CLINICAL RESEARCH COORDINATOR

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.

 

Be Bold

Operations: 

Screen participants independently and provide oversight and training to study team members who screen participants. May maintain subject level documentation for all studies independently. Provide oversight and training to study team members who maintain subject level documentation, including documentation in the EMR. Schedule participants and conduct visits for all studies independently. Train others to conduct and document visits and protocol-specific testing/interviews. Assist with development and follow procedures and documentation of study payment in timely fashion. Collect, prepare, process, ship, and maintain inventory of research specimens and train others in these tasks. Assist with management of IP. Employ the required system for handling, dispensing and documentation of IP for sponsored protocols. May be responsible for determining the best methods for handling IP for Investigator-initiated protocols, or coordinating with investigational pharmacies as necessary. Maintain appropriate documentation. Track IP compliance at the protocol-and subject level. Train staff to maintain exemplary documentation including regulatory binders, enrollment logs, patient registration in the system of record, subject level documentation, etc. Oversee maintenance of subject level documentation. Implement innovative solutions to maximize recruitment and retention Provide oversight to study team members who conduct and document consent for participants in a variety of studies. Serve as an expert resource with regard to conduct and documentation of consent. Provide direction to study teams with preparation for study monitoring or study audit visits. Address and correct audit/monitor findings. Oversee the collection of adverse event information Direct study team's compliance with submission and completion of AE Reports, according to institution and sponsor-specific prompt reporting requirements (timelines and forms) independently. Develop DUHS IRB documents such as consent forms, protocols, and continuing reviews independently and train other staff in these tasks. 

 

Ethics: 

Serve as a resource to unit or department to help staff and patients recognize the difference between clinical care and clinical management of research participants Train junior staff in the ethical conduct of research, and provide guidance in strategies used to maintain safety. Articulate, to study staff and research participants, the pathophysiology or reasoning for an individual protocol's inclusion and exclusion criteria. 

 

Data: 

Train others on study team in use of technologies and software, and in completion of ECRFs. Assist with the development of data collection documents to standardize process. Use EDC systems and enter data accurately. Use required processes, policies, and systems to ensure data security and provenance. Independently investigate incomplete, inaccurate or missing data/documents to ensure accuracy and completeness of data. Run summaries and reports on existing data Follow SOPs for data QA. Recognize when data agreements are necessary 

 

Leadership: 

Assign, review, and train others in various work responsibilities. Serve as a mentor to junior staff, including others with my title. Employ escalation and performance plans as needed. Lead study teams with regard to clinical research professional guidelines and code of ethics. Identify potential problems and risks to the participant, study, investigator, team, sponsor, and institution. Maintain training 

requirements and develop solutions to proactively ensure study team members' compliance with training requirements. Evaluate the need for cultural diversity and cultural competency in the design and conduct of clinical research. Make recommendations to investigative team. 

 

Study and Site Management: 

Determine and implement alternati