Clinical Research Coordinator, Pediatric Hematology/Oncology

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/principal investigators (PI).
• Ensures compliance with study schedules and data submission.
• Captures and processes 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.

General Responsibilities

• 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.

Qualifications

• 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.

Skills

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

Benefits

• 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 IUV.
• 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.
• Generous paid time off plans.
• Paid leave for new parents and IU-sponsored volunteer events.
• Employee assistance program (EAP).