Summary
Work History
Education
Skills
Timeline
Generic

Patricia Bvumbe

Franklinton,NC

Summary

Detail-oriented clinical trials coordinator with 10+ years overseeing trial operations and regulatory requirements. Coordinate cross-functional activities to support execution, documentation, and compliance. Enhanced productivity through improved tracking infrastructure and comprehensive staff training.

Work History

Clinical Trials Coordinator

BioMerieux
Durham, North Carolina
2012 - 2022
  • Coordinated clinical trial activities to ensure compliance with regulatory guidelines and maintain trial integrity.
  • Facilitated communication among sponsors, CROs, sites, and internal departments to streamline trial progress and address issues promptly.
  • Developed tracking systems for patient enrollment, screening, and randomization to enhance monitoring and reporting efficiency.
  • Facilitated staff training sessions on protocol compliance and best practices.
  • Assisted in developing training materials for clinical research personnel.
  • Executed data entry across multiple electronic systems to maintain accurate records.

Clinical Research Coordinator

Celgene Corporation
Philadelphia, Pennsylvania
2009 - 2011
  • Managed essential documents for the Trial Master File, ensuring compliance and readiness for audits.
  • Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events.
  • Supported project managers and clinical study teams in executing clinical trial activities, ensuring smooth operations.
  • Collaborated with global project team to deliver timely study updates, enhancing communication and project alignment.
  • Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel throughout the clinical trial.
  • Provide support for the planning, preparation, and on-site support of investigator meetings.

Clinical Trial Assistant

EMD Pharmaceutical
Durham, NC
  • Facilitated successful execution of clinical trials by managing research associates for protocol compliance.
  • Trained new staff on clinical trial procedures and provided ongoing support for professional growth.
  • Conducted site visits for monitoring study progress, assessing adherence to protocols, and reviewing documentation.
  • Organized workshops for research assistants to enhance understanding of regulatory document requirements.
  • Collaborated with cross-functional teams to optimize trial processes and maintain clear communication channels.
  • Ensured timely completion of essential documents by investigators while tracking subject enrollment metrics.
  • Managed inventory of study materials and coordinated shipments between sponsors, investigators, and vendors.
  • Prepared submissions for institutional review board approvals, including amendments and renewals.
  • Prepared submissions for Institutional Review Board or Ethics Committee approval, amendments, renewals.
  • Collaborated with internal teams on project timelines and deliverables.
  • Ensured timely completion of essential documents by investigators and research staff.
  • Reviewed patient records to ensure accuracy and completeness according to protocol requirements.
  • Conducted site visits to monitor study progress, assess compliance with protocol, and review source documentation.
  • Maintained regulatory documents such as informed consent forms and investigator brochures.
  • Participated in Investigator Meetings to discuss study updates and issues.
  • Tracked subject enrollment status, screening results, adverse events, concomitant medications.
  • Monitored drug supplies at investigative sites to ensure adequate supply throughout the duration of the trial.
  • Educated participants on studies and anticipated outcomes.

Education

Secretarial Science Degree - Business Administration

Miller-Motte Business College
Wilmington, NC

Training and development conducted by Biomerieux - GCP Workshops, SOP Training, Global Training

Biomerieux
Durham, NC

Skills

  • Clinical trial management
  • Good clinical practice
  • IRB submissions
  • Informed consent
  • Audit preparation
  • Site monitoring
  • Subject confidentiality
  • Study documentation
  • Adverse event reporting
  • Clinical data management
  • Investigational product management
  • Investigational product handling
  • Study coordination
  • Project coordination
  • Training development
  • Clinical training facilitation
  • Document management
  • Master file organization
  • Attention to detail
  • Time management
  • Auditing techniques
  • Research sops understanding
  • Cross-functional collaboration
  • Team leadership
  • Team collaboration
  • Effective communication
  • Interpersonal communication
  • Problem-solving
  • Quality assurance
  • Study closeout
  • Record keeping
  • Subject confidentiality
  • IEC submissions
  • Documentation review
  • Documentation review
  • Quality assurance
  • Clinical operations

Timeline

Clinical Trials Coordinator

BioMerieux
2012 - 2022

Clinical Research Coordinator

Celgene Corporation
2009 - 2011

Clinical Trial Assistant

EMD Pharmaceutical

Secretarial Science Degree - Business Administration

Miller-Motte Business College

Training and development conducted by Biomerieux - GCP Workshops, SOP Training, Global Training

Biomerieux

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Patricia Bvumbe