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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Johns Hopkins University remains committed to its founding principle, that education for all students should be grounded in exploration and discovery. Hopkins students are challenged not just to learn but also to advance learning itself. Critical thinking, problem solving, creativity, and entrepreneurship are all encouraged and nourished in this unique educational environment. After more than 130 years, Johns Hopkins remains a world leader in both teaching and research. Faculty members and their research colleagues at the university's Applied Physics Laboratory have each year since 1979 won Johns Hopkins more federal research and development funding than any other university. The university has nine academic divisions and campuses throughout the Baltimore-Washington area. The Krieger School of Arts and Sciences, the Whiting School of Engineering, the School of Education and the Carey Business School are based at the Homewood campus in northern Baltimore. The schools of Medicine, Public Health, and Nursing share a campus in east Baltimore with The Johns Hopkins Hospital. The Peabody Institute, a leading professional school of music, is located on Mount Vernon Place in downtown Bal...timore. The Paul H. Nitze School of Advanced International Studies is located in Washington's Dupont Circle area.