The Department of Epidemiology has an exciting career opportunity. The individual will serve as a member of a coordinating center team that oversees the management of study operations, data and quality control for large, multi-center clinical trials conducted by a network of 23 clinics across the United States. The trials are funded by the American Lung Association, NIH, and pharmaceutical/device manufacturers.
The Sr. Research Program Manager will manage the administrative and scientific implementation of the LEEP trial, a clinical trial of losartan for COPD, as well as participate in the conduct of other studies conducted by the network. The manager will work with the investigators to develop study protocols and work independently to develop SOPs, study training and advertising campaigns. The manager will serve as the primary liaison to the JHU IRBs and will work with clinical centers to obtain and maintain IRB approvals for the trials. The manger will directly supervise one or more research program coordinators, oversee the work of research assistants, administrative coordinators, and research program assistants at the coordinating center. In addition, the manager will monitor activities at clinical centers to ensure that protocol and data collection procedures are adhered to; identify protocol deviations; and advise clinical center personnel on reporting, and provide corrective training for over 20 clinical centers. The manager will communicate orally and through written materials with clinical center directors and personnel, study sponsors, and regulatory bodies.
Conduct site visits to clinical centers to monitor study conduct.
Manage quality assurance programs for LEEP.
Manage and monitor specimen collection, shipment, and analyses at central laboratories for the LEEP Trial.
Monitor the submission of HRCT images from clinical sites to central reading center.
Liaison with drug distribution center to ensure that study drugs are masked and labeled according to study specifications. Monitor drug supply throughout the network.
Work with clinical sites to ensure that all regulatory reporting requirements are met for the LEEP Trial, e.g., adverse events and IRB submissions.
Update study project officer at NIH regarding current status of the trial.
Answer protocol-related questions from clinic staff.
Create materials and reports for meetings and publications. Attend study meetings and prepare meeting minutes.
Participate in start-up procedures for new studies including design of data collection forms, drafting manuals of operations and informed consent statements, and manage procurement and distribution of study drug and supplies.
Use principles of project management to organize project workload and meet deadlines.
Manage the monitoring of data quality and regulatory compliance.
Manage certification of clinical center staff for study procedures.
Organize and work with study analysts to generate data status reports and clinic performance reports for funding agencies and IRBs.
Special projects will be assigned by principal investigators.
Serve on protocol committee for LEEP Trial.
Serve on writing committees responsible for preparing manuscripts detailing study results.
Master's degree in Public Health or related field required.
Eight years related experience including significant experience in field conducting large research projects.
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.
Special knowledge, skills, and abilities:
Must have proficiency in Microsoft applications for production of documents, spreadsheets, tables, and slides.
Must have excellent writing and editing skills, strong organizational skills, and ability to work independently and collaboratively.
One or more research program coordinators.
Classified Title: Sr. Research Program Manager Working Title: Sr. Research Program Manager Role/Level/Range: ACRP/04/ME Starting Salary Range: $60,342 - $83,034 (commensurate with experience) Employee group: Full Time Schedule: M-F 8:30 am - 5:00 pm Exempt Status: Exempt Location: 05-MD:School of Public Health Department name: 10001101-Epidemiology Personnel area: School of Public Health
The successful candidate(s) for this position will be subject to a pre-employment background check.
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