Pediatric Hematology/Oncology (Clinical Research Nurse)

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

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.

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.

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

• 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

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

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.

Indianapolis, Indiana

$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)

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

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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