- 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.
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Research Nurse Specialist - Indianapolis, United States - Indiana Hemophilia & Thrombosis Center
Description
Job Description
Job DescriptionAbout IHTC
At the Indiana Hemophilia & Thrombosis Center (IHTC), 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 Research Nurse Specialist, you will be responsible for assistance with execution of research projects under the direction of the primary investigator or a Clinical Research Coordinator and for performing all tasks in accordance to study regulatory processes, standard operating procedures, and study protocols. This role is designed to help transition nurses from direct patient care into the clinical research field.
The Opportunity
This position requires occasional travel to outreach clinics throughout the state of Indiana.
Requirements
Benefits
Why join our team?
The IHTC is a not-for-profit program based in Indianapolis and offers a competitive salary and benefit package.
The IHTC is the only federally designated comprehensive hemophilia program in Indiana and serves the entire state through services available in Indianapolis and at outreach clinics.
The IHTC 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.
The IHTC 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 IHTC 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.
The Indiana Hemophilia and Thrombosis Center is an Equal Opportunity Employer.
