CLINICAL RESEARCH ASSOCIATE, LEAD DCRI - ITO

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.

 

Position Summary

 

Provide leadership, through guidance and oversight, to the site management and monitoring team, in collaboration with the Project Leader. Manage the development, coordination, and implementation of site management and monitoring responsibilities for assigned projects, including trial-specific processes and systems. Daily supervision of the site management and monitoring team in accordance with contractual agreements, department guidelines, SOPs, applicable international, federal and state regulations, ICH guidelines, and project scope of work.

 

** 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, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut, Rhode Island, Vermont and Wisconsin.

 

Primary Responsibilities and Task

Study Organization and Oversight

Coordinate and lead site monitoring assignments and activities, ensuring the appropriate scheduling of pre-study, initiation, periodic, and close-out site visits within visit windows and according to the monitoring plan.

Define site selection and activation guidelines and related activities with the project leader, the principal investigator, and the sponsor. Approve sites in collaboration with the project leader and the sponsor.

Coordinate the development, use and maintenance of study-specific processes, related documents, templates and other site management, communication, monitoring and regulatory tools.

Coordinate with the Principal Investigators, Project Leaders and additional functional group leaders to utilize available DCRI tools to identify, classify and act upon risk indicators in support of risk-based monitoring strategies.

Define, assign, coordinate, oversee, and assess productivity of team members' daily activities according to trial-specific scope of work, budget and timelines.

Provide leadership and site management and monitoring expertise to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of site and project issues.

Identify resource needs and escalate to Project Leader and line manager.

Direct and prioritize team efforts and assess overall team progress against project timelines and metrics. Develop performance standards for project team. Identify and notify project leaders of emerging out of scope activities and study guidelines. Evaluate impact on resource needs, study processes, and related documents.

Provide guidance and oversight to CRAs and sites to maintain data integrity and quality documentation.

Ensure study is set up within CTMS and provide annotated trip reports and accompanying confirmation and follow-up letter templates as applicable.

Support implementation and oversight of risk-based monitoring strategies, leveraging data-driven analysis to proactively identify and resolve quality concerns.

Provide oversight of the setup, implementation, and maintenance of assigned studies within CTMS, including tracking tools and status reports. Provide annotated trip reports and accompanying confirmation and follow-up letter templates as applicable.

Review and approve team deliverables focusing on quality and timeliness o