Lauren McIver
Tipp City,OH
Summary
Dynamic Clinical Operations Specialist with over 5 years of experience in managing clinical trials and ensuring compliance with regulatory standards. Proven expertise in leading teams, executing quality control reviews and developing workflows that enhance operational efficiency. Successfully coordinated multiple Phase II-III trials, enhancing data accuracy and inspection readiness. Committed to leveraging skills to drive quality outcomes and improve patient safety in a Clinical Operations Specialist role.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Patient Data Coordinator, Project Lead
ObjectiveHealth
Remote
08.2024 - 01.2026
- Acted as the operations Point of Contact and Project Lead across multiple Phase II-III trials, facilitating timelines, deliverables and stakeholder communications.
- Coordinated weekly meetings, monitored action items, and ensured follow-through with site leadership, executive stakeholders, sponsors and CROs.
- Formulated and standardized workflows, tracking tools and recruitment processes for consistent application across various projects.
- Oversaw site start-up, ongoing operations, and closure activities, including documentation audits, reconciliation and transfer work.
- Upheld strict compliance with SOPs, GCP and internal quality standards.
Quality Control Specialist
ObjectiveHealth
Remote
09.2023 - 08.2024
- Executed systematic QC reviews of clinical trial data, adverse events, lab reports and source documentation to guarantee regulatory and protocol compliance.
- Identified data quality gaps and collaborated with clinical operations and data teams to resolve queries and discrepancies effectively.
- Enhanced GCP, SOP and internal quality standards, contributing to improved inspection readiness and minimized rework.
- Strengthened data accuracy and consistency across systems, facilitating reliable reporting and downstream submissions.
Advanced Clinical Research Coordinator
ObjectiveHealth
Springboro, OH
10.2021 - 10.2023
- Coordinated Phase II–IV clinical trials across NASH, MASH, cirrhosis, IBD and Crohn's disease, managing activities from start-up to close-out.
- Managed regulatory documentation and eTMF, including FDA 1572s, DOA logs, training records and IRB correspondence.
- Supported and hosted PSSV, SIV, IMV, and monitoring visits, ensuring inspection-ready sites and efficiently addressing follow-up actions.
- Facilitated patient screening, informed consent support, EDC data entry and query resolution to uphold patient safety and data integrity.
Clinical Supervisor
Kettering Health Network
Vandalia, OH
01.2019 - 10.2021
- Provided clinical and operational leadership for a team of 10 or more staff, ensuring quality and compliant patient care.
- Developed and implemented policies, procedures, and workflows in
- alignment with regulatory and organizational standards.
- Directed staff training, performance evaluations, and competency
- development to enhance clinical excellence.
- Collaborated with multidisciplinary teams to optimize operational efficiency, communication and quality outcomes.
Licensed Practical Nurse
Ohio Pediatrics
Vandalia, OH
01.2018 - 04.2019
- Provided direct patient care while accurately documenting clinical information and coordinating care activities.
- Supported physicians and care teams to ensure safe, timely, and compliant patient services.
- Maintained strict adherence to HIPAA, safety protocols, and clinical standards.
- Contributed to enhancing patient flow and operational support within a fast-paced pediatric environment.
Education
Bachelor of Science - Business Administration And Management
Indiana Wesleyan University
Marion11.2027
Associate of Science - Business Administration
Indiana Wesleyan University
Marion, IN12.2022
Associate of Science - Licensed Practical Nursing
Ohio Medical Career College
Dayton08.2017
Skills
- Clinical Trial Operations (Phase II-III)
- Study Start-up & Site Activation
- Operations Point of Contact (POC)
- Multi-Site Trial Support
- Site Engagement & Relationship Management
- Feasibility Assessment & Enrollment Projections
- Study Kick-Off Planning & Execution
- Sponsor & CRO Collaboration
- Regulatory Binder & eTMF Management
- FDA 1572 Management
- IRB/EC Compliance Support
- ICH-GCP Compliance
- Meeting Facilitation & Documentation
- Workflow Standardization
- Site Closure Project Management
- Quality Assurance & Quality Control
- Microsoft Office
- Sharepoint
- Veeva
Certification
- Licensed Practical Nurse (LPN) – State of Ohio
- HIPAA Privacy & Security Training
- Good Clinical Practice (GCP) – CITI
- Human Subjects Protection – CITI
- Quality & Documentation Compliance Training (EDC & Complion Systems)
- OSHA Bloodborne Pathogens Training
Timeline
Patient Data Coordinator, Project Lead
ObjectiveHealth
08.2024 - 01.2026
Quality Control Specialist
ObjectiveHealth
09.2023 - 08.2024
Advanced Clinical Research Coordinator
ObjectiveHealth
10.2021 - 10.2023
Clinical Supervisor
Kettering Health Network
01.2019 - 10.2021
Licensed Practical Nurse
Ohio Pediatrics
01.2018 - 04.2019
Bachelor of Science - Business Administration And Management
Indiana Wesleyan University
Associate of Science - Business Administration
Indiana Wesleyan University
Associate of Science - Licensed Practical Nursing
Ohio Medical Career College