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RESEARCH PROJECT MANAGER (Req ID: 58965)
Lead and coordinate the regulatory and reporting processes for investigators within the Institute or Center. In partnership with center/institute leadership, assist research teams in solving regulatory issues of moderate to complex scope, with an emphasis on those involving sensitive data and complex contractual arrangements. Coordinate with institute leadership and the Office of Research to ensure compliance with contractual arrangements and institutional/other policies. Collaborate with research contracting offices and technical partners at Duke and beyond, to determine and implement appropriate processes for managing compliant use of sensitive data for research.
Regulatory oversight and direction (50% effort)
Serve as an expert resource to multiple study teams within the institute regarding regulatory and institutional policies and processes. Recognize when agreements are necessary and help teams navigate between appropriate parties within the Duke environment and with external data providers and funders. Develop, oversee adherence, and train research teams within the institute in the use and development of workflows, tracking tools, and standard operating procedures (SOPs).
Provides regulatory oversight, training, and expertise for multiple study teams within the center or institute. Provide training and oversight to staff and faculty who develop and submit documentation to Institutional Review Board (IRB), information security offices, research contracting groups, and other internal/external parties. Assist in developing and submitting documentation on behalf of research teams as needed. Assist SSRI and individual research teams with regulatory reporting to sponsors and other agencies.
Recommend and lead individual research team implementation of improved processes, policies, and systems to ensure regulatory compliance and data security. May develop or review research data security plans (RDSPs) for multiple study protocols. Map, or help teams map, a protocol’s data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis.
Portfolio management (25%)
Assist SSRI leadership managing complex research portfolios. This includes predicting areas of vulnerability in regulatory requirements, data flow, data quality processes and data security. Help SSRI and individual study teams work through solutions.
Serve as liaison between central offices and SSRI. Provide reports to center and institute leadership, as well as the Office of Research, as needed.
Research process optimization and training (25%)
Recognize and escalate organizational or study level issues that could be optimized to improve research process. Actively facilitate and lead research teams’ adoption of change as policies and processes evolve. Uses advanced subject matter expertise in the areas of data/regulation to solve problems across multiple study teams. Train other to communicate effectively within teams and facilitate resolution of issues associated with teams or communication.
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