Debbie Langston
Valdese,NC
Summary
In House CRA3 with over 10 years of extensive expertise in Clinical Trial Management, Project Management and Pharmacovigilance adapting at ensuring compliance with ICH/GCP guidelines and regulatory requirements. Demonstrates strong problem-solving and management skills. Proven track record in enhancing project efficiency through detailed document review and effective collaboration with stakeholders, aiming to contribute to innovative research environments.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator II
AON
Asheville
05.2024 - Current
- Coordinated clinical trials at AON, ensuring protocol adherence and data integrity
- Streamlined processes, leading to faster study completion and improved patient outcomes
- Managed participant recruitment and retention strategies, surpassing enrollment targets
- Implemented innovative follow-up methods, reducing dropout rates substantially
- Fostered strong relationships with investigators, sponsors, and regulatory bodies
- Facilitated seamless communication, enhancing study efficiency and compliance
- Meticulously maintained study documentation and regulatory files
- Conducted thorough quality checks, ensuring data accuracy and minimizing protocol deviations
- Pioneered digital data collection methods, significantly reducing processing time
- Developed training programs for staff, improving overall team performance and study quality
- Analyze clinical trial data, ensuring protocol adherence and data integrity
- Implement streamlined processes for faster study completion and enhanced patient outcomes
- Build strong relationships with investigators, sponsors, and regulatory bodies
- Facilitate effective communication for improved study efficiency and compliance
In House CRA3
ICON
10.2022 - 08.2023
- Provided services to, as a CQM Associate
- Utilized the Clinical Trial Management (CTMS) to ensure investigator requirement activities were accurately tracked
- Performed study tracking via the CTMS or Sponsor designated systems to ensure study files were current, accurate, and complete
- Performed essential document collection, reviewed, maintenance, and closed out activities, ensuring that Sponsor and investigator obligations were being met and were in compliance with applicable local regulatory requirements and ICH/GCP guidelines
- Ensured that all tasks meet Sponsor and ICON expectations and were delivered in accordance with the contract, trial protocol, ICH/GCP and applicable SOPs
- Liaised with investigators
- Distributed Compliance Reports
- Performed QC of documents and participated with project team members regarding sites
- Assisted in vendor oversight
- Distributed SUSAR reports in revisions
- Entered RGL's into Safety vigilance
- Contacted sites
Project Specialist II
Clinipace
07.2021 - 10.2022
- Worked alongside with the Project Manager, or equivalent, to provide expertise and coordination to ensure the delivery of the contracted tasks and responsibilities, as outlined in the project's scope of work and contract
- Owned system access administration (system access, ongoing access surveillance, and access revocation)
- Supported the PM/PD with set up and maintenance of the MSP study timeline and reporting timelines to the team
- Supported the PM/PD with creation of study projections (site feasibility, selection, activation, patient enrolment, etc.), as required
- Created and deployed study specific training matrix and ensured team compliance with assigned trainings, including proper documentation and escalation of non-compliance
- Coordinated and provided support with creating the Executive Monthly Report and obtained and maintained study progress reports and trackers
- Reviewed the analytics and reports from Clarity Insight to identify any trends, missing data, and follow-up actions
- Maintained project server and portal where applicable
- Organized and was actively involved in the Kickoff Meetings for the internal and sponsor study teams
- Supported project team and departmental meetings, coordinating the creation of agendas and taking minutes, decision and/or action items for the study sponsor and internal meetings
- Organized/finalized meeting materials for presentations (e.g
- Investigator meetings, internal and client meetings, departmental meetings, etc.)
- Ensured all outstanding actions as discussed in project meetings were tracked until completion
- Coordinated cross functional financial units and milestones reporting
- Supported site payments and associated tracking, as needed
- Worked with Grants Administration to process investigator/site payments and draft amended site budget templates
- Data query, interpersonal with sites, and timelines and entered data into systems
Pharmacovigilance Administrator
Worldwide Clinical Trials
05.2018 - 04.2021
- Closely and provide ad-hoc support for all team members of the Pharmacovigilance related projects as needed; update management on status of projects
- Ensure any unassigned emails in the mailbox are flagged as appropriate
- Prepare all outgoing mail for collection with preparation updates to global and/or study specific templates and documents
- Preparation and submission of documents to the trial master file of departmental and study trackers
- Handle confidential sensitive matters with discretion
- Trained and Mentored New Employees
HR and Office Manager
Park Construction
08.2017 - 05.2018
- Maintained up-to-date billing system
- Followed up on, collected and allocated payments
- Carried out billing, collection and reporting activities according to specific deadlines
- Maintained accounts receivable, customer files and records
- Researched and resolved payment discrepancies
- Reviewed AR aging to ensure compliance
- Prepared bank deposits
- Assisted with month-end closing
- Communicated with customers via phone, email, mail or personally
- Allocated human resources, ensuring appropriate matches between personnel
- Served as a link between management and employees by handling questions, interpreting, and administering contracts and helping resolve work-related problems
Clinical Research Coordinator
Asheville Clinical Research
Asheville , NC
02.2026 - Current
- Gathered, processed, and shipped lab specimens.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Followed informed consent processes and maintained records.
