Clinical Research Nurse

Indiana University; Indianapolis (IN); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

HSA

Life insurance

Disability insurance

Retirement plan

Tuition subsidy

Paid holidays

Paid time off

Employee assistance program

Job summary

Indiana University in Indianapolis seeks a dedicated research nurse to support the Family Medicine trials. The role involves protocol development, recruitment, consent, and regulatory documentation in coordination with the Principal Investigator and sponsors.

You will manage study budgets, ensure GCP and IRB compliance, and liaise with healthcare providers. A nursing degree with relevant clinical research experience is required.

Qualifications

• 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.

Responsibilities

• Assist PI and participate in protocol development and review of risk assessment.
• Recruit subjects according to IRB/protocol approved methodologies.
• Consent subjects and discuss treatment alternatives.
• Monitor enrollment goals and adjust recruitment strategies.
• Prepare IRB documents and ensure regulatory compliance.
• Manage study budgets and contract documents.
• Maintain inventory and prepare for audits.
• Provide training and education to study staff.

Skills

Prioritization

Regulatory experience

Quality mindset

Data interpretation

Interpersonal skills

Relationship building

Education

Bachelor’s degree in nursing

LPN with 4+ years experience

Associate’s degree in nursing

Job description

Department FAMILY MEDICINE (IN-FAMM-IUINA)

Department Information Family medicine is the medical specialty that provides continuing and comprehensive health care for individuals and families. This specialty integrates the biological, clinical and behavioral sciences and encompasses all ages and sexes, each organ system, and every disease entity. It is this combination that qualifies family medicine physicians to provide continuing and comprehensive medical care and health maintenance and preventive services to each member of a family regardless of patient type or problem be it biological, behavioral or social.Family medicine physicians, because of their background and interactions with families, are best qualified to serve as a patients advocate in all health-related matters, including the appropriate use of consultants, health services and community resources.

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; assesses study population/availability.Designs recruitment strategies for each assigned study; recruits subjects according to IRB/protocol approved methodologies; consents subjects including discussion of treatment and intervention alternatives; monitors enrollment goals and modifies recruitment strategy as needed.Liaisons 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, Principal Investigator, 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 Institutional Review Board (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 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

Required: 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 clinical nursing experience. OR High school diploma or equivalent (such as HSED or GED) with Licensed Practical Nurse (LPN) plus at least 4 years of clinical nursing experience.

LICENSES AND CERTIFICATES

Required: LPN Licensed Practical Nurse Upon Date of Hire.

Preferred: Association of Clinical Research Professionals (ACRP) or Society of Clinical Research Associates (SOCRA) Clinical Research Certification Upon Date of Hire.

SKILLS

Required: 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.

Additional Information

This position is grant funded.

Work Location

Indianapolis, Indiana

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)
• Learn more about our benefits by reviewing the IU Benefit Programs Brochure.

Job Classification

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

Equal Employment Opportunity

Equal Employment Opportunity Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.

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