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OSF HealthCare

Integrated health system operating hospitals

Manager Clinical Research Monitoring

Medical ResearchUpdated on Nov 11
Full-timePeoria, IL, USA

About the Job

Requirements

  • A bachelor's degree in healthcare, life sciences, nursing, public health, regulatory science, or a related field is required.
  • Five years of experience in clinical research, including clinical trial operations, monitoring, research compliance, or quality assurance, is required.
  • Demonstrated experience reviewing research documentation for compliance with Good Clinical Practice, federal regulations, and institutional policies is required.
  • Experience reviewing research documentation, including electronic medical records, regulatory binders, and electronic regulatory systems, is required.
  • Experience identifying protocol deviations, documentation deficiencies, and compliance risks in clinical research settings is required.
  • Experience collaborating with investigators, research teams, and institutional stakeholders within a healthcare or clinical research environment is required.
  • Excellent interpersonal and communication skills are required, along with solid computer skills, including proficiency with Microsoft software.
  • Strong analytical and problem-solving skills, attention to detail, and knowledge of quality assurance, auditing, and risk-based monitoring principles within clinical research environments are required.
  • Strong knowledge of federal regulations governing human subjects research, including FDA regulations, OHRP requirements, and Good Clinical Practice, is required.
  • Understanding of the clinical research study lifecycle, including study start-up, study conduct, and regulatory documentation management, is required.
  • The ability to evaluate research activities using risk-based monitoring and quality assurance principles is required.
  • Experience navigating electronic health records and research documentation systems is required, along with strong analytical and investigative skills and attention to detail.
  • The ability to prepare clear monitoring reports and executive-level summaries and manage multiple priorities and projects in a dynamic research environment is required.
  • The ability to collaborate effectively with investigators, research teams, and institutional leaders to support continuous improvement in research quality and compliance is required.

Responsibilities

  • Lead the development and implementation of a centralized, risk-based post-approval monitoring program for the research enterprise.
  • Oversee monitoring and audit activities across active research studies, including early-phase and first-in-human clinical trials, to ensure compliance with federal regulations, Good Clinical Practice, institutional policies, and approved study protocols.
  • Partner with Research Administration leadership, investigators, and research teams to identify compliance risks, strengthen research quality, and support the safe and effective conduct of clinical research.
  • Promote a culture of quality, participant safety, and regulatory compliance across the research enterprise.

Desired Qualifications

  • A master's degree in healthcare, life sciences, nursing, public health, regulatory science, or a related field is preferred.
  • Clinical trial monitoring or auditing experience as a Clinical Research Associate, research auditor, or sponsor monitor is preferred.
  • Experience supporting complex or high-risk clinical trials, including oncology or early-phase studies, is preferred.
  • Experience working within a large health system, academic medical center, or contract research organization is preferred.
  • Experience implementing or supporting risk-based monitoring or quality assurance programs is preferred.
  • Leadership or supervisory experience in clinical research operations, compliance, or quality programs is preferred.
  • Certifications such as Certified Clinical Research Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Regulatory Affairs Certification, Certified Professional in Healthcare Quality, or other research, audit, or monitoring certifications are preferred.
  • A general understanding of medical terminology is preferred.
  • The ability to train individuals and provide education to small groups is preferred.
  • Experience using Clinical Trial Management Systems, REDCap, Cosmos, Epic, or other similar systems is preferred.

About the Company

OSF HealthCare

Integrated health system operating hospitals

OSF HealthCare is an integrated health system that runs hospitals, clinics, home health and hospice services, nursing education, and digital health offerings. It operates 18 inpatient facilities with 2,141 beds, including the OSF HealthCare Children’s Hospital of Illinois, and OSF OnCall for remote and hospital-at-home care. The organization also manages nursing schools, charitable activities through OSF HealthCare Foundation, and health-care businesses under Pointcore, while driving innovation and investment via OSF Innovation and OSF Ventures. Its goal is to improve community health by coordinating care across inpatient, outpatient, and digital platforms, while supporting Mission Partners and expanding access to care.

Company size
5,001-10,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Peoria, IL
Founded
1877

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