Summary
Overview
Work History
Education
Skills
Certification
References
Timeline
Generic

Kwannda Whatley

JACKSON,GA

Summary

Dynamic Site Quality Control Manager with extensive experience at CRA Headlands, excelling in regulatory compliance and data quality assurance. Proven ability to enhance clinical trial management through effective communication and team collaboration, ensuring adherence to GCP standards and successful audit outcomes. Committed to maintaining high standards of subject safety and protocol compliance.

Overview

19
19
years of professional experience
1
1
Certification

Work History

Site Quality Control Manager/Unblinded Director

CRA Headlands
Stockbridge, GA
11.2019 - Current
  • Conduct a review of regulatory documents (blinded and unblinded) to ensure all documents are appropriately completed, submitted, and maintained per GCP standards. Including, but not limited to, appropriate protocols, informed consents, training logs, monitoring letters, IRB approvals, and study-related communications.
  • Conduct review of unblinded documents to ensure accuracy of documentation as well as appropriate study product accountability and dispensation.
  • Conduct a review of the IBC (if applicable), ensuring appropriate training and approvals are in place.
  • Conduct review to ensure appropriate licensing, study specific training, GCP training are in place.
  • Conduct routine data quality assurance checks
  • Review data for deviations, errors, omissions, or inconsistencies
  • Ensure study is being conducted according to applicable SOPs
  • Work with research staff and Principal investigator to ensure identified issues are addressed in a timely and appropriate manner
  • Collaborate to develop, review and maintain SOPs as well as CAPA plans as necessary
  • Work with clinic staff to address audit findings from outside auditors(sponsors, CRO, IRB or FDA inspections.)
  • Prepare for/manage quality assurance audits/regulatory inspections and provide all required documentation to auditors.
  • Aid in development and review of site-created template documents and coordinator support tools to ensure protocol compliance and subject safety (harvest logs, accountability logs)
  • Training of new clinical staff blinded and unblinded
  • Review/ensure investigator oversight
  • Training for study specific IP understanding and study overview

Clinical Research Coordinator CCRC/Unblinded CCRC

Clinical Research Atlanta
Stockbridge, GA
11.2006 - 11.2019
  • Serves as blinded and unblinded coordinator.
  • Licensed in the state to prepare and administer vaccines.
  • Recruit, screen, and enroll trial subjects in a multi-specialty practice per protocol-specific requirements.
  • Obtain informed consent.
  • Conduct study visits per protocol.
  • Proper storage, dispensing, and overall accountability for study drug supplies.
  • Complete Case Report Forms and Source Documents accurately, and maintain proper storage.
  • Prepare for monitor, CRO site visits, and site initiations.
  • Ensure that IND safety reports from sponsors are properly submitted to
  • IRB and filed in regulatory binder
  • Collect and package lab specimens per IATA guidelines.
  • Perform phlebotomy and ECG procedures.
  • Responsible for adverse event/SAE reports and notifications.
  • Responsible for adherence to the study protocol.

Education

Associate of Applied Science - Healthcare Management

Ashworth College
Norcross, GA
06-2013

Registered Medical Assistant

Griffin Technical College
Griffin, GA
06-2002

Skills

  • Regulatory compliance and GCP standards
  • Data quality assurance and quality control
  • Clinical trial management and subject recruitment
  • SOP development and training
  • Effective communication and decision-making
  • Team collaboration and support
  • Attention to detail and organizational skills
  • Problem solving and multitasking
  • Clinical trial management
  • Data management
  • Regulatory compliance
  • Team management expertise

Certification

  • ACRP-Certified Clinical Research Coordinator
  • Registered Medical Assistant
  • X-Ray Certified
  • IATA
  • CITI Human Subject Protection
  • CITI Good Clinical Practice
  • Pharmacy Technician
  • Smoking Cessation

References

References available upon request.

Timeline

Site Quality Control Manager/Unblinded Director

CRA Headlands
11.2019 - Current

Clinical Research Coordinator CCRC/Unblinded CCRC

Clinical Research Atlanta
11.2006 - 11.2019

Associate of Applied Science - Healthcare Management

Ashworth College

Registered Medical Assistant

Griffin Technical College

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