Clinical Research Nurse, Neurology

Indiana University School of Medicine Department of Neurology has a rich tradition in academic neurology with a national reputation in neurological education and neuroscience research. The department is located in the Indiana University Health Neuroscience Center, a state-of-the-art outpatient center uniting specialties involving nervous system disorders: Neurology, Neurosurgery, Physical Medicine and Rehabilitation, Neuropsychology, and Neuroradiology. It is also home to the main outpatient Neurophysiology laboratory at IU Health. The adjoining IU School of Medicine Neurosciences Research Building enables collaboration among clinicians, basic scientists, and clinician-scientists in an environment rarely achieved in academic medicine.

Responsibilities

• Assist Principal Investigator (PI) in protocol development, evaluation, and risk assessment; evaluate study design and risk to subject population; determine staff, facility, and equipment availability; assess study population availability.
• Design recruitment strategies for assigned studies; recruit subjects according to IRB/protocol-approved methodologies; obtain informed consent, including discussion of treatment and intervention alternatives; monitor enrollment goals and modify recruitment strategies as needed.
• Liaise with healthcare professionals to determine best recruitment practices; manage subject recruitment, including marketing, screening procedures, and enrollment.
• Ensure proper collection, processing, shipment of specimens, and documentation; communicate with laboratory, PI, and sponsor regarding laboratory findings; record and document protocol deviations; communicate changes in trials to PI and sub-investigators.
• Participate in preparation and negotiation of study budgets; reconcile study budget accounts.
• Review, critically evaluate, and comment on study contracts/agreements.
• Prepare and submit Institutional Review Board (IRB) documents (e.g., Informed Consent, advertisements, protocol, and protocol summaries).
• Schedule study-related meetings and training sessions; provide instruction to study team for specific assignments; educate staff on scientific aspects of studies; train ancillary staff on clinical studies or trials; monitor study team compliance with required procedures and Good Clinical Practice (GCP) standards.
• Manage research study inventory and supplies (e.g., medications, equipment, devices); maintain required compliance documentation.
• Compose and submit continuing review/amendments/close-out information; schedule and prepare for monitor visits; prepare for and respond to Sponsor and/or FDA audits.
• Stay up-to-date and maintain current knowledge of regulatory affairs/issues; maintain expertise through familiarity with clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.

Requirements

• Bachelor's degree in nursing plus at least 1 year of clinical nursing experience, OR
• Associate's degree in nursing plus at least 3 years of clinical nursing experience, OR
• High school diploma or equivalent (e.g., HSED or GED) with LPN plus at least 4 years of clinical nursing experience.

Qualifications

• Licensed Practical Nurse (LPN) – required upon date of hire.
• Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) Clinical Research Certification – preferred upon date of hire.

Skills

• Ability to simultaneously handle multiple priorities.
• Experience in a regulated environment.
• High commitment to quality.
• Ability to analyze and interpret financial data.
• Effective interpersonal skills and ability to build strong customer relationships.
• Ability to effectively communicate.
• Ability to move about the work environment and position oneself to operate laboratory equipment effectively.
• Ability to move objects weighing up to 25 pounds.
• Occasional work near moving mechanical parts.
• Ability to perform essential functions with or without accommodation.

Benefits

• Comprehensive medical and dental insurance.
• Health savings account with generous IU contributions.
• Healthcare and dependent care flexible spending accounts.
• Basic group life insurance paid by IU.
• Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death & dismemberment insurance.
• Base retirement plan with generous IU contributions, subject to vesting.
• Voluntary supplemental retirement plan options.
• Tuition subsidy for employees and family members taking IU courses.
• 10 paid holidays plus a paid winter break each year.
• Generous paid time off plans.
• Paid leave for new parents and IU-sponsored volunteer events.
• Employee assistance program (EAP).