About the Hiring GroupRTI's Center for Clinical Research is seeking qualified candidates for a full-time Principal Investigator/Senior Research Epidemiologist/Biostatistician based in Research Triangle Park, NC or as a domestic teleworker. The Center provides research leadership, study and trial design expertise, and biostatistical support for multi-center domestic and international clinical studies and research networks, with expertise in statistical design and analysis, randomized clinical trials, clinical project management, and governance/operations management for Administrative and Data Coordinating Centers. A Principal Investigator/Senior Research Epidemiologist/Biostatistician serves as the leader or co-leader of Coordinating Centers for multi-center, single and multi-protocol clinical studies, and provides long-range direction on research activities in the Center.
What You'll DoResponsibilities:- Serves as overall project leader for coordinating centers of multi-site clinical research projects, including randomized clinical trials.
- Provides senior leadership for operational and scientific aspects of the project, including study/trial design, protocol development, study implementation, site oversight, quality control, data analysis, and presentation of study results.
- Typically serves as a member of a research network steering committee and as the primary liaison with the funding agency/client and the Data and Safety Monitoring Board.
- Guides and assists multi-disciplinary project teams in the operational aspects of the coordinating center, including data management and potentially clinical center subawards.
- Maintains effective communication with funding officials, study site leadership, collaborators from universities and other organizations, central laboratories, clinical centers, and other specialized core facilities such as specimen storage or imaging.
- Functions as the most senior point of escalation within a project, e.g., the coordinating center and/or research team.
- Oversees contractual and fiscal aspects of the Coordinating Center (e.g., ensuring timely reporting and deliverables, maintaining an adequate and appropriate staff mix for all project activities).
- Leads business and proposal development activities for grant, cooperative agreement, and contract opportunities, including supplemental funding and other growth opportunities.
- Leads development of manuscripts for refereed journals and mentors junior investigators on manuscript and scientific presentations.
- Presents research findings at scientific conferences.
- Monitors overall process and quality of studies and/or activities.
- Accountable for adherence to project budget, timeline/schedule, and contractual deliverables
- Serves in a leadership role in strategic planning, business development, including writing and leading proposals, and staff mentoring.
What You'll NeedQualifications:- A doctorate in epidemiology, statistics, biostatistics or related field and at least 12 years' experience working in multi-center clinical research, including randomized clinical trials.
- Proven track record in successfully leading or co-leading large complex public health research projects, including multi-site coordinating centers.
- Experience in obtaining funding and leading National Institutes of Health and other federally-funded research projects is strongly preferred.
- Demonstrable track record of leadership in developing and sustaining a climate that fosters growth in research funding, staff capabilities, and scientific excellence and reputation.
- Focus in 1-2 research areas of chronic or acquired health conditions, as evidenced by leadership experience and a corresponding record of scientific stature is preferred.
- Experience leading multi-disciplinary teams including senior, mid-level and early-career researchers, statisticians, data managers, technologists, and research coordinators/project managers.
- Experience leading FDA-regulated trials, including new drug and device studies is beneficial.
- A record of scientific stature in presentation and publication of study results in peer-reviewed journals and other venues.
- Experience in developing business and working with clients that fund research in public health, including federal agencies, private foundations, and/or the commercial sector.
- Experience working with sites (domestic/international sites), data sharing, and data use is beneficial.
- Experience with artificial intelligence/machine learning approaches is beneficial.
- Excellent skills in communication, negotiation, compromise, and building consensus within and between groups of various backgrounds.
- To qualify, applicants must be legally authorized to work in the United States and should not require now, or in the future, sponsorship for employment visa status.
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Hiring Salary Range$197,000 - $241,000
