Clinical Research Coordinator

Department Information

The Indiana University (IU) Melvin and Bren Simon Comprehensive Cancer Center is the central hub for cancer research and education across Indiana University. It is the state's only National Cancer Institute (NCI) designated Comprehensive Cancer Center and 1 of only 57 in the nation. The comprehensive designation recognizes the center's excellence in basic, clinical, and population research; outstanding educational activities; and effective community outreach across the state.

Job Summary

Department-Specific Responsibilities

• Coordinates day-to-day operations of global oncology research studies conducted in Malawi and Kenya. Serves as a primary liaison between Indiana University School of Medicine investigators and international research partners.
• Develops and maintains study timelines, protocols, and standard operating procedures. Organizes and documents investigator meetings, trainings, and site communications.
• Tracks study milestones and deliverables across multiple sites and time zones. Assists in budgeting, expenditure tracking, and reporting for study-related activities.
• Supports preparation and submission of study protocols, amendments, and continuing reviews to Indiana University Institutional Review Board (IRB) and local/national ethics committees in Malawi and Kenya. Maintains regulatory documentation, approvals, and compliance records. Monitors protocol adherence and assists with internal and external study audits.
• Oversees data collection processes to ensure accuracy, completeness, and timeliness. Coordinates data entry, validation, and quality assurance procedures.
• Collaborates with biostatisticians and investigators on data analysis plans. Conducts basic data analysis using statistical software. Generates summary reports, tables, and figures for presentations, manuscripts, and grant reports.
• Assists investigators with drafting, editing, and formatting scientific manuscripts for peer-reviewed journals. Coordinates co-author contributions, revisions, and submission timelines. Prepares abstracts and posters for national and international conferences. Tracks manuscript progress from submission through publication. Supports dissemination of research findings to international collaborators and stakeholders.
• Assists with identifying funding opportunities related to global oncology and global health research.

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 Principal Investigator (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.