a research program that includes the Cutaneous Translational Research Program (CTReP), which is a clinical and translational research unit with more than 40 IRB-approved ongoing clinical research studies (including phase 1 and 2 studies), and is utilized by more than 10 faculty and more than 20 residents. In addition, there are 3 basic science research laboratories. The clinical and basic research of the Department is funded by various different sources including the NIH, DoD, industry, foundation and internal departmental and institutional support.
The goal of the research program is to increase our understanding into the pathogenesis, diagnosis and treatment of skin disease to improve the care of patients. The research areas covered include a broad range of inflammatory, autoimmune and genetic disorders as well as cutaneous malignancies. In addition, the research program involves the training of residents, post-doctoral fellows, medical and graduate students in clinical and basic research to help them become the next generation of clinical and basic science researchers in dermatology.
Reporting to the Vice Chair for Research (primary) and the CTReP Director (secondary), the Research Program Manager will provide scientific, grants and contracts, budgetary, regulatory, reporting, data and statistical analysis support and other research responsibilities involving the clinical and basic science research activities of the Department. Manage the administrative and scientific implementation of research protocol for complex and/or multiple research studies. As part of study team, collaborate with faculty, develop protocol, develop SOP, and supervise study-related activities for one or more studies. Typically serve on executive committee and/or steering committee of large study. May manage staff at local site or be involved in management of sites at multiple locations. Supervise or oversee other exempt level research staff.
Scientific support. Provides support and collaborates with faculty, trainees and personnel in drafting/editing scientific content, including but not limited to specific sections of grants, contracts, manuscripts, research protocols, commentaries, editorials, review articles and book chapters. Involve in scientific discussions with collaborators, PI's, and funding organizations. Participate significantly in writing manuscripts and supervise data collection at single site study or at multiple sites of a multi-centered clinical trial.
Experimental support. Conducting, teaching and collaborating with personnel in laboratory-based experiments and assays for clinical and basic research projects.
Grants and contracts. Pre-award and post-award functions that includes, but may not be limited to: proposal preparation, submission, budget development, account maintenance and oversight, billing/invoicing, reporting, compliance, and closeout.
Budgetary. Develops budget for all of grants and contracts for sponsored research. Tracks and manages budgets and timelines to ensure all projects are on schedule and on budget.
Regulatory oversight. Working to ensure compliance with Office of Research Administration, Office of Human Subjects Research, Animal Care and Use Committee, FDA, Lab Safety, Biological Safety and Chemical Safety. Prepares standard operating procedures and oversees record keeping for auditing and monitoring visits.
Reporting. Provides support and submits progress reports, interim budgets reports, tracking and milestones for clinical and basic research activities.
Data and statistical analysis. Provides support in analyzing data and statistical analyses and facilitate external statistical analysis support.
Specific Duties & Responsibilities:
Works independently on a variety of complex level grants/contracts that range from simple to highly complex, including oversight of NIH grants, R01, R01/RFA, R34, K08, or K23, F32, T32, P50 multi-project and NSF, DOD and NASA. These grants, contracts and awards may involve highly detailed budgets, multiple projects, Cores and Sub awards, Investigator-initiated, Consortium and New Center Dept. of Defense grants, higher complexity Foundation grants and pharmaceutical company clinical trials.
Provides support and collaborates with faculty, trainees and personnel in drafting/editing scientific content, including but not limited to specific sections of grants, contracts, manuscripts, abstracts, research protocols, commentaries, editorials, review articles and book chapters. Utilizes scientific knowledge to edit scientific grants sections including specific aims, project summary, project narrative, and research strategy. Utilizes knowledge of departmental, institutional and grant submission requirements to edit and correctly format other grant sections, such as equipment, facilities and resources, human subjects, vertebrate animals, resource sharing, authentication of key biological and/or chemical resources and scientific rigor and reproducibility.
Provide instruction, preparation assistance and support related to grant application procedures. Assist with the day to day CTReP human research activities (IRB protocol preparation, maintaining supplies, devices instruments and scheduling study participants) as needed during staff transitions.
Independently conduct laboratory-based experiments included as part of the clinical studies in CTReP. Some occasional and limiting work may include conducting research in the basic science laboratories. These assays include but are not limited to: processing skin, tissue and blood samples, tissue and cell culture, immunohistochemistry, immunofluorescence microscopy, quantitative PCR, flow cytometry, ELISA, protein arrays, and isolating and purifying RNA/DNA for microarrays and sequencing.
Interpret data, write methods and protocols, perform statistical analyses and store data/records on the experiments performed. Collaborate and teach these assays to CTReP and other laboratory personnel.
