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 2,500 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.

Occ Summary

Participates in or leads day to day operations of clinical research studies conducted by Principal Investigator(s) (PI) at Duke Health; performs a variety of duties involved in the collection, compilation, documentation, and analysis of clinical research data. May oversee the work of junior staff and train or mentor others in clinical research tasks.

Work Performed

Research Operations Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties. May prepare Food and Drug Administration (FDA) regulatory submissions in collaboration with Office of Regulatory Affairs and Quality (ORAQ), including development, submission, and maintenance of relevant documentation. Addresses FDA review and potential hold issues in collaboration with the PI. Knowledgeable in regulatory and institutional policies and processes; applies knowledge appropriately in study documentation, protocol submissions, and standard operating procedures (SOPs). Is responsible for all aspects of managing and documenting investigational product (IP); including arrival, storage, tracking, and provision to research participants. Serves as the primary liaison with sponsors, Investigational Drug Service (IDS), and other parties as necessary. Follows protocol schema for randomization and blinding or unblinding. May maintain study level documentation for international studies and develop resources and tools for management of international studies, and coordinate with other entities or offices. Prepares for and provides support for study monitoring and audit visits, including support for the reviewer. Addresses and corrects findings. Maintains all participant and study level documentation for studies that are complex in nature (e.g., procedural and interventional studies) and require access to the Duke electronic health record (EHR). Employs and may develop strategies to maintain recruitment and retention rates and evaluate processes to identify problems. Escalates issues. Screens participants for complex studies (e.g., procedural and interventional studies). Develops or helps develop SOPs. Collects, prepares, processes, ships, and maintains the inventory of human research specimens, primarily those requiring complex procedures. Conducts activities for study visits in compliance with the protocol. Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders. Safety and Ethics Identifies all adverse events (AEs), and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study. Conducts and documents consent for participants for all types of studies, including those that are complex in nature and require any orders in Maestro Care. Develops consent plans and documents for participants in a variety of studies. Develops and submits documentation for Institutional Review Board (IRB) review in iRIS. Communicates with the IRB staff and reviewers, and handles issues appropriately. Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies. Responsible for adherence to clinical research policies to ensure ethical conduct and protection of vulnerable populations. Communicates the difference between clinical activities and research activities, and the risks and benefits of study participation to research participants. Data Enters and collects data, and develops data entry or collection SOPs or tools. May provide oversight or training to study team members collecting or entering data. Ensures accuracy and completeness of data for all studies, including those that are complex in nature. Recognizes data quality trends and escalates as appropriate. May develop tools for, and train others in, data quality assurance (QA) procedures. Recognizes and