Under the supervision of the Research Associate, the Senior Research Program Coordinator II is responsible for coordinating the research activities of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) and Gastroparesis Clinical Research Consortium (GpCRC) for the Johns Hopkins Coordinating Centers. The Sr. Research Program Coordinator II will assist clinical center personnel with day-to-day questions concerning protocols, completion of data collection forms, study visits, and data entry. The Sr. Research Program Coordinator II will monitor site recruitment and performance, produce monthly performance reports, and perform bi-monthly data audits and edits. The Sr. Research Program Coordinator II will draft study protocols, informed consent documents, and data collection forms. The Sr. Research Program Coordinator II will be involved in IRB applications, and yearly progress reports to the IRB and the sponsor, as well as organizing documents for submission to the FDA.
Specific Duties & Responsibilities:
Monitor clinic performance through monthly performance reports, bi-monthly data audits and edits
Assist clinics with problems with form completion, data entry, and general questions about study operations
Monitor clinical center personnel and site certification
Draft protocols, manuals of operations, data collection forms, and template consent statements
Plan, organize, and create meeting agendas, materials, and draft minutes for various meetings, including: Steering Committee, Staff, Publications, etc.
Complete annual progress reports, NIH progress reports, and other regulatory reports
Assist in adverse event reporting to study group, FDA, and sponsor
Oversee ordering, tracking, and distribution of supplies to clinical centers.
Bachelor's degree in related discipline.
5 years related experience required.
Project coordination experience in NIH-grant supported setting a plus.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula***.
Related Master's preferred.
Applicants with knowledge of SAS, Stata, and/or REDCap are preferred.
Special Knowledge, Skills, and Abilities:
Highly effective verbal and written communication skills, strong organizational skills, excellent attention to detail required.
Ability to work in a team environment
Ability to manage multiple and competing priorities
Knowledge of clinical research practices and principles preferred.
Technical Qualifications or Specialized Certifications:
Proficient in MS Office applications: Word, Excel, PowerPoint, and experience with Adobe Acrobat.
***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 education/experience required for the respective job.
Classified Title: Sr. Research Program Coordinator II Working Title: Sr. Research Program Coordinator II Role/Level/Range: ACRP/04/MC Starting Salary Range: $45,195-$62,225 (commensurate with experience) Employee group: Full Time Schedule: Monday-Friday/8:00am-4:30pm Exempt Status: Exempt Location: 05-MD:School of Public Health Department name: 10001101-Epidemiology Personnel area: School of Public Health
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