Customer-Focused Administrative Support Specialist

Christina McLaughlin

North Carolina 910-***-**** *********@*****.*** www.linkedin.com/in/christina-mclaughlin- 6724a6259

Experience

Decentralize Study Manager, Elligo Aug 2025-Mar 2026

• PI Oversight Support & Regulatory Compliance

• Support the Principal Investigator by tracking and maintaining all documentation required to demonstrate PI oversight in line with FDA and GCP standards.

MANAGER, CLINICAL TRIAL DISCLOSURE AND TRANSPARENCY (contract) CSL JUN 2023-DEC 2024

• Forecast demand, manage inventory, and coordinate with various departments to ensure timely procurement and delivery of trial materials.

• Ensured precise redaction of documents to support EC CTR, Clinicaltrials.gov, and publications.

• Maintains clinical trial registry entry/updates, as require

• Coordinating with vendors for the production, labeling, packaging, and distribution of trial material

• Knowledge of regulatory requirements e.g. ICH-GCP 21 CFR Part 11

• Managed a variety of inbound and outbound campaigns and monitored data to calculate the return to the success of the trial ETMF/SENIOR CLINICAL TRIAL ASSOCIATE (contract) REATA JUN 22-MAY 23

• Managing vendors who provide professional development for various CRO and drug companies · Review documents for completeness, accuracy and compliance with GCP standards.

• Collaborate with the Business Admin team to guarantee comprehensive support and consistency in the setup of studies worldwide. Improve and record business system processes for greater efficiency.

• Collect and analyze system data to enhance user workflows and maximize efficiency in resource utilization · Upload and index clinical trial documents into eTMF system

Clinical Trial eTMF Specialist (contract) CHIMEREX AUG 21-JUL 22

• Assist in the creation of study-specific eTMF plans. Create indexes and guide document collection.

• Monitor in IRB audits

• Ensuring adherence to regulatory requirements and quality assurance standards

• Assist and verify the completion of CAPA closure

• Track essential documents and timelines Optimize and record business system processes for greater efficiency.

• Support the site through the Site Evaluation Visit, Site Initiation Visit, greenlight to consent, and Study Closeout

• Manage eTMF & CTMS system, including user access control and systems update

• Generate reports on eTMF & CTMS to identify issues SENIOR CLINICAL TRIAL ASSOCIATE/ETMF (contract) CATALYST FEB 21– JUL 21

• Oversee external vendors and support team to ensure compliance and accuracy including budgets and timelines.

• Ensured precise redaction of documents to support EC CTR, Clinicaltrials.gov, and publications.

• Generate reports and dashboards to track trial progress and key metrics in CTMS

• Create new site and users, change updated information to reflect correct information in CTMS SENIOR CLINICAL TRIAL ASSOCIATE/ETMF (contract) ICON GPHS AUG 20– FEB 21

• Assist CRAs and Regulatory and Start-Up team with accurately updating and maintaining clinical documents and systems into eTMF with the timeline.

• Preform periodic review of study files and completeness.

• Collaborate with the clinical team on the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.

• Support study teams with CTMS training, troubleshooting, and issue resolution

• Manage user roles, permissions, and system access

• Add new site to CTMS with all personnel that will be involved in the study SENIOR CLINICAL TRIAL ASSOCIATE/ETMF-DATA ASSOCIATE COVANCE NOV 18 –JUL 20

• Act as a central contact for the clinical team for designated project communications, correspondence, and associated document Collect, validate, and clean clinical trial data.

• Process payments for clinical and/or medical affairs contractual costs using current processing systems

• Developed and implemented data management procedures for clinical trials, ensuring adherence to protocols and regulations SENIOR Pharmacovigilance SAFETY SPECIALIST PPD JAN 16– NOV 18

• Responsible for monitoring and managing adverse events (AEs) that occur during clinical trials

• Reviewing, evaluating, and reporting individual case safety reports (ICSRs) and aggregate reports (PSURs, DSURs) to regulatory agencies and other stakeholders

• Reviewed safety data, processing adverse events, and ensuring regulatory compliance

• Maintain and update safety databases and related systems within the CTMS, ensuring data integrity

• Record and track adverse events and other safety information within the CTMS

• Collaborate with other members of the clinical team, including the Medical Monitor, and investigators, to facilitate optimal communication and coordination.

PRINCIPAL PROJECT ASSOCIATE PPD JUN 07-DEC 201

• Manage and coordinate cross-functional teams across different departments like data management, biostatistics, regulatory affairs, and clinical monitoring

• Developing and implementing training modules for both new and current users focused on the operational capabilities and optimal practices of the CTMS.

• Grant appropriate user access to the CTMS for site personnel, such as investigators, clinical research associates (CRAs), and auditors, and managing their access levels.

• Create new sites within CTMS through the input of essential information, including site name, address, and contact details. Keeping all information on sites current and acuate.

• Complete site visit reports and upload them to eTMF & CTMS

• Ensure that all necessary documents are collected, maintained, and updated according to Good Clinical Practice (GCP) guidelines and applicable regulations, upload to eTMF & CTMS

• Monitor project budget, identify cost-saving opportunities, and manage financial aspects of the trial. Education

AA. in Business Administration SEP 1999 Central Carolina Community College Skills & Abilities

Siebel Clinical Medidata

CTMS EDC

Phlexglobal Veeva Vault

Oracle Argus

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