Clinical Research Monitor (Quality Control Specialist)

About the role

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.

Department-Specific Responsibilities

• 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.
• 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 escalate 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.
• 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.
• Absorb and prepare 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.

General Responsibilities

• 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.

Education and Experience

• Required: Bachelor's degree (preferably in business, health services, life sciences, or a related field).
• Required: 3 years of relevant work experience in a sponsored research, compliance, healthcare, or clinical setting.
• Preferred: Experience with FDA-regulated (drug and/or device) research as a research coordinator, regulatory coordinator, or project manager.
• Preferred: Experience in an academic research or industry (e.g., pharmaceutical) setting.

Skills

• Demonstrates ability to maintain confidential information.
• Demonstrates analytical skills.
• Excellent organizational skills.
• Proficient written and verbal communication skills.
• Demonstrates excellent judgment and decision making skills.
• Experience in a regulated environment.
• Excellent collaboration and team building skills.
• Maintains composure under pressure.
• Ability to work within tight time frames and meet strict deadlines.

Benefits

This role is eligible for a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs. For full-time staff employees, Indiana University offers a wide array of benefits including:

• 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 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).

Equal Opportunity Employer

Indiana University is an equal opportunity employer and provides ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.