Cardiovascular & Thoracic
Coordinate and perform study specific regulatory processes across multiple studies of different therapeutic areas and phases, in accordance to appropriate regulations,Standard OperatingProcedures (SOPs), and study specific protocols/plans and processes.
- Build and maintain effective relationships with key study personnel.
- Assure compliance of general and study specific regulatory related processes with SOPs, FDA,NIH, and applicable regulations for the reporting of events to regulatory agencies.
- Review study specific data listings and reports for quality and accuracy.
- Provide study specific reports to appropriate personnel per processes. Develop appropriate regulatory reports and associated documentation in accordance with SOPs and study specific processes under the direction of Team Leader and/or Regulatory Supervisor.
- Primarily provides support for Phase 2, moderate investigator initiated and straight forward INDs.
- Provide routine updates and reporting to the Team Leader and/or Regulatory Supervisor to ensure timely communication regarding status of regulatory and/or safety related issues. Perform other regulatory related duties.
- Precept, mentor, and train regulatory personnel and others on regulatory and safety reporting regulations, processes, and procedures.
Perform other related duties incidental to the work described herein. The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Professional NC Medical License,when appropriate RAPS,ACRP, CCRC, CCRP, or SoCRA, is a plus.
1219 REGULATORY COORD
Job Family Level
Full Time / Part Time
Regular / Temporary
Duke University is an Affirmative Action/Equal Opportunity Employercommitted to providing employment opportunity without regard to anindividual's age, color, disability, genetic information, gender, genderexpression, gender identity, national origin, race, religion, sexualorientation, or veteran status.Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robustexchange of ideas—an exchange that is best when the rich diversity ofour perspectives, backgrounds, and experiences flourishes. To achievethis exchange, it is essential that all members of the community feelsecure and welcome, that the contributions of all individuals arerespected, and that all voices are heard. All members of our communityhave a responsibility to uphold these values.Essential Physical Job Functions:Certain jobs at Duke University and Duke University Health System mayinclude essential job functions that require specific physical and/ormental abilities. Additional information and provision for requests forreasonable accommodation will be provided by each hiring department.
1.Completion of a bachelor's degree2.Completion of an Associates degree plus a minimum of two years ofresearch and/or regulatory experience
Auto req ID
Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, genetic information, gender, gender expression, gender identity, national origin, race, religion, sexual orientation, or veteran status.
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.