Research Coordinator

4 days ago

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

We are seeking a highly motivated and detail-oriented Research Coordinator to join our team at the Indiana Hemophilia & Thrombosis Center, Inc. The successful candidate will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance with study regulatory processes, standard operating procedures, and study protocols.

Key Responsibilities
  • Project Planning and Execution: Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator.
  • Research Team Collaboration: Function as an integral part of the research and comprehensive care teams, working with colleagues to meet deadlines and maintain a flexible schedule based on the needs of patients, the department, and the IHTC.
  • Study Budgeting and Financial Management: Create a study budget in InfoED in collaboration with the finance department. Work with the finance department to assist with billing, invoicing, tracking status on payments due or past due, documenting patient stipend requests, and charting completed study visits.
  • Patient Assessment and Care Coordination: Assess patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. Explain informed consent for each study participant; document refusals according to protocol.
  • Communication and Documentation: Ensure accurate and prompt communication with patients, the primary investigator, research manager, external contacts, study sponsors, and monitors. Prepare study-related documentation such as protocol worksheets, procedural manuals, drug dispensation records, regulatory forms, adverse event reports; submit all relevant study documents to the institutional review board.
  • Compliance and Quality Assurance: Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional policies. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
  • Adverse Event Reporting: Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
  • Internal Quality Assurance: Participate in internal quality assurance; review monitor reports for trends across studies.
Requirements
  • Education: Minimum Associate's degree in a related field required.
  • Experience: Minimum 1 year of related experience required.
  • Driver's License and Insurance: Valid Indiana Driver's license and automobile insurance required.
Benefits

The Indiana Hemophilia & Thrombosis Center, Inc. is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package. We are a leader in hemophilia care, education, and clinical research, and have a dedicated on-site multidisciplinary staff to ensure availability of a wide range of required services. We participate in national and international clinical research, including new infusion products and therapies, investigation of long-term outcomes, and the impact of associated conditions.

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