Product Safety Administrator II
PPD
05.2003 - 03.2017
- Provided customer service to client customers who included consumers, health care professionals, and certain client personnel
- Performed administrative functions associated with program operations
- Researched and responded to inquiries
- Created and maintained documentation according to SOPs, protocols, FDA GCPs and regulations
- Identified, recorded adverse events and product complaints
- Maintained project schedule, trained new employees, and coordinated Peer Review Program
- Medical and safety coverage, medical monitoring, medical consulting, regulatory report generation, data monitoring coordination (DMC), MedDRA coding, and remote data entry
- Provided HCP's and Consumers Medical Information and patient assistance programs
- Preapproved documents to speak on behalf
- Triaged callers to appropriate teams for AE reporting
- Provided patients with clinical trial information and studies that were available
- Referred patient to their physicians for clinical studies
- Provided HCP's and Consumers Medical Information
- Created and Maintained Peer Review Program
- Pulled calls for team members to evaluate for possible Adverse Events and Product Complaints
- Trained new team members
- Instructed patients on how to use their medication
- Documented AE's and PC's that were reported in database after each call
- Wrote narratives for Adverse Events and Non-Events
- Team member of PPD social community
- Entered Adverse Events into safety database
- Tasks including meeting organization, filing, photocopying, and updating systems with project allocation
- Submitted literature and medical letters to Physician's office and Patients
- 10 years of Call Center Experience
Optometric Technician
Eye Care Associates
07.2001 - 04.2002
- Assisted in testing patient's and client's vision, providing frame styling services, instructed patients on contact handling, ordered prescribed lenses, provided patients with instructions on the handling of different types of contacts and spectacle lenses
- Scheduled patient's for follow up appointments
- Volunteered and worked at the Carolina Hurricane games, for clients and for school events
- Attended Sales Seminars for Eye Care Associate
Education
Pharmacy Technician Program -
Nash Community College
01.1994
Skills
- ARISG
- CITRIX
- PRIMO
- MICROMEDEX
- AERS
- ARGUS
- RightFax
- ETMF
- Baroclinic
- LMS
- Global Learn
- Safety vigilance
- Veeva Vault
- CTMS
- Sharefile
- Excel
- Microsoft Word
- Scanning
- Administration
- FedEx
- UPS Management
- Coordination
- Complex Problem Solving
- Time Management
- Clerical Support
- Analytical Thinking
- Critical Thinking
- Attention to Detail
- Research
- Flexibility
- Adaptability
- Problem Resolution
- Organization
- Reliability
- Trustworthiness
- Recordkeeping
- Customer Service
- Cultural Awareness
- Relationship Building
- Active Listening
- Decision-Making
- Communication
- Problem Solving
- Regulatory Compliance
- Project Reporting
- Document Control
- Site Liaison
- Financial Tracking
- Meeting Facilitation
- Data Entry
Certification
Medical Information and Clinical Research Certification
Achievements And Awards
- Certificate of Excellence for Perfect Documentation
- Certificate for Achieving Fulfillment as a Team for the Year
- Certificate for Outstanding Employee
Timeline
Clinical Research Coordinator
Asheville Clinical Research
02.2026 - Current
Clinical Research Coordinator II
AON
05.2024 - Current
In House CRA3
ICON
10.2022 - 08.2023
Project Specialist II
Clinipace
07.2021 - 10.2022
Pharmacovigilance Administrator
Worldwide Clinical Trials
05.2018 - 04.2021
HR and Office Manager
Park Construction
08.2017 - 05.2018
Product Safety Administrator II
PPD
05.2003 - 03.2017
Optometric Technician
Eye Care Associates
07.2001 - 04.2002
Pharmacy Technician Program -
Nash Community College