Research Nurse Specialist
Indiana Hemophilia & Thrombosis Center
- Indianapolis, IN
- Permanent
- Full-time
- Participate in the planning and execution of research projects under the direction of the Medical Director, the primary investigator and the primary Clinical Research Coordinator if applicable.
- 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.
- Assist in assessing patients for inclusion and exclusion criteria to determine study eligibility, and work cooperatively with the comprehensive team to coordinate study-related patient care. May participate in informed consent process for study participants; document refusals according to protocol.
- Ensure accurate and prompt communication with patients, the primary investigator, research operations manager, clinical research coordinator, external contacts, study sponsors, and/or monitors.
- Create, update and/or assist with preparation of 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.
- Perform venipuncture; preparation of specimens; handling, packaging, and shipping of hazardous materials to the appropriate site(s).
- Assist with investigation product injections or infusions for study projects, as needed.
- Minimum Associate’s degree in nursing field required.
- Valid nursing licensure (RN, LPN, etc.) is required.
- Minimum 2 years of patient care experience required.
- Experience with pharmaceutical-sponsored studies or clinical research preferred.