Tired of working long shifts with an overwhelming patient load? Come work at Indiana University: School of Medicine where you can make a difference in medicine, working with a smaller number of patients and having work/life balance. Our nurses build long-lasting, mutually beneficial relationships with their patients, physicians, and research staff alike. They are always striving to find the best care which best fit the individual needs of the patient.
The IU Division of Gastroenterology & Hepatology has a distinguished tradition of excellence in patient care and innovation in research and education. Consistently ranked among the top 15 units nationally by US News and World Report, we are one of the largest divisions in the country with enormous breadth to our clinical and research expertise.
This position is posted as a Clinical Research Nurse but may be filled as a Certified Clinical Research Nurse, depending on the candidate’s qualifications. Although they will be similar, the duties and responsibilities may differ if filled at the lower rank. Please see the Requirements Section below for the qualifications listed for each level.
Initiate, conduct, complete, and report clinical studies/trials. Assign and coordinate activities of study sites to ensure protocol, regulatory and standard operating procedures (SOP) and Good Clinical Practice (GCP) compliance. Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.
Clinical Research Nurse I:
Solicit industry-sponsored trials through contacts and professional organizations. Access and extract information for protocol development for investigator-initiated trials. Summarize literature review for study hypothesis.
Participate in protocol development or review of risk assessment. Evaluate the protocol, study design and risk to subject population. Determine staff, facility, and equipment availability, and assess study population/availability. Liaison with health-care professionals/providers to determine best recruitment practices for study.
Review, critically evaluate and comment on study contracts/agreement. Schedule and/or coordinate pre-study site visits of sponsor/s. Prepare and submit Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary). Prepare regulatory documents for sponsor.
Develop advertising and other information materials for recruitment. Identify and schedule screening procedures and review results. Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria.
Extract data from source documents. Order and receive drug/device supplies. Dispense drug/device supplies (calculate dosage as needed). Maintain files of drug/device dispensation, compliance and return.
Ensure proper collection, processing, shipment of specimens, and documentation. Communicate with laboratory, Principal Investigator, and sponsor regarding laboratory findings. Complete Case Report Forms (CRF) or database entries. Audit for accuracy and correct CRFs. Resolve sponsor queries. Provide/create source documentation tools for subjects' charts/records. Review incoming subject adverse event (SAE) information and assist PI in making submission determination of SAEs. Maintain follow-up to determine resolution of adverse event. Capture and record adverse events data. Compose adverse event reports for oversight agencies.
Compose and submit continuing review/amendments/close out information. Schedule and prepare for monitor visits. Prepare and respond to Sponsor or FDA audits. Audit documents and pertinent files and prepare for storage. Archive documents for study per sponsor/government/institutional requirements. Evaluate team effort at site. Document
Internal Number: 73445
About Indiana University
Founded in 1820, Indiana University is the state’s public university system, comprised of two core campuses—IU-Bloomington and IUPUI—and six regional campuses located throughout the state. Combined, the total student population is more than 114,000 undergraduate, graduate and professional school students. IU is one of the largest employers in the state, with over 20,000 faculty and staff. Indiana University is an equal employment and affirmative action employer and a provider of ADA services. Diversity and inclusion remains a core commitment to IU’s mission to cultivate an educational environment that supports equal access, participation and representation on all of its campuses and that provides educational and career opportunities for all.