Overview**Please note. This position is not eligible for H1B Sponsorship.POSITION SUMMARY: The Clinical Research Monitor performs monitoring and audit activities across OSF HealthCare's research portfolio to support institutional oversight of active research studies. This role evaluates study conduct, regulatory documentation, and operational readiness to ensure compliance with protocols, regulatory requirements, and institutional policies.
***Hybrid work schedule in Peoria, IL.QualificationsREQUIRED QUALIFICATIONS:Education: Bachelor's degree in healthcare, life sciences, nursing, public health, regulatory science, or related field.
Experience:
- 3 years of experience in clinical research, including roles in clinical trial operations, regulatory coordination, monitoring, or research quality assurance.
- Experience reviewing research documentation for compliance with Good Clinical Practice (GCP), federal regulations, and institutional policies.
- Experience reviewing research documentation including electronic medical records (EMR), regulatory binders, and electronic regulatory systems.
- Experience identifying protocol deviations, documentation deficiencies, and compliance risks in clinical research settings.
- Experience working with investigators, research teams, and clinical staff within a healthcare or clinical research environment.
Other Skills/ Knowledge:
- Excellent interpersonal and communication skills.
- Solid computer skills, including proficiency with Microsoft software.
- Strong analytical and problem-solving skills, with the ability to be detail oriented. Knowledge of Good Clinical Practice (GCP) and federal regulations governing human subjects research.
- Understanding of the clinical research study lifecycle, including study start-up, study conduct, and regulatory documentation management.
- Ability to review research documentation and study activities to assess compliance with protocol requirements and regulatory standards.
- Experience navigating electronic health records and research documentation systems. Strong analytical and investigative skills with attention to detail.
- Ability to prepare clear monitoring reports and documentation of findings.
- Ability to collaborate with investigators and research teams to support continuous quality improvement in research operations.
PREFERRED QUALIFICATIONS:Education: Master's degree in healthcare, life sciences, nursing, public health, regulatory science, or related field.
Experience:
- Clinical trial monitoring experience, such as Clinical Research Associate (CRA), research auditor, or sponsor monitor.
- Experience supporting industry-sponsored clinical trials.
- Experience working in a large health system, academic medical center, or contract research organization (CRO).
- Experience supporting complex or high-risk clinical trials, including oncology or early-phase studies.
- Experience conducting risk-based monitoring, site readiness reviews, or quality assurance assessments.
Licensure/ Certification: Certified Clinical Research Professional (CCRP). Certified Clinical Research Associate (CCRA). Certified Clinical Research Coordinator (CCRC). Regulatory Affairs Certification (RAC). Certified Professional in Healthcare Quality (CPHQ).
Other research, audit, or monitoring certifications not listed.
Other Skills/ Knowledge: General understanding of medical terminology.
- Demonstrated ability to train individuals and provide education to small groups.
- Experience using Clinical Trial Management Systems (CTMS), REDcap, Cosmos, Epic, and/or other research software systems.
