Jerusha Andrews
Chicago,IL
Summary
Clinical Research Professional with 5+ years of experience supporting and monitoring Phase I–III clinical trials across CRO and academic medical center environments. Proven expertise in clinical trial operations, regulatory compliance, and site management with strong knowledge of ICH-GCP, FDA regulations, and IRB processes. Experienced in coordinating complex oncology and infectious disease trials, mentoring research staff, and collaborating with investigators and cross-functional teams to ensure high-quality study execution. Recognized for driving protocol adherence, participant safety, data integrity, and operational efficiency while supporting patient recruitment, regulatory documentation, and audit readiness.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Clinical Research Associate II – Site Management & Clinical Trial Operations
ICON PLC
11.2025 - Current
- Lead site management activities including pre-study, site initiation, routine monitoring, and close-out visits ensuring protocol adherence and data integrity.
- Provide operational guidance and mentorship to site coordinators and research staff on protocol requirements, regulatory compliance, and best practices in clinical trial conduct.
- Review source documents and case report forms (CRFs) to verify data accuracy and compliance with study protocols.
- Generate and resolve EDC queries and track serious adverse events (SAEs) to ensure timely reporting and regulatory compliance.
- Collaborate with investigators, coordinators, vendors, and sponsors to resolve study escalations and maintain continuity of trial operations.
- Support audit readiness through documentation review and participation in sponsor and regulatory inspections.
- Partner with study sites to optimize patient recruitment strategies and support enrollment performance.
- Monitored study progress and data integrity by conducting regular site visits and audits.
Clinical Research Associate I
Fortrea Inc.
07.2023 - 11.2025
- Conducted monitoring visits including site initiation, interim monitoring, and close-out visits across multiple clinical trial sites.
- Ensured compliance with ICH-GCP, FDA regulations, and study protocols while maintaining high-quality clinical data.
- Reviewed source documentation and CRFs to verify protocol compliance and data accuracy.
- Generated and resolved data queries and tracked protocol deviations and safety events in accordance with regulatory timelines.
- Coordinated with investigators and site teams to resolve operational challenges and improve study performance.
- Supported audit preparation and sponsor inspections through comprehensive documentation review.
Associate Clinical Research Coordinator
Rush University Medical Center – Department of Oncology
12.2022 - 07.2023
- Served as lead coordinator for complex oncology clinical trials, overseeing study activities from startup through closeout while ensuring compliance with ICH-GCP, FDA regulations, and institutional SOPs.
- Facilitated disease group meetings with investigators, pharmacists, clinical research nurses, regulatory staff, and laboratory teams to coordinate study activities and resolve operational challenges.
- Managed regulatory documentation including IRB submissions, protocol amendments, safety reports, and essential study files.
- Reviewed and resolved data queries and documented protocol deviations and adverse events while ensuring timely sponsor reporting.
- Mentored research staff and assisted with training on protocol procedures, study documentation, and patient safety requirements.
- Assisted with patient recruitment efforts including eligibility screening, participant education, and coordination of study visits.
Clinical Research Coordinator II
Synexus (PPD, part of Thermo Fisher Scientific)
06.2022 - 12.2022
- Managed daily operations of multiple FDA-regulated clinical trials ensuring compliance with regulatory guidelines and protocol requirements.
- Conducted informed consent, screening, enrollment, randomization, vitals collection, and follow-up visits for study participants.
- Assisted with investigational product administration including injectable and IV infusion therapies while monitoring participant safety.
- Documented adverse events, protocol deviations, and safety reports and ensured timely reporting to investigators and sponsors.
- Maintained regulatory documentation and assisted with sponsor audits and regulatory inspections.
- Provided support and training to research staff on study procedures and compliance requirements.
Research Coordinator
University of Chicago
09.2021 - 09.2022
- Coordinated daily operations for NIH-regulated and investigator-initiated clinical studies.
- Managed participant recruitment, enrollment tracking, and follow-up visits to maintain study timelines.
- Maintained study databases, SOPs, and survey instruments to support accurate data collection and reporting.
- Conducted quality assurance reviews to ensure regulatory compliance and data integrity.
- Assisted with onboarding and training of new research staff.
Clinical Research Coordinator
University of Cincinnati – Department of Emergency Medicine
10.2019 - 09.2021
- Screened and enrolled participants into multiple clinical trials while ensuring informed consent and eligibility requirements were met.
- Served as primary liaison for study participants and coordinated all study-related communication and support.
- Collected and processed biological specimens according to study protocols and shipment regulations.
- Reviewed medical records and source documentation to ensure accurate clinical trial data.
AmeriCorps Addiction Navigator
Mercy Health West Hospital Emergency Department
09.2019 - 08.2020
- Conducted SBIRT screenings to assess patients’ risk for mental health and substance use disorders.
- Partnered with treatment centers and community programs to facilitate patient transitions into inpatient and outpatient care.
- Maintained follow-up contact with patients to provide ongoing support and resource access.
Education
Bachelor of Science - Health Promotion & Education
University of Cincinnati
08-2021
Skills
- Clinical Trial Operations
- Study Start-Up & Close-Out
- ICH-GCP & FDA Regulatory Compliance
- IRB Submissions & Amendments
- Patient Recruitment & Enrollment Support
- CTMS & EDC Systems
- Cross-Functional Team Leadership
- Staff Training & Mentorship
- Sponsor & Investigator Collaboration
- Monitoring & Audit Readiness
- Protocol Implementation
- Data Integrity & Query Resolution
- Site management
Certification
Good Clinical Practice (GCP)
Therapeutic Experience
- Infectious Disease: Vaccines for viral disease prevention– RSV (Phase II, III), Covid19 (Phase II/III, III), Chikungunya Virus (Phase III)
- Oncology: Hematologic Malignancies – Diffuse Large B-Cell Lymphoma (Phase III), Multiple Myeloma (Phase III), non-Hodgkin’s Lymphoma of B Cell Origin (Phase I/II), Acute Myeloid Leukemia (Phase III), Breast Cancer (I,II)
- Oncology: Stem Cell Transplant
- Immune Mediate Inflammatory Disease: Rare disease- Advance Systemic Mastocytosis (Phase II), Non-advance Systemic Mastocytosis (Phase II)
- Ophthalmology: Macular Degeneration-Neovascular age-related macular degeneration (nAMD)
- Other: Behavioral Interventional Clinical Trials: HIV/AIDs, Covid 19
Timeline
Clinical Research Associate II – Site Management & Clinical Trial Operations
ICON PLC
11.2025 - Current
Clinical Research Associate I
Fortrea Inc.
07.2023 - 11.2025
Associate Clinical Research Coordinator
Rush University Medical Center – Department of Oncology
12.2022 - 07.2023
Clinical Research Coordinator II
Synexus (PPD, part of Thermo Fisher Scientific)
06.2022 - 12.2022
Research Coordinator
University of Chicago
09.2021 - 09.2022
Clinical Research Coordinator
University of Cincinnati – Department of Emergency Medicine
10.2019 - 09.2021
AmeriCorps Addiction Navigator
Mercy Health West Hospital Emergency Department
09.2019 - 08.2020
Bachelor of Science - Health Promotion & Education
University of Cincinnati