Qualifications
REQUIRED QUALIFICATIONS:
Education:
Bachelor’s degree in healthcare, life sciences, nursing, public health, regulatory science, or related field.
Experience:
5 years of experience in clinical research, including roles in clinical trial operations, monitoring, research compliance, or quality assurance.
Demonstrated 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 collaborating with investigators, research teams, and institutional stakeholders 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 quality assurance, auditing, and risk-based monitoring principles within clinical research environments.
Strong knowledge of federal regulations governing human subjects research, including FDA regulations, OHRP requirements, and Good Clinical Practice (GCP).
Understanding of the clinical research study lifecycle, including study start-up, study conduct, and regulatory documentation management.
Ability to evaluate research activities using risk-based monitoring and quality assurance principles.
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 executive-level summaries. Ability to manage multiple priorities and projects in a dynamic research environment.
Ability to collaborate effectively with investigators, research teams, and institutional leaders to support continuous improvement in research quality and compliance.
PREFERRED QUALIFICATIONS:
- Education: Master’s degree in healthcare, life sciences, nursing, public health, regulatory science, or related field.
- Experience: Clinical trial monitoring or auditing experience, such as Clinical Research Associate (CRA), research auditor, or sponsor monitor. Experience supporting complex or high-risk clinical trials, including oncology or early-phase studies.
- Experience working within a large health system, academic medical center, or contract research organization (CRO).
- Experience implementing or supporting risk-based monitoring or quality assurance programs. Leadership or supervisory experience in clinical research operations, compliance, or quality programs.
- 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 with using Clinical Trial Management Systems (CTMS), REDcap, Cosmos, Epic, and/or other.
- OSF HealthCare is an Equal Opportunity Employer.
Qualifications
REQUIRED QUALIFICATIONS:
Education:
Bachelor’s degree in healthcare, life sciences, nursing, public health, regulatory science, or related field.
Experience:
5 years of experience in clinical research, including roles in clinical trial operations, monitoring, research compliance, or quality assurance.
Demonstrated 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 collaborating with investigators, research teams, and institutional stakeholders 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 quality assurance, auditing, and risk-based monitoring principles within clinical research environments.
Strong knowledge of federal regulations governing human subjects research, including FDA regulations, OHRP requirements, and Good Clinical Practice (GCP).
Understanding of the clinical research study lifecycle, including study start-up, study conduct, and regulatory documentation management.
Ability to evaluate research activities using risk-based monitoring and quality assurance principles.
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 executive-level summaries. Ability to manage multiple priorities and projects in a dynamic research environment.
Ability to collaborate effectively with investigators, research teams, and institutional leaders to support continuous improvement in research quality and compliance.
PREFERRED QUALIFICATIONS:
- Education: Master’s degree in healthcare, life sciences, nursing, public health, regulatory science, or related field.
- Experience: Clinical trial monitoring or auditing experience, such as Clinical Research Associate (CRA), research auditor, or sponsor monitor. Experience supporting complex or high-risk clinical trials, including oncology or early-phase studies.
- Experience working within a large health system, academic medical center, or contract research organization (CRO).
- Experience implementing or supporting risk-based monitoring or quality assurance programs. Leadership or supervisory experience in clinical research operations, compliance, or quality programs.
- 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 with using Clinical Trial Management Systems (CTMS), REDcap, Cosmos, Epic, and/or other.
- OSF HealthCare is an Equal Opportunity Employer.
