CLINICAL RESEARCH COORDINATOR - For Hire Only

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.

Occ Summary

Participates in or lead day to day operations of clinical researchstudies conducted by principal investigator(s) at Duke Health; performsa variety of duties involved in the collection, compilat ion,documentation, and analysis of clinical research data. May oversee t hework of junior staff and train or mentor others in clinical researchta sks.

Work Performed

Research OperationsRecognizes whe n typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) arenecessary and alerts appropriate parties.May prepare Federal Drug Administration (FDA) re gulatory submissions incollaboration with Office of Regulatory Affairs a nd Quality (ORAQ),including development, submission, and maintenance of relevantdocumentation. Addresses FDAreview and potential hold issuesin collaboration with the Principal Investigator (PI).Knowledgeable in regu latory and institutional policies and processes;applies appropriately in study documentation, protocol submissions, andstandard operating proced ures (SOPs).Is responsible for all aspects of managing and documentingIn vestigational Product (IP); including arrival, storage, tracking, andpro vision to research participants. Serves as the primary liaison withspons ors, Investigational Drug Service (IDS), and other parties asnecessary. Follows protocol schema for randomization and blinding andunbinding.May maintain study level documentation for international studies anddevelop resources and tools for management of international studies, andcoordina te with other entities or offices.Prepares for and provides support for study monitoring and audit visits,including support for the reviewer. Ad dresses and corrects findings.Maintainsparticipant level and study leve l documentation for allstudies, includingthose that are complex in natu re (e.g., proceduraland interventional studies) and require access to th e Duke electronichealth record (EHR).Employs and may develop strategies to maintain recruitment and retentionrates and evaluate processes to ide ntifyproblems. Escalates issues.Screens participants for complex studie s (e.g., procedural andinterventional studies).Develops or helps develop SOPs.Collects, prepares, processes, ships, and maintains the inventory ofhuman research specimens, primarily thoserequiring complex procedures .Conducts activities for study visits in compliance with the protocol.Co ntributes to the effective facilitation of team meetings to achieveprede termined objectives. May lead multidisciplinary meetings withvarious sta keholders.Safety and EthicsIdentifies all AEs, and determines whether or not they are reportable.Collaborates with the PI to determine AE attrib utes, includingrelatedness to study.Conducts and documents consent for p articipants for all types ofstudies, including those that are complex in nature and require anyorders in Maestro Care.Develops consent plans and documents for participants in a variety ofstudies.Develops and submits documentation and information for InstitutionalReview Board (IRB) review . Communicates with the IRB staff and reviewersand handle issues appropr iately.Prepares and submits documents needed for regulatory and safetyre porting to sponsors and other agencies.Responsible for adherence to clin ical research policies to ensureethical conduct and protect vulnerable p opulations.Communicates the difference between clinical activities and r esearchactivities, and the risks and benefits of study participation tor esearch participants.DataEnters and collects data, and develops data ent ry or collection SOPs ortools. May provide oversight or training to stud y team memberscollecting or entering data.Ensures accuracy and completen ess of data for all studies, includingthose that are complex in nature. Recognizes data quality trends andescalates as appropriate. May develop tools for, and train others in,data quality assurance procedures.Recogni zes and reports security of physical and