Wendy Bigger
Wichita
Summary
Clinical research professional with robust experience in supporting clinical trials, ensuring compliance, and maintaining accurate documentation. Strong focus on team collaboration and achieving results, adaptable to changing needs. Skilled in regulatory requirements, data management, and site coordination. Reliable with excellent organizational skills, contributing to successful project execution.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Clinical Trial Assistant/Consultant
Opthea
10.2024 - Current
- Company Overview: Biotechnology
- Position Overview: Fully Remote
- Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that track site compliance and performance within project timelines
- Assist the clinical team with the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures
- Assist with periodic review of study files for completeness
- Assist CRAs and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information
- Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow
- Act as a central contact for the clinical team for designated project communications, correspondence, and associated documentation
- Support the clinical operations project teams under the supervision of Clinical Trial Managers
- Contact clinical trial sites, vendors, CROs, and partners as needed
- Maintain the Trial Master File (TMF)
- Submit applicable documents to the Trial Master File (TMF)
- Prepare meeting agendas, meeting minutes, and tracking logs
- Track clinical trial progress, including enrollment tracking, status update reports, and other reports as needed for assigned clinical trials
- Assist with the creation and maintenance of documentation for assigned clinical trials to include presentations, pharmacy manuals, regulatory binders, lab manuals, and training materials
- Partner with external vendors for accurate distribution of all clinical trial related materials to clinical trial sites or clinical team members
Clinical Research Coordinator
Lexitas
04.2022 - 03.2024
- Company Overview: Clinical Research Organization (CRO)
- Position Overview: Fully Remote
- Managed multiple aspects of clinical trials, providing timely updates and escalating issues as needed
- Supported amendments, trackers, and site follow-up for smooth study execution
- Developed reports to summarize study progress and status for management
- Provided comprehensive site support during study start-up, ensuring collection and communication of essential documents, supplies, and study information
- Assisted with document collection and tracking (IRB submissions, procurement), supply shipment to sites, and internal/external document review
- Maintained clinical trial master files (TMF/eTMF) and ensured documentation accuracy
- Coordinated study team activities on behalf of study management
- Remote
Clinical Research Department Supervisor
Colorado Eye Consultants/Corneal Consultants of Colorado
05.2020 - 03.2022
- Company Overview: Littleton, CO
- Ensured adherence to research SOPs, GCP guidelines, human subject protection regulations, and study protocols
- Safeguarded data integrity while prioritizing patient rights, safety, and well-being
- Assisted the PI in staff education and training compliance with federal regulations
- Maintained documentation of staff training and qualifications
- Collaborated with PI and sponsors to prepare IRB and regulatory submissions
- Developed study materials (informed consent, CRFs, enrollment logs, drug/device logs)
- Organized study files (regulatory binders, CRFs, source documentation)
- Littleton, CO
Clinical Research Coordinator
Colorado Eye Consultants/Corneal Consultants of Colorado
06.2019 - 05.2020
- Company Overview: Littleton, CO
- Managed research administrative tasks and data entry
- Responded to patient care inquiries via phone calls
- Screened patient charts for study eligibility
- Facilitated communication between physicians, technicians, and patients
- Maintained and managed patient digital profiles and electronic charting systems
- Filed regulatory documents accurately
- Submitted protocols to IRB and FDA
- Tracked, filed, and implemented protocol amendments
- Managed patient reimbursement payments
- Littleton, CO
Agent Assistant – Licensed in Health and Property/Casualty Insurance
American Family Insurance
08.2014 - 05.2018
- Company Overview: Littleton, CO
- Quoted and met with prospective clients
- Assist agent with document completion and filing
- Audit accounts to ensure accuracy
- Research client policy inquiries
- Littleton, CO
Unit Assistant – Licensed Certified Nurse Assistant
Wesley Medical Center
01.2012 - 01.2014
- Company Overview: Wichita, KS
- Monitored and interpreted electrocardiogram rhythms
- Collaborated with Registered Nurses to provide optimal patient care
- Ensured the safety and ethical treatment of patients
- Established effective communication and relationships with all departments
- Wichita, KS
Education
Bachelor of Science - Healthcare Administration and Management
Colorado State University
Skills
- Regulatory compliance
- Clinicaltrialsgov Management
- Patient recruitment and screening
- Data management
- Auditing
- Organizational skills
- Time management
- Prioritization
- Multi-tasking
- Attention to detail
- Customer service skills
- Written communication
- Verbal communication
- Cross-functional facilitation
- Stakeholder collaboration
- Electronic data capture
- Informed consent process
- Regulatory submissions
- Adverse event reporting
- Clinical research ethics
- Standard operating procedures
- Clinical trial management
- Patient recruitment
- Site selection
- Study coordination
- Clinical operations
- IRB and IEC submissions
- Good clinical practice
- Subject confidentiality
- Willingness to learn
- Teamwork and collaboration
- Problem-solving
- Excellent communication
- Critical thinking
- Reliability
- Patient care
- Adaptability and flexibility
- Decision-making
- Electronic health records
- Medical terminology
Certification
Good Clinical Practice, CITI, 10/24/27
Timeline
Clinical Trial Assistant/Consultant
Opthea
10.2024 - Current
Clinical Research Coordinator
Lexitas
04.2022 - 03.2024
Clinical Research Department Supervisor
Colorado Eye Consultants/Corneal Consultants of Colorado
05.2020 - 03.2022
Clinical Research Coordinator
Colorado Eye Consultants/Corneal Consultants of Colorado
06.2019 - 05.2020
Agent Assistant – Licensed in Health and Property/Casualty Insurance
American Family Insurance
08.2014 - 05.2018
Unit Assistant – Licensed Certified Nurse Assistant
Wesley Medical Center
01.2012 - 01.2014
Bachelor of Science - Healthcare Administration and Management
Colorado State University
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