Duke University · 1 day ago
REGULATORY COORD
Durham, NC
Full-time
Onsite
Entry, Mid Level
2+ years expDuke University School of Medicine is a leading academic medical center that emphasizes interdisciplinary collaboration in health research. The Regulatory Coordinator will perform study-specific regulatory and safety reporting processes, oversee junior staff, and ensure compliance with institutional policies and regulatory requirements.
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Responsibilities
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
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
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
Addresses and corrects findings
May train others
Develops or helps develop SOPs
May train or oversee others
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional 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 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 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 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 that ensure data and documentation will support re-use
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 study team members and collaborators
Creates clear visualizations to help communicate key information to stakeholders
Conducts rapid and/or in-depth qualitative analyses and summarizes findings
Critically examines and interprets unstructured/semi-structured data and rigorously explains findings in relation to the research context
Includes the use of qualitative data analysis software (e.g., NVivo, Atlas.ti) to code and categorize the data
May train others
Uses statistical tools (e.g. SAS, R, SPSS) to perform statistical analysis
Codes data using statistical tools to prepare for analysis under direct supervision from Biostatistician and PI
Independently conducts literature searches and reviews
Develops elements of research protocols using scientific proposals from the PI
Demonstrates a basic understanding of the elements of research study designs
Prepares for, coordinates, and actively participates in site visits
Communicates effectively with sponsors and/or CROs
Uses OnCore and eREG systems and system reports to manage research protocols
May train or oversee others
Collects appropriate information to determine whether the study team's participation in a specific trial is feasible
May make feasibility recommendations
Ensure that studies are conducted in compliance with institutional requirements and other policies
Follow, and may develop or implement, operational plans (e.g. protocol-specific systems and documents including process flows)
May train or oversee others
Prepares studies for closeout and document storage
May train or oversee others
Proactively seeks opportunities to add relevant skills and certifications to own portfolio
Keeps current with research updates by attending key external offerings (i.e. Research Wednesday, RPN, events outside of Duke, etc.) and applies the learned material to the job
May disseminate information to others
Serves on committees and workgroups internal to Duke or externally in therapeutic area of research
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently
Demonstrates resilience and is adaptive to change
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems
Communicates effectively with others, regardless of reporting relationship, to accomplish shared work objectives
Qualification
Required
Completion of an Associate's degree
Work requires a minimum of two years of research and regulatory experience
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs
Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record)
Preferred
Regulatory experience is preferred
A Bachelor's degree may substitute for 2 years required experience
Completion of the DOCR North Carolina state approved Clinical Research Apprenticeship program may substitute for one year of required experience
Company
Duke University
Duke University is a private research university providing undergraduate and postgraduate education in medicine and other disciplines.
10001+ employees
H1B Sponsorship
Duke University has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (274)
2024 (232)
2023 (202)
2022 (195)
2021 (148)
2020 (121)
Funding
Current Stage
Late StageTotal Funding
$71.15MKey Investors
North Carolina Biotechnology CenterUS Department of EnergyGlaucoma Research Foundation
2023-02-17Grant· $0.11M
2022-09-19Grant
2022-03-09Grant· $0.05M
Leadership Team
Barry Myers
Professor and Director
Dan Ariely
Professor
Recent News
2025-12-18
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