Clinical Research Coordinator, Pediatric Hematology/Oncology

Overview PED-HEMATOLOGY/ONCOLOGY (IN-PHEM-IUINA). The Department of Pediatrics employs nearly 1,000 faculty and staff who work alongside Riley Hospital for Children and students of Indiana University (IU) School of Medicine to serve 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. Responsibilities Department-Specific Responsibilities Determines and verifies patient eligibility per study requirements and ensures consents are obtained for the clinical trial. Collects and evaluates the study data and submits data reports to sponsors/PI. Ensures compliance with study schedules and data submission. Coordinates and ensures collection and processing of specimens as directed by the clinical trial. Coordinates site visits and monitoring visits with sponsors. Works with financial staff to determine study versus standard of care procedures for study billing compliance. Prepares and documents protocol deviations as required by sponsor and IRB. Prepares study documents, sponsor or regulatory agency audits, or monitoring visits. 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 filing regulatory documents appropriately. Prepares IRB documents (Informed Consent, advertisement, protocol and protocol summary) and 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 stakeholders (healthcare providers, study participants, laboratory personnel, etc.). Reviews incoming subject SAE information, assists PI in determining submission 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/Experience and Certifications 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: SOCRA/ACRP Clinical Research Certification upon date of hire. Skills Demonstrates analytical skills. Ability to simultaneously handle multiple priorities. Possesses strong technical aptitude. Demonstrates a high commitment to quality. Excellent organizational skills. Additional Requirements The role regularly requires the ability to effectively communicate, move about the work environment, operate laboratory equipment, and move objects up to 25 pounds. The role may involve near moving mechanical parts. The person in this role must be able to perform the essential functions with or without accommodation. Location and Compensation Location: Indianapolis, Indiana Salary: $55,000.00 - 65,000.00 annually, based on experience, skill level, education, and training. Benefits (full-time staff) 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 AD&D 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) Note: IU is an equal opportunity employer and provider of ADA services. See IU\'s Notice of Non-Discrimination for details. This posting is scheduled to close at 11:59 pm EST on the advertised close date and may be closed any time at the University\'s discretion, but will remain open for a minimum of 5 business days. #J-18808-Ljbffr