Clinical Research Monitor (Quality Control Specialist

CLINICAL TRANSLAT SCI (CTSI) (IN-DMCT-IUINA)

The Indiana Clinical and Translational Sciences Institute (CTSI) in the Indiana University (IU) School of Medicine seeks qualified candidates for the Clinical Research Monitor role within the Regulatory Knowledge and Support Program. This position serves as the independent clinical research monitor for a portfolio of investigator-initiated clinical trials, particularly studies conducted under Investigational New Drug (IND) applications and Investigational Device Exemptions (IDEs), providing monitoring oversight for studies at IU and collaborating sites through onsite and remote monitoring visits.

The role supports the CTSI's mission to advance high-quality clinical and translational research by promoting regulatory compliance, research quality, and data integrity.

• Conduct independent onsite and remote monitoring visits in accordance with study-specific monitoring plans.
• Verify compliance with study protocols, Monitoring Plans, FDA regulations, ICH-GCP (Good Clinical Practice), Institutional Review Board (IRB) requirements, Indiana University policies, and applicable regulatory standards.
• Review essential regulatory documents, informed consent documentation, source records, investigational product accountability, eligibility determinations, safety reporting, and case report form data.
• Prepare comprehensive monitoring reports, communicate findings to study teams, and document follow-up activities.
• Assess study team needs and recommend strategies to improve study conduct, regulatory compliance, and data quality.
• Provide initial and ongoing training to investigators and research personnel regarding monitoring findings, protocol implementation, regulatory requirements, and GCP expectations.
• Participate in investigator meetings, coordinator meetings, and study management discussions.
• Serve as a subject matter expert and resource for clinical research quality and compliance.
• Develop risk-based Monitoring Plans for assigned studies, including monitoring frequency, source data verification strategy, and escalation procedures.
• Develop, revise, and maintain monitoring standard operating procedures (SOPs), guidance documents, monitoring tools, worksheets, and templates.
• Provide input on protocol implementation, case report forms, and study-specific quality management activities.
• Identify, document, and elevate protocol deviations, data discrepancies, and noncompliance with study protocols, GCP, SOPs, and regulatory requirements.
• Collaborate with investigators, research coordinators, and leadership to develop corrective and preventive action (CAPA) plans.
• Monitor implementation and effectiveness of corrective actions.
• Maintain compliance with all applicable federal and state regulations, Indiana University policies, and departmental procedures.
• Develop, update, and present educational content for the CTSI Clinical Research Staff Education curriculum focused on best practices for source documentation, source data quality, ALCOA+ principles, and regulatory expectations.
• Contribute to educational resources that promote consistent, compliant documentation practices across the clinical research workforce.
• Maintain current knowledge of applicable disease states, investigational products, study protocols, Investigator Brochures, FDA guidance, and evolving regulatory requirements.
• Participate in continuing education to maintain expertise in clinical research monitoring, quality management, and regulatory compliance.
• Partner with investigators, research teams, CTSI leadership, and the Office for Research Compliance to promote research quality initiatives.
• Assist study teams in preparing for internal and external audits by reviewing regulatory documentation and identifying compliance gaps.
• Collaborate with management to prioritize monitoring assignments and support institutional quality improvement initiatives.

• Develop and implement moderately complex project plans consistent with the requirements of current and new federal, state, and local regulations and statutes as well as the compliance policies of the university.
• Manage implemented project plans including maintenance of program documentation, performance of training, monitoring and auditing.
• Collaborate with key research and operational stakeholders at IU to identify research compliance gaps, find solutions to mitigate risks and implement project plans.
• Continuously monitor regulatory changes and determine impact on research community.
• Collaborate with the research community to disseminate information and develop solutions to address regulatory requirements and contribute to compliance decision making.
• Expand knowledge by managing and participating in various committee meetings and attending workshops and conferences.

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…