Regulatory Research Coordinator

4 days ago

Indianapolis, Indiana, United States Indiana Hemophilia & Thrombosis Center, Inc. Full time
Job Description

About Indiana Hematology & Thrombosis Center, Inc.

We are a not-for-profit organization dedicated to providing comprehensive services and holistic care to patients with bleeding, clotting, and other hematologic disorders.

Job Summary

We are seeking a highly organized and detail-oriented Regulatory Research Coordinator to join our team. The successful candidate will be responsible for initiating, coordinating, and leading all IRB and regulatory processes within the Research department.

Key Responsibilities

  • Maintain accurate and up-to-date records of all research studies within the department.
  • Prepare and process new submissions, amendments, continuing reviews, and study closures in accordance with regulatory requirements.
  • Develop and create patient-facing study documents that comply with IRB policies, FDA regulations, and sponsor requirements.
  • Serve as primary contact for IRB-related correspondence, including tracking responses, providing assistance and follow-up to IRB, Sponsor(s), and research staff, and distributing IRB approval documentation and post-meeting information to study sponsors and IHI Research staff/designated coordinator.
  • Assist the Primary Coordinator to ensure files are continuously updated and prepared for internal and FDA audits.
  • Assist in drafting, reviewing, and submitting informed consents/assents when applicable.
  • Assist in reviewing protocols and other study documentation, reviewing prepared documents for accuracy and completeness, identifying problems, and performing quality control based on standard operating procedures.
  • Submit prepared documents in the applicable IRB systems, ensuring that regulatory submissions comply with Federal and State laws.
  • Report IHI IND annual study reports to FDA as needed.
  • Develop an in-depth understanding of each study, FDA, GCP, and ICH Guidelines, and maintain a working knowledge of regulatory affairs affecting IRB and Sponsor-related requirements of IHI.
  • Provide research operational support as needed, including Comprehensive Clinic support.
  • Perform other research-related tasks as assigned, such as data entry and chart review studies.

Requirements

  • Bachelor's degree in a related field required. Equivalent real-world experience may be accepted in lieu of education requirements.
  • Prior experience as a Research Coordinator and/or Regulatory Coordinator strongly preferred.
  • Experience working with pharmaceutical-sponsored studies preferred.

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