Project Administrator will be responsible for start-up of a growing research program in the Johns Hopkins Division of Infectious Diseases. This individual must be well versed with institutional and external clinical research guidelines. Individual is required to have excellent interpersonal and organizational skills, as well as budget and program management experience. Develops an increasing understanding of polices that guide clinical research. Ensures projects adhere to Good Clinical Practices, ICH Guidelines, and IRB and FDA requirements. This person will work closely with principal investigators and other study staff to develop and implement protocols and ensure that study goals are met for multiple research sites. Communication between Johns Hopkins, Unitaid, and other partners is a priority. Will hire and supervise research staff for program.
Specific Duties & Responsibilities
Administrative and Financial Responsibilities:
Manages all the administrative aspects of the research, ensuring that Johns Hopkins investigators are complying with Unitaid requirements. Responsible for the administrative aspects of research. Develops standard operating procedures and Interprets operating policies.
Sponsored Projects Responsibilities:
Participates in the development and submission of the Unitaid project and other related proposals. Administrates pre- and post- award requirements and works closely with faculty and the Sponsored Projects Officers to revise and submit grants, maintain reconciled accounts, submit annual reports to Unitaid and related agencies, manage high-risk subawards, and oversee grant closeout for multiple millions of federal grant dollars.
Clinical and Animal Research Responsibilities:
Administrative implementation of research study protocols for faculty. Individual will collaborate with the PIs and oversee research teams to develop and maintain study SOPs, will communicate with the sponsor, IRB, CRU, specimen biorepository, offsite specimen testing labs, and all study collaborators. Develop subcontracts and SOPs with collaborating institutions as needed and ensure that subcontract terms are met.
Other related work:
As time and resources permit, other related scientific efforts may need administrative support as this program expands and integrates additional related projects. It would be expected to contribute when there is a similar scope of work and essential roles.
Essential Job Functions:
Hires, trains, and supervises clinical research study staff to perform research duties on clinically complex research protocols.
Monitors progress toward study goals. Reports on progress at study team meetings with both research staff and with the PI.
Develops and modifies study case report forms.
Implements office services including payroll, purchasing, petty cash administrating, and effort reporting for multiple PIs and study team members.
Maintains a petty cash account of $10,000 in support of multiple research protocols. Reconciles monthly and requests replenishment for study visit payments. Has performed in-service training for divisional staff about petty cash reconciliation procedures, and trained multiple new petty cash custodians from other divisions.
Prepares budgets for government research grants. Creates, monitors, and manages budgets for awarded grants.
Analyzes unit operating practices including record keeping, personnel requirements, creating new systems, and revising established procedures.
Preparation of financial and operation reports. Uses Enterprise Reporting / Analysis Reports to track operational expenses and regularly report to the Principal Investigators.
Organizes, coordinates, and participates in meetings and conference calls of other physicians, researchers, and assistants within the institution and outside the institution.
Assists in manuscript preparation. Prepares research findings for publication, and draft documents for publication. Electronically and manually submits draft documents for publication to various journals and medical conferences.
Locates and compiles information, references, and journal articles. Formats reports, posters, graphs, tables, records and other sources of information for posters, oral presentations, manuscripts, and grants.
Manages and organizes computer assistance including purchasing of software and hardware.
Work with study investigators to compile study data and generate reports from the database to be used for sponsor, FDA and IRB annual and semi-annual reports.
Responsible for all data entry from standardized case report forms and study charts. Tracks data entry to ensure completeness and integrity of study data. Corrects errors in data set when necessary. Maintains electronic records in secure database of chart reviews and any discrepancies noted during reviews.
Meets regularly with principal investigators and research team to review data accuracy and overall study progress. Responds in a timely manner to special projects or queries related to data. Reports to: Dr. David Thomas Supervises: Research Program Assistant II & Research Program Coordinator
Education: Master’s degree in Business, Public Health, Finance, or other closely related field required. Additional closely related experience may substitute for master’s degree, to the extent permitted by the JHU equivalency formula.
Experience: Requires a minimum of 5 years of project management experience, and experience participating in large clinical/research trial required. Experience working with Unitaid helpful.
Special Knowledge, Skills, and Abilities
Uses Microsoft Excel, Access, PowerPoint, and MS Word and other programs including Reference Manager. Able to translate documents from one format to another, including MS Word and Word Perfect. Uses spreadsheets, relational databases, statistical packages and graphic packages to assemble, manipulate and format data and reports. Creates web databases using REDCap software. Uses STATA statistical software package. In addition, uses HopkinsOne and COEUS for preparation of sponsored project proposals and maintenance of awards.
Classified Title: Project Administrator Working Title: Project Administrator Role/Level/Range: ACRP/04/MF Starting Salary Range: $70,805 - $97,435, Commensurate with experience Employee group: Full Time Schedule: Monday-Friday, 8:30am-5:00pm, Up to 37.5 Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 10002813-SOM DOM 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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The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
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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