Research Regulatory Affairs Coordinator Associate (FT), Pulmonary -CF-CTO

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Research/Science
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1900005K Requisition #
Position Summary:
 
Provides administrative support to Investigator and research division to prepare and submit study-related documentation to the IRB, industry sponsors, funding agencies and foundations, and applicable D-H and Dartmouth College research administration offices with limited supervision.  Prepares and provides various required progress reports to required entities.

 

Responsibilities:

  1. Assists with drafting, compiling, and maintaining essential records and documents required by DHMC and various sponsor organizations in compliance with applicable standards operating procedures for the execution of clinical trial operations including timely submission of informed consent forms and IRB packets meeting sponsor and departmental requirements
  2. Gathers information regarding all pertinent activity related to the protocol, including safety and protocol compliance information, within established guidelines
  3. Maintains current knowledge to be able to function as a resource to IRB members on regulatory and sponsor-related issues
  4. Maintains accurate and timely sponsor communications regarding status of research studies
  5. Maintains current in-depth understanding of federal, state and local rules regarding the conduct of research on human subjects
  6. Maintains an in-depth understanding of processes involving the IRB and CTO/OSP submission, renewal application and study closeout procedures
  7. Under direction of supervisor, collaborates with the IRB and DHMC Office of Compliance to ensure that clinical research activities are conducted in compliance with applicable FDA, OPHR, ICH, JC, and other regulatory guidelines
  8. Maintains and tracks on-site and off-site storage of required study records
  9. Assists in maintaining excellent, productive relationships with sponsor organizations.  Schedules and coordinates site visits, as assigned and tracks and ensures action items noted during site visits are completed and closed
  10. Maintains and tracks all required essential documents including but not limited to:  investigators’ CVs, medical licenses, CITI training, clinical laboratory certifications, etc.
  11. Tracks and documents status of subject enrollment and maintains subject follow-up trackers to ensure study compliance
  12.  Provides expertise to investigators, including departmental Fellows, for drafting and submitting individual research projects
  13. Maintains current understanding of process for  grant development and submission as needed
  14. Performs other duties as required or assigned
Minimum Qualifications:
  • Bachelor’s degree in basic science or health related field. 
  • Minimum of two years’ current clinical research experience. 
  • In lieu of educational requirement and previous clinical research experience, current level of education and background experience will be considered.
  • Clear and succinct verbal and written communication.
  • Professional deportment and the ability to communicate effectively with a wide variety of audiences.
  • Regulatory Affairs Certification (RAC) eligible within 2 years preferred
  • Certification through the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) eligible within 2 years considered.
  • Proficient with Microsoft’s Office Suite
 
Required Licensure/Certification Skills:
  • None.
 

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