Clinical Research Nurse, Pediatric Hematology/Oncology

About the Role

This role will specifically support Hematology and Oncology trials, including Sickle Cell Disease, Von Willebrand Disease, Lymphoma, and Solid tumor trials. The Clinical Research Nurse 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 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
• 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, 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 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

Education & Experience

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

Licenses & Certifications

• Required: Licensed Practical Nurse (LPN) upon date of hire
• Preferred: Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire

Required Skills

• 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

Pay & Schedule

Indianapolis, Indiana — $75,000.00 - 85,000.00 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

• 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)