Research Nurse Coordinator

Innovative Hematology, Inc.•Indianapolis, IN

12d•Onsite

About The Position

As a Research Nurse 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.

Requirements

Minimum Associate’s degree in Nursing.
RN or LPN license in the state of Indiana required
Minimum 5 years of related experience
Experience in pharmaceutical sponsored studies required
Valid Indiana Driver’s license and automobile insurance
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

Nice To Haves

Bachelor’s preferred

Responsibilities

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.