Clinical Research Nurse, Neurology

Indiana University; Indianapolis (IN); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Health insurance

Tuition subsidy

Paid holidays

Job summary

Indiana University Health Neurology Department seeks a Clinical Research Coordinator to support the Principal Investigator in protocol development, risk assessment, and study evaluation. You will recruit subjects, obtain informed consent, and ensure compliance with IRB requirements.

Responsibilities include budgeting, coordinating staff and facilities, training team members, and maintaining regulatory documentation to support high-quality neurological research at IU Health and the School of

Qualifications

• Nursing degree with clinical experience in regulated settings.
• Experience in clinical research or trial coordination is preferred.
• Understanding of IRB processes and GCP standards.

Responsibilities

• Assist PI and participate in protocol development and risk assessment.
• Evaluate study design and risk to subjects.
• Determine staff, facility, and equipment availability.
• Recruit subjects according to IRB/protocol methodologies.
• Consent subjects and explain treatment options.
• Monitor enrollment goals and adjust recruitment strategies.
• Prepare and submit IRB documents and study budgets.
• Coordinate study meetings, training, and communications.

Skills

Multitasking

Regulated environment

Quality focus

Financial data analysis

Interpersonal skills

Customer relationships

Education

Associate's degree in nursing

High school diploma or GED with LPN

Bachelor's degree in nursing

Job description

Department NEUROLOGY (IN-NEUR-IUINA)

Department Information

The Indiana University (IU) 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 that unites all the specialties that involve nervous system disorders; Neurology, Neurosurgery, Physical Medicine and Rehabilitation, Neuropsychology and Neuroradiology. It is also home of the main outpatient Neurophysiology laboratory at IU Health. The adjoining IU School of Medicine Neurosciences Research Building enables clinicians, basic scientists and clinician-scientists to collaborate in an environment that is rarely achieved in academic medicine.

Job Summary

• Assists Principal Investigator (PI) and participates in protocol development, evaluation, and review of risk assessment
• Evaluates study design and risk to subject population
• Determines staff, facility, and equipment availability
• Assess study population/availability
• Designs recruitment strategies for each assigned study
• Recruits subjects according to Institutional Review Board (IRB)/protocol approved methodologies
• Consents subjects including discussion of treatment and intervention alternatives
• Monitors enrollment goals and modifies recruitment strategy as needed
• Liaison with health-care professionals/providers to determine best recruitment practices for study
• Manages subject recruitment including marketing, screening procedures, and enrollment
• Ensures proper collection, processing, shipment of specimens, and documentation
• Communicates with laboratory, PI, and sponsor regarding laboratory findings
• Records and documents protocol deviations
• Communicates with PI and sub-investigators about changes in the trial
• Participates in preparation and negotiation of study budget and reconciles study budget accounts
• Reviews, critically evaluates, and comments upon study contracts/agreements
• Prepares and submits IRB documents (i.e., Informed Consent, advertisement, protocol and protocol summary)
• Schedules study-related meetings and training sessions and provides instruction to study team for specific study assignments
• Educates staff regarding scientific aspects of study and trains ancillary staff regarding clinical studies or trials
• Monitors study team compliance with required study procedures and good clinical practice (GCP) standards
• Manages research study inventory and supplies (such as medications, equipment, devices) and maintains required compliance documentation
• Composes and submits continuing review/amendments/close out information
• Schedules and prepares for monitor visits; prepares and responds to Sponsor and/or FDA audits
• Stays up-to-date and maintains current knowledge of regulatory affairs and/or issues
• Maintains a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings

Qualifications

Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.

EDUCATION / WORK EXPERIENCERequired

• Associate's degree in nursing plus 3 years clinical nursing experience
• High school diploma or GED with LPN plus 4 years of clinical nursing experience
• Bachelor's degree in nursing plus 1 year of clinical nursing experience

LICENSES AND CERTIFICATESRequired

• LPN Licensed Practical Nurse upon date of hire
• Preferred ACRP or SOCRA Clinical Research Certification upon date of hire

SKILLSRequired

• Ability to simultaneously handle multiple priorities
• Experience in a regulated environment
• Demonstrates a high commitment to quality
• Ability to analyze and interpret financial data
• Effective interpersonal skills
• Ability to build strong customer relationships

Working Conditions / Demands

The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.

Benefits Overview

• 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)

Job Classification

Career Level: CareerFLSA: ExemptJob Function: ResearchJob Family: Clinical Research

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