Pediatric Oncology Research Nurse — Hematology Trials

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 with IU contrib

Flexible spending accounts

Life insurance

Retirement plan with IU contributions

Tuition subsidy for IU courses

Paid holidays and paid time off

EAP

Job summary

Indiana University, Riley Hospital for Children, seeks a Clinical Research Nurse to support hematology/oncology trials. You will initiate, monitor, and coordinate clinical studies; assist the PI with adverse events; and report data to sponsors.

The role involves regulatory submissions, recruitment planning, specimen handling, and budget review. Requires a nursing degree with clinical experience; IU offers comprehensive benefits and a competitive salary in Indianapolis.

Qualifications

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

Responsibilities

• Assists PI and participates in protocol development, evaluation, and 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.

Skills

Multiple priorities

Regulated environment

Quality mindset

Financial data analysis

Interpersonal skills

Customer relationships

Education

Bachelor's degree in nursing

1 year of clinical nursing experience

Associate's degree in nursing

LPN with 4 years of clinical nursing experience

Job description

Indiana University, Riley Hospital for Children, seeks a Clinical Research Nurse to support hematology/oncology trials. You will initiate, monitor, and coordinate clinical studies; assist the PI with adverse events; and report data to sponsors.

The role involves regulatory submissions, recruitment planning, specimen handling, and budget review. Requires a nursing degree with clinical experience; IU offers comprehensive benefits and a competitive salary in Indianapolis.