Clinical Research Coordinator

Innovative Hematology, Inc.; Indianapolis (IN); On-site; USD 42,000 - 62,000; Full time

Job summary

Innovative Hematology, Inc. in Indianapolis, IN is seeking a Clinical Research Coordinator to execute research projects under the direction of the principal investigator and ensure compliance with study protocols and regulatory processes.

The role involves planning and coordinating research activities with the Medical Director and research team, preparing study documentation, and assisting with budgeting, billing, and patient coordination across multiple studies.

Qualifications

• Minimum Associate's degree in related field required.
• Minimum 1 year of related experience required.
• Valid Indiana driver's license and automobile insurance required.
• All IHI employees are expected to enable multi-factor authentication via their personal device.

Responsibilities

• Participate in planning and execution of research projects under supervision of the Medical Director and primary investigator.
• Coordinate with the research and care teams to meet deadlines and maintain flexible schedules based on patient and department needs.
• Create study budgets and assist with billing, invoicing, and tracking payments with the finance department.
• Explain informed consent and document refusals according to protocol.
• Ensure accurate communication with patients, investigators, study managers, sponsors, and monitors.
• Prepare protocol worksheets, regulatory forms, and adverse event reports; submit documents to IRB.
• Monitor activities for protocol compliance and prepare for audits by sponsors or regulators.
• Record adverse events and coordinate reporting to oversight agencies.
• Engage in internal quality assurance and review monitor reports for trends.

Education

Associate's degree in related field

Job 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 a Clinical Research Coordinator, you will be responsible for executing research projects under the direction of the primary investigator and for performing in accordance to study regulatory processes, standard operating procedures, and study protocols.

The Opportunity

• Participate in the planning and execution of research projects under the direction of the Medical Director and the primary investigator
• 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 IHI.
• 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
• 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
• 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
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices. Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies
• Participate in internal quality assurance; review monitor reports for trends across studies

Requirements

• Minimum Associate's degree in related field required.
• Minimum 1 year of related experience required.
• Valid Indiana Driver's license and automobile insurance required.
• All IHI employees are expected to enable multi‑factor authentication via their personal smart phone/smart device in order to access IHI systems as a requirement of the role.

Benefits

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