Research Regulatory Coordinator
4 days ago
At Indiana Hematology & Thrombosis Center, Inc., we are seeking a highly skilled Research Regulatory Coordinator to join our team.
Job Summary:
The Research Regulatory Coordinator will be responsible for ensuring compliance with regulatory requirements and guidelines related to clinical research. This includes coordinating and leading all IRB and regulatory processes within the Research department, as well as supporting the Research department in various capacities.
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 and procedures, 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
- Assist in drafting, reviewing, and submitting informed consents/assents when applicable
- Review prepared documents for accuracy and completeness, identify problems, and perform quality control based on standard operating procedures
- Submit prepared documents in applicable IRB systems, ensuring regulatory submissions comply with Federal and State laws
- Report IHI IND annual study reports to FDA as needed
- Develop in-depth understanding of each study, FDA, GCP, and ICH Guidelines, and maintain working knowledge of regulatory affairs affecting IRB and Sponsor-related requirements of IHI
- Research, regulatory, and special projects execution support as appropriate
- Provide research operational support as needed (Comprehensive Clinic, etc.)
- Other research-related tasks as assigned (e.g., data entry, chart review study)
Requirements:
- Bachelor's degree in a related field required; equivalent real-world experience may be accepted in lieu of education requirements
- Prior experience as Research Coordinator and/or Regulatory Coordinator strongly preferred
- Experience working with pharmaceutical-sponsored studies preferred
Why Work with Us:
Indiana Hematology & Thrombosis Center, Inc. is a not-for-profit organization dedicated to providing comprehensive services and holistic care to patients with bleeding, clotting, and other hematologic disorders. We offer a competitive salary and benefit package, as well as opportunities for professional growth and development.
We are an Equal Opportunity Employer and welcome applications from diverse candidates.
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