Provide broad/in-depth professional administrative level guidance on protocols, regulations and guidelines to the principal investigator (PI) and other scientific/research professionals, both within the University and with other associated research/administrative professionals outside of the University.
Provide direction and assistance to the Senior Financial Analyst with details related to Sub awards from other institutions on their federal pass-through grants. May also work directly with management of non-sponsored funds, including general funds and gifts, on a limited basis. Serve as liaison between research units, central offices and funding agencies. Ensure compliance in all other areas related to grant and contract management, including sponsoring organization guidelines, internal protocols, accurate protocol information within grant documents, conflicts of interest, etc. Manage all assigned grant submissions to ensure timeliness and accuracy.
Maintain ongoing updates and communications related to current grants and contracts, this includes regular auditing and reporting to principal investigators on financial status of grants, contracts and discretionary accounts. Also provide relevant updates and reports to departmental leadership, as needed. Manage related post-award processes, including award setup, review, account setup verification, and ensuring that staff is setup appropriately. Ensure that post-award responsibilities are completed, including budget distribution, account reconciliation, e-form setup, effort reporting, cost transfers, paying invoices and paperwork finalization related to subcontract setup.
Oversee and direct all aspects of complex award management activities and provide oversight to other employees, including monitoring and managing accounts, audits, and evaluations and reporting.
Responsible for the timely preparation of budgets for pre-proposals, grant and contract submissions and for sponsors. Review budgets and related justification for appropriateness and completeness of content. Provide groundwork for subcontract negotiations. Tracks and manages budgets and timelines to ensure all projects are delivered on schedule and on budget. Supports research teams in developing timelines of assigned tasks and facilitate better coordination of the clinical and basic science research projects.
Analyzes expenditures and forecasts potential costs to assist in future budget preparations. Actively liaises with Department of Dermatology Director of Finance and Financial Analysts to integrate budgetary information.
Ensure the required research compliance training for faculty, trainees and personnel. Collaborating with the PI's and the JHU Office of Human Subjects Research and Animal Care and Use Committee to assist researchers in gaining approval of IRB protocols and Animal Research Protocols and move their protocols efficiently and quickly to completion. Coordinate with PI's to ensure all research conducted is according to approved protocols.
Provide support for FDA IND submission and FDA IND exemptions. Maintaining records and preparing for annual internal and external auditing and monitoring visits for CTReP (IRB, FDA, sponsors, others), Lab Safety, Biological Safety, Chemical Safety and Animal Research. In collaboration with researchers, prepares standard operating procedures. Ensures that research staff maintain records that well prepared for auditing and monitoring visits. Designs system procedures to ensure compliance with grant and institution regulations. Collects, reviews for adherence to regulation, and tracks all regulatory documentation. Ensure all regulatory compliance, documentation, and sponsor requirements are met.
Track activities, milestones, and deliverables, and report on a routine basis, and develop templates as needed to produce financial reports. In collaboration with the PI, plan, direct, and execute Annual Progress Report/non-competing and competing proposal submission process.
Monitors use of resources in accordance with project plans and budgets, and generates reports to the PI's to assist control of resources in their areas of responsibility, in a collaborative manner.
Data and Statistical Analysis:
Provides support to faculty and trainees in analyzing data and statistical analyses by utilizing knowledge of Graphpad/PRISM and Microsoft Excel.
Coordinate more sophisticated data analysis through JHU biostatistical resources (Institute of Clinical and Translational Research, Biostatistical Center [JHBC] and the Department of Biostatistics).
Bachelor's degree in related discipline. Related Master's preferred. Five years related experience. Demonstrated supervisory or lead responsibilities. Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
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 experience required for the respective job.
Preferred Qualifications: Master's degree. Significant experience in field conducting large research projects. Knowledge of accounting and budgeting theory and practices required. Knowledge and understanding of The Johns Hopkins University accounting system and related fiscal offices preferred.
Additional Knowledge, Skills, and Abilities:
Ability to make independent judgments and to act on decisions on a daily basis.
Ability to work with flexibility on several tasks simultaneously and to meet various concurrent deadlines.
Ability to work for long periods of time without direction.
Ability to prioritize own work.
Strong organizational skills, attention to details, analytical and problem solving ability.
Ability to effectively interact with all levels of University and Hospital employees as well as outside contacts.
Strong interpersonal and communication skills, both oral and written.
Classified Title:Research Program Manager Role/Level/Range: ACRP/04/MD Starting Salary Range: $52,495.00 - $72,210.00; Commensurate with experience Employee Group: Full Time Schedule: Monday - Friday, 8:00am - 5:00pm Exempt Status: Exempt Location: School of Medicine, East Baltimore Campus Department Name: Dermatology Research Division Personnel Area: School of Medicine
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