CLINICAL RESEARCH ASSOCIATE II - Onsite Monitor, DCRI*

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 translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations.

 

POSITION DESCRIPTION

                                                              Onsite Clinical Research Associate II

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Occupational Summary

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 surveillance/data collection and analysis strategy to ensure patient safety and data integrity.  These studies are international pivotal phase 3/phase 4 registration studies that are either for new drug approval or changes to an existing drug label.  The typical DCRI Megatrial collaborates with other DCRI functional groups (i.e. project leadership, site management and monitoring, clinical events committee, data management, statistics, data and safety monitoring committee, safety surveillance) as well as multiple vendors (i.e. IVRS, drug distribution, central core lab, central ethics committee, CRO and ARO). Megatrials team members are selected based on their ability to work independently in a complex, high pressure, cross –cultural environment across multiple time zones. They are charged with delivering a high quality program according to the Megatrials Guiding Principles. These principles speak to ensuring the enrollment of the right patient who gets the right drug with complete ascertainment of safety and efficacy data according to ICH-GCP.

 

** NOTE: This position will require travel and on-site monitoring work.  All Duke University and Duke Health workers must reside in one of the following states or districts:  Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio and New Hampshire.

 

 

Position Responsibilities

 

   Study Organization

 

• Assess adequacy of site personnel and facilities for study conduct.
• Work closely with study sites to complete study start-up by facilitating site regulatory document completion, regulatory approval and readiness to participate.
• Negotiate and complete contract process.

 

   Study Training

• Provide initial and ongoing study training and guidance to designated site personnel for conducting study in accordance with protocol, SOPs, trial specific procedures and applicable regulations via Investigator meetings, WebEx, telephone and email.
• Identify situations that may affect patient safety, data integrity or study processes and retrain site personnel accordingly.

 

  

 

   Site Management/Monitoring

 

• Perform routine and complex on-site and in-house site assessment for approximately 30-50 clinical sites with minimal to no guidance.  Act as primary study contact and guide site through study procedures.
• Review and approve site-specific Informed Consent Form templates.
• Manage and oversee continuing regulatory, contra