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REGULATORY COORD
Job Title: REGULATORY COORD
Job Code: 1219
FLSA: E
Job Level: 52
Revised Date: 01/08/2024
Job Family: JF 05
Occupational Summary
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.
Work Performed
Research Operations
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 potential hold issues in collaboration with the Principal Investigator (PI).
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
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. Develops or helps develop SOPs.
Maintains study level documentation for all studies, including those that are complex in nature (e.g., procedural and interventional studies).
Contributes to the effective facilitation of team meetings to achieve predetermined objectives. May lead multidisciplinary meetings with various stakeholders.
Safety and Ethics
Identifies all AEs, and determines whether or not they are reportable. Collaborates with the PI to determine AE attributes, including relatedness to study.
Develops and submits documentation and information for IRB review. Develops consent plans and documents for participants for all types of studies, including those that are complex in nature. Communicates with the IRB staff and reviewers and handle issues appropriately.
Prepares and submits documents needed for regulatory and safety reporting to sponsors and other agencies.
Recognizes and employs the professional guidelines and code of ethics related to the conduct of clinical research.
Summarizes and clarifies the professional guidelines and code of ethics related to the conduct of clinical research for study teams.
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 procedures.
Recognizes and reports security of physical and electronic data vulnerabilities. May develop or review data lifecycle and management plans for multiple study protocols.
Maps a protocols data flow plan including data capture, storage, transfer, management, quality, and preparation for analysis (may include data from EDCs, EHR, mobile apps, etc.).
Innovatively uses technology to enhance a research process. Prepares tables, data visualizations, and lay summaries to communicate study results to participants.
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.
Scientific Concepts
Using scientific proposals from the PI, develops elements of research protocols.
Demonstrates and applies a basic understanding of open science practices and the FAIR data principals.
Demonstrates a basic understanding of the elements of research study designs.
Site and Study Management
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or CROs.
Uses clinical research management system and its reports to manage all protocol activities, including minimum footprint, SIP counsel, and all aspects of maintaining current protocol information. May train others.
Collects appropriate information to determine whether the study teams participation in a specific trial is feasible.
Ensures that studies are conducted in compliance with institutional requirements and other policies.
Follows, and may develop or implement, operational plans (e.g. protocol- specific systems and documents including process flows).
Prepares studies for closeout and document storage.
Leadership and professionalism
May train or oversee others in the above tasks. 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. May serve 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.
Required Qualifications at this Level
Education/Training
Completion of an Associate's degree
Experience
Work requires a minimum of two years of research and/or regulatory experience. A Bachelor's degree may substitute for 2 years of required experience.
Skills
Can easily use computing software and web based applications (e.g., Microsoft Office products and the electronic medical record).
The intent of this job description is to provide a representative and level of the types of duties and responsibilities that will be required of positions given this title and shall not be construed as a declaration of the total of the specific duties and responsibilities of any particular position. Employees may be directed to perform job-related tasks other than those specifically presented in this description.
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex, sexual orientation, or veteran status.
Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.
Essential Physical Job Functions
Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.
