Clinical Research Coordinator, Pediatrics Neonatal-Perinatal Medicine

PED-NEONATAL MEDICINE (IN-PNEO-IUINA)

The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside employees of Riley Hospital for Children and students of IU School of Medicine 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. If you choose to join our team, you can expect a culture that values excellence, respect, integrity, diversity, and cooperation.

The Perinatal Genomics Program was launched in 2021 with the overall goal to improve care for fetuses and newborns impacted by genetic disease. The program has 3 key pillars: clinical care, education, and research. The Perinatal Genomics research program collects, stores, and analyzes genomic and clinical outcomes for patients cared for in the Riley NICU over the first 6 years of a patient's life. All data is stored in a REDCap database. The goal is to better understand how different clinical genomic initiatives impact a patient's care and outcome during early childhood. Current research initiatives of the program are focused on methodologies for rapidly diagnosing genetic disorders, the economic impact of genetic disease, developing and implementing therapeutic clinical trials for a variety of genetic disorders, and implementing a pharmacogenomics program in the NICU.

Department-Specific Responsibilities

• Develops clinical research protocols and manage all IRB documents, submissions, and reviews. 
• Works with appropriate stakeholders to optimize efficiency of data extraction from the EMR and outside genetic testing laboratories. 
• Prepares interval summaries of data collection and analysis. 
• Assists with manuscript preparations.
• Takes ownership of the program and drive its success by developing and implementing strategic plans.
• Collaborates with cross-functional teams to define program objectives, needs, and outcomes.
• Identifies and mitigates risks, ensuring smooth execution of the program.
• Fosters a culture of innovation by encouraging creative thinking and exploring new approaches.
• Monitors program performance and make data-driven decisions to optimize outcomes.
• Acts as a liaison between stakeholders, in both the research and clinical domains, ensuring effective communication and alignment across stakeholders.

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.

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 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. 

Preferred

• Experience managing a research program. 

LICENSES AND CERTIFICATES

Preferred

• SOCRA/ARCP Clinical Research Certification upon date of hire. 

SKILLS

Required

• Demonstrated 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 per 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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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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Indiana University is an equal employment and affirmative action employer and a provider of ADA services. All qualified applicants will receive consideration for employment based on individual qualifications. Indiana University prohibits discrimination based on age, ethnicity, color, race, religion, sex, sexual orientation, gender identity or expression, genetic information, marital status, national origin, disability status or protected veteran status. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator. See Indiana University’s Notice of Non-Discrimination here which includes contact information .

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