CLINICAL RESEARCH ASSOCIATE III, 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 2,600 faculty physicians and researchers, nearly 2,000 students, and more than 6,200 staff, the Duke University School of Medicine along with the Duke University School of Nursing, and Duke University Health System comprise Duke Health, a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Health Integrated Practice, Duke Primary Care, Duke Home Care and Hospice, Duke Health and Wellness, and multiple affiliations.

 

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 may have an opportunity to work remotely.  All Duke University and Duke Health remote 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

• Resource for study team on regulatory and contract processes

 

Study Training

• Provide study training and guidance to designated site personnel for conducting the study in accordance with the protocol, SOPs, trial specific procedures and applicable regulations. Anticipate potential situations that may affect subject safety or data processes and retrain site personnel to prevent issues.

• Train less experienced Site Management & Clinical Monitoring personnel for all types and complexities of monitoring activities and assessments including regulatory and other document activities.

Minimum Qualifications

 

 

 

Duke is an Affirmative Action/Equal Opportunity Employer committed toproviding employment opportunity without regard to an indiv idual's age,color, disability, gender, gender expression, gender identit y, geneticinformation, national origin, race, religion, sex, sexual orie ntation,or veteran status.

 

Duke aspires to create a c ommunity built on collaboration