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Regulatory Research Specialist
2 months ago
About Indiana Hemophilia & Thrombosis Center, Inc.
At Indiana Hemophilia & Thrombosis Center, Inc., we are dedicated to enhancing the lives of individuals with rare blood disorders. Our team of specialists is committed to delivering exceptional, comprehensive services and holistic support to patients facing bleeding, clotting, and other hematologic challenges, along with their families.
Key Responsibilities
As a Regulatory Research Specialist, you will play a crucial role in initiating, coordinating, and overseeing all Institutional Review Board (IRB) and regulatory activities within the Research department. This position will also provide support to the Research department in various capacities, including preparation for audits and the creation and review of internal documents as necessary.
Core Duties Include:
- Maintain an up-to-date IRB Tracker for all research initiatives within the department.
- Prepare and manage new submissions, amendments, continuing reviews, and study closures.
- Develop and produce patient-facing study documents that adhere to the relevant IRB policies, FDA regulations, and sponsor requirements.
- Act as the primary liaison for all IRB-related communications, which includes:
- Tracking responses
- Providing assistance and follow-up to the IRB, sponsors, and research personnel
- Distributing IRB approval documentation and post-meeting information to study sponsors and designated research staff.
- Assist the primary coordinator in ensuring that files are consistently updated and ready for internal and regulatory audits.
- Support the drafting, reviewing, and submission of informed consent documents when applicable.
- Review protocols and other study documentation for accuracy and completeness, identifying issues and performing quality control in accordance with standard operating procedures.
- Submit prepared documents through the appropriate IRB systems, ensuring compliance with federal and state regulations.
- Report annual study findings to the FDA as required.
- Develop a comprehensive understanding of each study, as well as FDA, Good Clinical Practice (GCP), and International Council for Harmonisation (ICH) guidelines. Maintain a working knowledge of regulatory affairs impacting IRB and sponsor-related requirements.
- Provide support for research, regulatory, and special project execution as needed.
- Offer operational support for research initiatives as required.
- Perform other research-related tasks as assigned, such as data entry and chart review studies.
Qualifications
- A Bachelor’s degree in a relevant field is required. Equivalent practical experience may be considered in lieu of formal education.
- Prior experience as a Research Coordinator and/or Regulatory Coordinator is strongly preferred.
- Experience with pharmaceutical-sponsored studies is advantageous.
Why Join Us?
Indiana Hemophilia & Thrombosis Center, Inc. is a not-for-profit organization that offers a competitive salary and benefits package. We are recognized as a leader in hemophilia care, education, and clinical research, with a dedicated multidisciplinary team to ensure a wide range of essential services.
Our center participates in national and international clinical research, providing patients access to innovative therapies and opportunities to enhance care. We are involved in numerous clinical research projects addressing bleeding disorders, sickle cell disease, thrombosis, and more.
Indiana Hemophilia & Thrombosis Center, Inc. is an Equal Opportunity Employer.
