General Nature or Purpose of Job: The Research Study Director will manage and coordinate several multicenter clinical trials supported by the Major Extremity Trauma and Rehabilitation Consortium (METRC). Under the direction of the METRC Coordinating Center (MCC) Director and Deputy Director Director(s) of the consortium, the Research Study Director is responsible for writing narratives for new grant submissions, developing research protocols, managing protocol committees, oversight of site performance, study enrollment and follow-up, data analysis and review.
Primary Duties and Responsibilities:
Functions independently and serve as a key contributor to study development and design for several multicenter studies.
Facilitates development of study protocols and data collection forms. This involves coordinating and managing protocol committee meetings, piloting data collection, and managing research staff within the coordinating center to deliver training on study procedures to research teams at participating centers.
Manage regulatory approvals, amendments, and annual progress reports for each study in accordance with local IRB and sponsor IRB policies.
Review, interpret, and integrate data from reports on enrollment, follow-up, and data quality for assigned studies.
Participate in the analysis and interpretation of study results and drafting study reports and papers.
Supervise 2-4 Study Managers and 1-2 Research Assistants.
Provide on-going technical and scientific guidance to the research staff and participating centers.
Serve on consortium working groups or committees as appropriate.
Attend scientific meetings, conferences and training courses to enhance job and professional skills.
Master’s degree in related discipline. Five years related experience.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
PhD in related discipline. Certification as a Clinical Research Professional.
Special knowledge, skills, and abilities: Proficiency in the use of software applications, databases, spreadsheets, and word processing required. Excellent organizational skills required. Excellent attention to detail skills required. Knowledge of clinical research practices and principles required. Must have excellent time management skills; must be able to manage multiple and competing priorities. Must have excellent oral and written communication skills.
Classified Title: Program Manager Working Title: Research Project Director Role/Level/Range: ACRP/04/ME Starting Salary Range: $70,000-$80,000 (commensurate with experience) Employee group: Full Time Schedule: Monday through Friday Exempt Status: Exempt Location: 05-MD:School of Public Health Department name: 60004105-Health Policy & Management -METRC Personnel area: School of Public Health
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