Research Regulatory Coordinator

1 month ago

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

About IHI

At Innovative Hematology, Inc. (IHI), we offer a future where people with rare blood disorders flourish. Our experts provide the highest quality comprehensive services and holistic care to patients with bleeding, clotting and other hematologic disorders, and to their families.

What You Will Do

As Research Regulatory Coordinator, you will be responsible for initiating, coordinating, and leading all IRB and regulatory processes within the Research department. This role will also support the Research department in a variety of other capacities, including ongoing audit preparation and internal document creation and review as needed.

The Opportunity

  • Maintain IRB Tracker for all research studies within department
  • Prepare and process new submissions, amendments, continuing reviews, and study closures
  • Develop and create patient-facing study documents that comply with the selected IRB policies and procedures, FDA regulations, and sponsor requirements
  • Serve as primary contact with and for IRB related correspondence, including:
    • tracking responses
    • providing assistance & follow-up to IRB, Sponsor(s), & research staff
    • distributing IRB approval documentation and post-meeting information to study sponsors, IHI Research staff/designated coordinator
  • Assist 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. Review prepared documents for accuracy and completeness, identify problems, and perform quality control based on standard operating procedures
  • Submit prepared documents in the applicable IRB systems. Ensure that the 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. Maintain working knowledge of regulatory affairs affecting IRB & Sponsor related requirements of IHI.
  • Research, regulatory, & special projects execution support as appropriate
  • Provide research operational support as needed (Comprehensive Clinic, etc.)
  • Other research-related tasks as assigned. (Eg: data entry, chart review study)

Requirements

  • Bachelor's degree in 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.

Benefits

Why join our team?

IHI is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package.

IHI houses the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics.

IHI is a leader in hemophilia care, education and clinical research and has a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services.

IHI participates in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions. The organization's research program provides patients access to new therapies, and an opportunity to improve care. Our center has more than 50 clinical research projects involving bleeding disorders, sickle cell disease, thrombosis and more.

Innovative Hematology, Inc. is an Equal Opportunity Employer.

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