Kimberly Ann Light
Research Associate
Wilmington,NC
Summary
Energetic individual with more than 5 years experience in Clinical Research supporting clinical studies for all Phases I-IV. Managed clinical trials ensuring adherence to FDA Regulations and GCP. Collaborated with cross functional teams leading to improved processes for clinical trial management.
Overview
7
7
years of professional experience
Work History
Client Services Coordinator
Advarra
Columbia, Maryland
10.2024 - 02.2025
- Served as the main Sponsor, CRO and PI site contact on assigned submissions
- Conduct Administrative review of Protocol/Site submissions by reviewing and understand protocol requirements on all supporting documentation
- Demonstrated advanced understanding of multiple types of Protocol and Site Submissions
- Documented and execute client customizations as requested; process change requests for approved protocols
- Managed vendor relations and documentation for foreign language translations
- Maintained a high level of accuracy and attention to details; collaborate with the quality assurance team to ensure minimal rate of error
- Completed work in a timely manner, responding to customers within 24 hours of email/voicemail receipt
- Escalated any customer or timeline issues to management
In-House CRA Site Management Associate
Fortrea
Durham , North Carolina
02.2022 - 05.2024
- Acted as primary contact and supported CRAs in managing site activities such as recruitment, enrollment, query resolution, Regulatory document collection, data collection study supplies and IP
- Supported CRA with remote/onsite monitoring activities; followed up on items from previous visits
- Maintained regular site contact via phone and email and documented those contacts in a defined study system (CTMS)
- Interacted with sites, clients, vendors and study team members
- Prepared and tracked greenlight packages for review
- Maintained GCP and Protection of Human Subjects certification(s)
- Proficient with clinical research documents their documents and purpose
- Managed Study tracking tools to monitor study progress
- Assisted with setting up Study Sites ensuring clinical supplies are on site and staff was trained on the Study Protocol, Regulatory Compliant and GCP trained
- Prepared Investigator Site Files (electronic, paper) for sites and arranged shipping via vendor
- Set up and revocation of access to study systems including EDC, IVRS
- Labs
- Clario, Sharepoint, CTMS and Veeva Vault, Mailboxes
- Coordinated and maintained clinical study documentation in the eTMF including the tracking of documents, preparation of internal, external audits, conducted routine QC reviews, and final reconciliation
- Collected, reviewed and close out of required critical documents from sites utilizing study-specific trial management files, tools and systems
- Collected and reviewed all site level documents during the lifecycle of the study
- Risk Issue Management (Sites) entered identified risks and issues into system for followup and resolution
- Managed IRB Submissions for all phases of the study
- Supported the review of study data in accordance with the Monitoring plan, Data Management Plan to identify data trends, data inconsistencies or missing and incomplete data
- Improved overall turnaround time for query resolution
- Assisted in the preparation of study and site specific materials in accordance with relevant SOPs
- Track and maintenance of key project indicators to meet Sponsor metrics -Study tracking in CTMS and updating milestones to include IRB Submissions, Approvals, Site activation, FSFV and LSLV, etc
- Worked within LMS (Learning Management System) to assign trainings to study staff
- Assisted in the review and approval of essential documents for site activation and release of IP (see additional site start up activities below)
- Assisted with identifying and evaluating sites for study participation
- Conducted site outreach for Clinical Studies
- Initiated CDAs between Sponsors and Institutions that governed access and use of confidential information to include the study protocol and other proprietary information
- Collected and reviewed essential documents
- Checked Debarment List for potential Primary Investigators
Senior Clinical Trial Administrator
Labcorp
Wilmington , North Carolina
01.2019 - 02.2022
- Documented and tracked all study activities using relevant forms and tools as well as relevant Project Management Systems with minimal guidance and support
- Completed minute taking and documentation for Sponsor external or internal teleconferences as requested
- Maintained Trial Master File documentation within the appropriate TMF platform, participated in TMF QC, Reviews, tracked and archived as applicable
- Maintained trackers for IP shipment and delivery; helped to manage inventory at sites, Study Supplies and ISF Binders
- Managed Study Contacts in CTMS; updated milestones
- Developed and provided department Training and Guidance for CTAs
Research Associate
University of North Carolina
Chapel Hill , North Carolina
04.2018 - 10.2018
- Screened and enrolled Subjects for Behavioral Research
- Obtained Informed Consent from study participants
- Assisted in ICF Development and the development of Research Questionnaires
Education
Bachelor of Science - Clinical Research
University of North Carolina
Wilmington, NC 07.2025 - 07.2025
Skills
Customer service focus
Multitasking proficiency
Strong organization
Client relationship building
Therapeutic Experience
- Immune Mediated Inflammatory Disease (IMID): System IMID - Gout (Phase IV)
- CardioMetabolic: Cardiovascular Disease - Acute Coronary Syndrome (ACS) Phase III
- Oncology: Solid Tumors - Breast HER2+ Phase II
- Colon Cancer Study - Prospective Multi-Center Cancer Screening Study
- Device: Device Diagnostic Imaging Contrast Agents (Phase IIa, IV Interventional)
Timeline
Bachelor of Science - Clinical Research
University of North Carolina
07.2025 - 07.2025
Client Services Coordinator
Advarra
10.2024 - 02.2025
In-House CRA Site Management Associate
Fortrea
02.2022 - 05.2024
Senior Clinical Trial Administrator
Labcorp
01.2019 - 02.2022
Research Associate
University of North Carolina
04.2018 - 10.2018
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