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8283 - Clinical Research Nurse I

The Department of Neurological Surgery is seeking a Clinical Research Nurse. This position will 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.

Primary Responsibilities Include:

• 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. Assess study population/availability. • Identify potential subjects from review of existing protected health information based on Inclusion/Exclusion criteria. Determine appointments per protocol. Schedule subjects for appointments. • Schedule and prepare for monitor visits. Prepare and respond to Sponsor or FDA audits. • Contact outside health-care providers to obtain follow-up information. Communicate with subjects to obtain follow-up information. • Extract data from source documents. Complete Case Report Forms (CRF) or database entries. • Maintain current knowledge of regulatory affairs and/or issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings. Record and document protocol deviations. Communicate with PI and sub-investigators about changes in the trial. • Participate in preparation and negotiation of study budget. Reconcile study budget accounts with Business Manager.

To be successful in this position the candidate should have neuroscience/neurosurgical background, and in depth knowledge of data collection, database management, and demonstrated experience writing grant proposals and managing statistical analysis. This job requires effective organizational skills and the ability to manage projects from start to completion within strict deadlines; excellent writing, editing, oral communication, and interpersonal skills; the ability to complete funding documentation with accuracy and attention to detail; and the demonstrated ability to work with others in a team environment. Must possess significant understanding of regulatory affairs, and they impact the responsible conduct of research involving human subjects including FDA, GCP and institutional Standard Operating Procedures. Experience with IUPUI/IU Health IRB forms and submission process is preferred.

Required: Bachelor’s degree in Nursing from an accredited institution and one year of clinical nursing experience; or Associate’s degree in Nursing and three years of clinical nursing experience; or LPN/Diploma in Nursing and four years of clinical nursing experience. Current RN/LPN licensure required.

Indiana University is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, religion, age, sex, sexual orientation or identity, national origin, disability status, or protected veteran status. This institution is also a provider of ADA services.