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Investigational New Drug & Investigational Device Exemptions Specialist

Dartmouth-Hitchcock Health
Lebanon, NH Full Time
POSTED ON 1/25/2024 CLOSED ON 4/3/2024

Job Posting for Investigational New Drug & Investigational Device Exemptions Specialist at Dartmouth-Hitchcock Health

Overview

REMOTE POSITION

 

Develops, conducts, and oversees the operational functions that support the IND/IDE activities of Dartmouth Health Sponsor-Investigators. Acts as a centralized resource for information, expertise, and support related to addressing the complex regulatory requirements, obligations, and responsibilities that govern the conduct of clinical research studies under investigator-sponsored Investigational New Drug (IND) applications and Investigational Device Exemptions (IDE).

Responsibilities

  • Manages the Office of Research Operations’ IND/IDE resources, including: FDA submission templates, the sponsor-investigator guidance documents, and specific IND/IDE training materials.
  • Initiates and leads the development of templates, tools, and guidance documents to support the development of the DH IND/IDE program.
  • Creates and leads IND/IDE educational offerings, providing necessary knowledge to DH researchers regarding the regulatory requirements, obligations, and responsibilities associated with the conduct of clinical research studies under investigator-sponsored INDs and IDEs.
  • Develops, reviews, and maintains IND/IDE related policies.
  • Maintains information regarding current regulatory landscape pertinent to the preparation and submission of investigator-sponsored INDs and IDEs and the conduct of clinical research studies under such FDA-accepted applications and exemptions.
  • Assists DH sponsor-investigators in determining if their protocol is exempt from FDA regulations.
  • Identifies expertise and facilities for the preparation of drugs and devices being evaluated under investigator-sponsored INDs and IDEs.
  • Oversees all components of the DH sponsor-investigator evaluation process.
  • Reviews all IND/IDE submissions to FDA, including but not limited to: initial application, progress reports, protocol amendments, safety reports, supplements, informational amendments, and final reports.
  • Guides DH researchers in achieving compliance with the regulatory requirements and obligations associated with the conduct of clinical research studies under investigator-sponsored INDs and IDEs.
  • Ensures institutional awareness of planned clinical research studies requiring the submission of investigator-sponsored INDs and IDEs and/or of planned services to support the submission of investigator-sponsored INDs and IDEs.
  • Ensures institutional awareness of the submission of investigator-sponsored INDs and IDEs and respective FDA communications.
  • Performs other duties as required or assigned.

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    Qualifications

    Minimum Qualifications:

    • Bachelor’s degree in one of biological sciences, nursing, or related health discipline. Master’s degree in health-related sciences preferred.
    • Minimum 5 years of experience supporting clinical trial initiation and conduct, and related regulatory work.
    • Expertise in Federal regulations governing Investigational New Drug and Device Exemptions required.
    • Experience submitting Investigational New Drug and Investigational Device Exemptions to the FDA required.
    • Experience training Principal Investigators and Research Staff in IND and IDE regulations preferred.
    • Strong competency in Microsoft Office required.
    • Excellent organizational skills with strong attention to detail required.
    • Strong analytical, interpersonal and oral/written communication skills required.

     

    Required Licensure/Certifications

    Required Licensure/Certification Skills:

    • Certified Clinical Research Professional (CCRP) or Certified Clinical Research Coordinator (CCRC) or obtained certification within the first year of hire.
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