Location: Baltimore, Maryland
Internal Number: 108231-en_US
The Johns Hopkins Department of Surgery Division of Transplantation has a Xenotransplantation research program that is utilized by faculty, postdocs and residents. The basic research of the Department is funded by various different sources including the NIH, industry, and institutional support. The goal of the research program is to study xenogeneic kidney transplantation in porcine to large animals and ultimately to humans. In addition, the research program involves the training of residents, post-doctoral fellows, medical and graduate students in basic research to help them become the next generation of science researchers in xenotransplantation.
We are seeking a Research Program Manager who will report to the Xenotransplantation Research Program Director (primary) and the Surgery Director (secondary) and will provide scientific, grants and contracts, budgetary, regulatory, reporting, data and statistical analysis support and other large animal research responsibilities to include anesthesia and intubation during large animal surges involving the science research activities of the program. This role will 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.
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 large animal research activities within the Xenotransplantation group (IRB protocol preparation, maintaining supplies, devices instruments and scheduling study participants) as needed during staff transitions.
- Independently conduct laboratory-based experiments
- Assist with large animal surgeries performing as an RVT anesthesia and intubation.
- 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 other laboratory personnel on GLP studies working with CRO.
- Will 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.
- May also work directly with Division Administrator 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 Division of Transplantation Administrator to integrate budgetary information.
- Working to ensure the required research compliance training for faculty, trainees and personnel.
- Collaborating with the PIs 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 PIs to ensure all research conducted is according to approved protocols.
- Providing 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 PIs to assist control of resources in their areas of responsibility, in a collaborative manner.
Data & Statistical Analysis
- Provides support to faculty and trainees in analyzing data and statistical analyses.
- 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, including demonstrated supervisory or lead responsibilities.
- Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
- Registered Veterinarian Technologist with experience in large animal anesthesia and intubation.
- 5yrs related experience including significant experience in field conducting large research projects.
Classified Title: Research Program Manager
Starting Salary Range: $54,080-$74,390-$94,710 Annually (Commensurate with experience)
Employee group: Full Time
Schedule: M-F 8 - 5
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM Sur Transplant Surgery
Personnel area: School of Medicine
The referenced salary range is based on Johns Hopkins University's good faith belief at the time of posting. Actual compensation may vary based on factors such as geographic location, work experience, market conditions, education/training and skill level. Johns Hopkins offers a total rewards package that supports our employees' health, life, career and retirement. More information can be found here: https://hr.jhu.edu/benefits-worklife/
Please refer to the job description above to see which forms of equivalency are permitted for this position. If permitted, equivalencies will follow these guidelines:
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 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.
**Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
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