School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate tr

The Government Trials & Network Trial Coor di nat o r (CTC) is respo n si b l e for perfor m i ng and i m pl e m enting a variety of independent duties in v olved in the organi z atio n , tr a i ning, oversight, docu m entation, conduct and clinical data review for clinical trials that are being m anaged by Duke Clinical Research Institute (DCRI). This work is done for ph

Perform routine and moderately complex on site and in house site assessments independently for clinical trials research. Perform complex on site and in house site assessments with direction. Use critical thinking skills to monitor sites' compliance with study, sponsor, organizational, and government guidelines. Collect, document, update, and report study information accor

The Sr. Analyst, IT Data Architect is responsible for providing business intelligence (BI) subject matter expertise to the DCRI. This role will require to work closely with key stakeholders, collect requirements, and produce deliverables in the form of data acquisition to semantic layer design, data reports, dashboards, or raw datasets that will be used to drive business

The DCRI Megatrials domain designs and operationalizes large global commercial clinical trials focused on evaluating new drugs/devices for regulatory approval. The team works directly with senior clinical and operational Executives at large global pharmaceutical sponsors to create a global operational plan including a protocol, risk based monitoring plan, quality data sur

Performs intermediate level pharmacokinetic (PK) and pharmacodynamic (PD) analysis for multi center phase I IV clinical trials and/or clinical research projects. Demonstrates technical expertise for Pharmacokineticist I roles. Must have demonstrated ability to help with PK/PD and Pharmacometric activities from planning, implementation through completion. Collaborates clos

The Sr. Analyst, IT DevOps Engineer is responsible for aligning IT Operations and Release Management through best practices. The DevOps Engineer streamlines team efficiencies via team collaboration, documentation and automation while leveraging current and future enterprise tools. Working closely with management, project teams and business partner, the DevOps Engineer wil

Develop, coordinate, and implement research and administrative strategies essential to the successful design, management, and completion of research projects and other activities on clinical trial methodologies conducted by the Clinical Trials Transformation Initiative (CTTI), a public private partnership co founded by the US Food and Drug Administration's (FDA's) Office

Performs a variety of activities involved in evaluating the extent to which clinical research processes and documentation are aligned with applicable regulations and study specific requirements. These evaluation activities are the foundation of DCRI's audit program. Additionally, this position involves other general quality management activities. NOTE This position may ha

The Associate Director, Security, Privacy and Compliance directs the strategic planning and organizational initiatives that support Duke's compliance with FISMA, GDPR, and other regulatory obligations in support of research. The successful candidate is multifaceted in privacy, security, risk, and regulatory disciplines with ability to contribute to a unified Governance, R

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate tr

School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nationas top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate tr