Clinical Research Coordinator, Pediatric Hematology​/Oncology

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 (IU) 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.

• 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/principal investigators (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 institutional review board (IRB). Prepares study documents, sponsor or regulatory agency audits, or monitoring visits.

• Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies. Recognizes situations requiring prompt escalation and demonstrates actions to minimize risks.
• Conducts study visit activities and coordinates screening, consenting, and scheduling of tests, exams, and/or non-medical/behavioral interventions and assessments involving study subjects.
• Facilitates and performs various study activities including site evaluation visits, study related meetings and training sessions, study initiation visits (SIV) and monitoring visits.
• Manages all follow-up activities with subjects based on protocols and oversees proper documentation at study close-out.
• 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.
• Ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately; prepares and submits 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.

• Bachelor's degree in science or a health-related field and 1 year of clinical research experience; OR
• Associate's degree in science or a health-related field and 2 years of clinical research experience.

• Society of Clinical Research Associates (SOCRA) / Association of Clinical Research Professionals (ACRP) clinical research certification upon date of hire.

• 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…