Regulatory Coord

Duke University School of Medicine, established in 1930, is a prestigious institution ranked sixth among U.S. medical schools. 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.

Performs study specific regulatory and safety reporting processes across multiple studies in accordance with appropriate regulations, institutional policies, standard operating procedures (SOPs), and study specific protocols and plans and processes under the direction of the supervisor. May oversee the work of junior staff and train or mentor others in institutional and regulatory compliance.

• Recognizes when typical agreements (MTAs, CDAs, DUAs, DTAs, etc.) are necessary and alerts appropriate parties.
• Prepares FDA regulatory submissions in collaboration with ORAQ, including development, submission, and maintenance of relevant documentation.
• Addresses FDA review and/or potential hold issues in collaboration with the Principal Investigator (PI); may train or oversee others.
• Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs; may train others.
• Maintains study level documentation for international studies; may develop resources and tools for management of international studies, and/or coordinate with other entities or offices.
• Prepares for and provides support for study monitoring and audit visits, including support for the reviewer and addressing and correcting findings; may train others.
• Develops or helps develop SOPs; maintains study level documentation for all studies, including complex studies; may train or oversee others.
• Contributes to the effective facilitation of team meetings to achieve predetermined objectives; may lead multidisciplinary meetings with various stakeholders.

• 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; may train or oversee others.
• Develops consent plans and documents for participants in a variety of studies; may train or oversee others.
• Develops and submits documentation for 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; may train or oversee others.

• Enters and collects data; 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 complex studies; recognizes data quality trends and escalates as appropriate; may develop tools for, and train others in, data quality assurance procedures.
• Recognizes and reports security of physical and electronic data vulnerabilities; may develop or review data lifecycle and management plans for multiple study protocols.
• Demonstrates and applies open science practices and the FAIR data principles; prepares data for deposit in repositories following publication or study closeout; locates and follows repository‑specific requirements to submit study data for sharing; may draft data sharing plans for clinical studies.
• Maps a protocol's data workflow including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.); may train or oversee others.
• Innovatively uses technology to enhance a research process; may train others.
• Develops reports on study progress for the PI and other…