PED-NEONATAL MEDICINE (IN-PNEO-IUINA)

For more than 90 years, the Department of Pediatrics at Indiana University School of Medicine has provided comprehensive medical training for medical students, residents and fellows in addition to lifelong learning opportunities for practicing physicians. The department consists of 19 specialty divisions based at Riley Hospital for Children at Indiana University Health, which is ranked as one of America’s Best Children’s Hospitals in 10 out of 10 specialties in U.S. News and World Report.

The Division of Neonatal-Perinatal Medicine at Indiana University School of Medicine is one of the leading neonatology programs in the United States, providing neonatology faculty for seven clinical sites in central Indiana, including the Level IV neonatal intensive care unit at Riley Hospital for Children at IU Health in Indianapolis.

Neonatal-Perinatal services at Riley Hospital for Children has been ranked #4 in the nation by Parent’s Magazine for Neonatal-Perinatal care and ranked 14th in the nation by US News and World Report for top hospitals by specialty. This team of specialty pediatricians cares for more than 3,000 patients each year.

Neonatal-Perinatal Medicine at IU School of Medicine continues to grow, offering exciting new opportunities for clinical services, basic and translational research, and innovative educational programs.

Neonatal patients have complex needs and the data obtained from extensive chart review will be used to create quality improvement projects at Riley Hospital and around the nation amongst other Level IV NICUs. The goal of this position will be to improve the care and outcomes for neonatal patients. This role will help collect data from complex neonatal patient charts and utilize this data to benchmark our NICU against other Level IV NICUs across the nation. This data collection will be used to review outcomes and gaps in knowledge. These gaps could also create clinical research studies to ultimately improve patient care, safety, and outcomes.

Department-Specific Responsibilities

• Uses clinical expertise to abstract complex data from NICU patient’s charts, and using this information to guide decisions in how best to document the data into the external databases.
• Reviews patient’s charts in EMR systems.
• Enters clinical information into external databases for Neonatal patients from Riley Hospital: (i.e. CHNC and VON).
• Ensures data integrity by following very detailed MOPs that vary between VON and CHNC.
• Remains professional involvement on focus groups with the CHNC and VON research and quality improvement initiatives.
• Participates in quality improvement projects and quality research projects by attending meetings, collaborating with interdisciplinary team members.
• Enters data for internal quality improvement/quality research projects (using REDCap, excel).
• IRB submissions and amendments, gains knowledge of IRB requirements to participate in quality research studies.

General Responsibilities

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies.
• Participates in study budget negotiations and reconciles study budget accounts.
• Develops informational materials for recruitment of subjects; monitors enrollment goals and modifies recruitment strategy as needed.
• Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary); prepares regulatory documents for sponsor.
• Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews; performs subject interviews and assessments for data required by protocol(s).
• Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.).
• Reviews incoming subject adverse event (SAE) information, assists PI in making submission determination of SAEs, and follows up to determine resolution of adverse events.
• Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply).
• Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators.
• Stays up to date with knowledge of regulatory affairs and/or issues.

EDUCATION / WORK EXPERIENCE

Required

• Bachelor's degree in science or a health-related field and 2 years of clinical research experience; OR
• Associate's degree in science or a health-related field and 3 years of clinical research experience

Combinations of related education and experience may be considered

LICENSES AND CERTIFICATES

Preferred

• SOCRA/ARCP Clinical Research Certification upon date of hire

SKILLS

Required

• Demonstrates analytical skills
• Ability to simultaneously handle multiple priorities
• Possesses strong technical aptitude
• Demonstrates a high commitment to quality
• Excellent organizational skills

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

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

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

• Multiple plan options for medical insurance
• Dental insurance
• Health Savings Account with generous IU contribution
• Life insurance, LTD, and AD&D options
• Base retirement plan contribution from IU, subject to vesting
• Additional supplemental retirement plan options
• Tuition benefit for IU classes
• 10 paid holidays per year
• Generous Paid Time Off
• Paid Parental Leave
• Employee Assistance Program (EAP)

Learn more about our benefits by reviewing our online Benefits Brochure.

Career Level: Career

FLSA: Exempt

Job Function: Research

Job Family: Clinical Research

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Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.

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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New employees will be provided with information regarding Indiana University's COVID-19 vaccine policy, which includes the opportunity to request an exemption. To learn more, view our COVID-19 vaccine information page.

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