Clinical Research Nurse, Pediatric Hematology/Oncology

Indiana University; Indianapolis (IN); On-site; USD 75,000 - 85,000; Full time

Benefits offered by this job

Medical and dental insurance

Health savings account

Flexible spending accounts

Life insurance

Retirement plan

Tuition subsidy

Paid holidays

Generous paid time off

EAP

Job summary

Indiana University in Indianapolis seeks a Clinical Research Nurse to support Hematology and Oncology trials, including SCD, Von Willebrand disease, lymphoma and solid tumors. You will initiate, monitor, and coordinate studies, assist the PI with adverse events, and report data to sponsors and regulatory bodies.

Responsibilities include IRB handling, recruitment, enrollment, data management, and budgeting. The role requires an RN with licensure and relevant clinical research experience;

Qualifications

• 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 GED with LPN plus 4 years of clinical nursing experience.
• LPN license required by date of hire; ACRP or SOCRA clinical research certification preferred.

Responsibilities

• Assist PI, evaluate risk, and review study design for safety and feasibility.
• Design recruitment strategies, enroll subjects, and obtain informed consent.
• Coordinate data collection, specimen handling, and regulatory reporting.
• Monitor study budgets and manage study inventory and supplies.
• Prepare IRB submissions and monitor protocol compliance and audits.

Skills

Ability to simultaneously handle multi

Experience in a regulated environment

Demonstrates a high commitment to质量

Ability to analyze and interpret data

Effective interpersonal skills

Ability to build strong customer rela

Education

Bachelor's degree in nursing + 1 year clinical nursing experience

Associate's degree in nursing + 3 years clinical nursing experience

High school diploma or GED with LPN + 4 years clinical nursing experience

Job description

Department PED-HEMATOLOGY/ONCOLOGY (IN-PHEM-IUINA)

The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of Indiana University 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.

Job Summary

This role will specifically support Hematology and Oncology trials. These trials include Sickle Cell Disease, Von Willenbrand Disease, Lymphoma, and Solid tumor trials. The Clinical Research Nurse role initiates, conducts, monitors, and coordinates clinical studies or trials, assists the principal investigator (PI) with adverse events, reports data, and submits reports to study sponsor.

Department-Specific Responsibilities

• Ensures clinical data is assessed and reported correctly to sponsor and all regulatory authorities.
• Coordinates the collection and processing of pharmacokinetic samples.
• Evaluates and develops processes for study procedures and finds solutions to problems that impede the successful conduct and completion of clinical research trials.

General Responsibilities

• Assists 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 / Work Experience

Required
Bachelor's degree in nursing plus 1 year of clinical nursing experience; ORAssociate's degree in nursing plus 3 years of clinical nursing experience; ORHigh school diploma or GED with LPN plus 4 years of clinical nursing experience

Licenses AND Certificates

Required
LPN Licensed Practical Nurse 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

Work 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.

Work Location

Indianapolis, Indiana

Advertised Salary

$75,000 - $85,000 annually (determined by education, experience, knowledge, skills, and abilities, as required by the role, as well as internal equity and alignment with market data)

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: Career
FLSA: Exempt
Job Function: Research
Job Family: Clinical Research
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Posting Disclaimer

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. If you wish to include a cover letter, you may include it with your resume when uploading attachments.

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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