Clinical Research Nurse, Pediatric Clinical & Translational Research

PED-CLINICAL TRANSLAT RESEARCH (IN-PCTR-IUINA)

The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of IU School of Medicine (IUSM) to make Riley Children's Health Indiana's largest and most skilled pediatric system. At IUSM, our mission and core values define who we are, how we act, and what we aspire to accomplish. If you choose to join our team, you can expect a culture that values excellence, respect, integrity, diversity, and cooperation.

Department-Specific Responsibilities

• Manages multiple small to large projects from start to finish, ensuring on time completion within budget.
• Coordinates projects based on diabetes screening, monitoring, and collecting clinical samples for diabetes biomarkers.
• Ensures successful administration, operations, and financial management, establishes and drives execution of priorities, and provides systematic direction for study operations.
• Brainstorms and evaluates protocol, study design, and feasibility about recruiting strategies to implement to identify new potential study participants.
• Revises recruitment strategies as needed to ensure enrollment targets are met, monitors enrollment goals and modifies recruitment strategy as necessary.
• Develops project plan(s) and efficiently analyzes, tracks, forecasts, and reports on project metrics and shortfalls.
• Coordinates and facilitates efforts of project teams(s) consistent of various staff and hourly employees.
• Writes, submits, and revises regulatory and clinical research documents.
• Assists with clinical coordinator responsibilities as needed (such as participant consent, participant education, participant follow-up and simple participant visits).
  
  

General Responsibilities

• 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.
  
  

Required

EDUCATION / WORK EXPERIENCE

• Bachelor's degree in nursing plus 1 year of clinical nursing experience OR
• Associate's degree in nursing plus 3 years of clinical nursing experience OR
• High school diploma or equivalent (such as HSED or GED) with LPN plus 4 years of clinical nursing experience
  
  

Preferred

• Diabetes experience and experience coordinating large clinical studies requiring metabolic testing
  
  

LICENSES AND CERTIFICATES

Required

• Licensed Practical Nurse (LPN) upon date of hire
  
  

Preferred

• ACRP or 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
  
  

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.

This position is not eligible for visa sponsorship.

Indianapolis, Indiana

This position is eligible to work a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.

$55,000 - $65,000 per year based on of experience, skill level, education, and training.

32 hours per week, 0.80 FTE

For full-time staff employees, Indiana University offers a wide array of benefits including:

• 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.

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.

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Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University’s Notice of Non-Discrimination here which includes contact information.

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