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REGULATORY COORD
Job Title: REGULATORY COORD
Job Code: 1219
FLSA: E
Job Level: 52
Revised Date: 05/01/2019
Job Family: JF 05
Occupational Summary
Perform 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/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.
Knowledgeable in regulatory and institutional policies and processes; applies appropriately in study documentation, protocol submissions, and SOPs.
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).
Prepares for and provides support for study monitoring and audit visits, including support for the reviewer.
Addresses and corrects findings.
May maintain study level documentation for international studies and develop resources and tools for management of international studies, and/or coordinate with other entities or offices.
May prepare Federal 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/or potential hold issues in collaboration with the Principal Investigator (PI).
Leads meetings that are multidisciplinary, including those with complex objectives.
Safety and Ethics.
Develops and submits documentation and information for IRB review.
Communicates with the IRB staff and reviewers and handle issues appropriately.
Develops consent plans and documents for participants for all types of studies, including those that are complex in nature.
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.
Prepares and submits AE documents needed for regulatory and safety reporting to sponsors and other agencies.
Recognize and employ the professional guidelines and code of ethics related to the conduct of clinical research.
Summarize and clarify for study teams, the professional guidelines and code of ethics related to the conduct of clinical research.
Data.
Enters, 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.
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 research data security plans (RDSPs) 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.).
Independently use and implement technology to enhance productivity or process.
Scientific Concepts.
Using scientific proposals from the PI, develops research protocols. Demonstrates a basic understanding of the elements of research study designs.
Site and Study Management.
Collects appropriate information to determine whether the study teams participation in a specific trial is feasible.
May make feasibility recommendations.
Ensures that studies are conducted in compliance with institutional requirements and other policies.
Follows, and may develop or implement, protocol specific systems and documents including process flows.
Prepares for, coordinates, and actively participates in site visits. Communicates effectively with sponsors and/or contract research organizations (CROs).
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.
Uses advanced subject matter expertise in the therapeutic area or clinical research to solve problems.
Navigates processes and people involved in Duke clinical research, demonstrates the organizational awareness, and has the interpersonal skills necessary to get work done efficiently.
May serve on committees and workgroups internal to Duke or externally in therapeutic area of research.
Demonstrates resilience and is adaptive to change.
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.
