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Professional Summary
USA-Louisiana-Home-Based CRA II
Accomplished Clinical Research Associate with 10 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards. Accomplished Clinical Research Associate with 10 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards. These experiences have culminated in Christina Claire being an integral part of the Biopharmaceutical Acceleration Model (BAM), which is shortening the distance from lab to life.
Skills
Trial methodologies
Database locking
Pre-study visits
Developing study tools
Project Management
Completing regulatory documents
Project monitoring
Employee training
RaveX
VeevaVault
Contribute to TMF Health KPI Tracking
Work History
CRA II, 11/2018 - Current Icon – Charlotte, NC,
Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good
Pharmacoepidemiology Practice (GPP) and protocol compliance
Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to necessary project team and develops action plans
Maintains working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company
SOPs/processes
Verifies process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
Demonstrates diligence in protecting confidentiality of each subject/patient
Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
Conducted clinical trial in accordance with protocol and recorded and monitored progress.
Created and maintained database and records filing system to document data on specimen collection, processing and storage.
Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
Promoted awareness of project-specific quality and performance standards to support documentation, communication and understanding.
Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
CRA II, 03/2018 - 11/2018 Icon – Boston, MA,
Managed on-site evaluations, internal audits and customer surveys.
Used coordination and planning skills to achieve results according to schedule.
Monitors (remote, onsite or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations -
Plans day-to-day activities for monitoring of a clinical study and sets priorities per site - Prepares for and conducts on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites
Takes the initiative to move the project/program forward by reducing backlog and keeping it at a minimum
Monitors with knowledge of quality/scope and budget parameters
Escalates issues and feedback for the team -
Works with the Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during the monitoring phase -
Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
Provides accurate and timely submission of trip reports
Manages query resolution process with sites and Premier Research Data Management
Assists project team with assessing project feasibility and recruitment, as applicable
Maintains project tracking system of subjects and site information as applicable -
Participates in Investigators' Meeting as designated by Project Manager - Manages investigative sites via telephone calls between visits
Ensures adherence to study timeline and budget - Attends meetings as required - Performs additional duties and assignments, as requested
CRA, 04/2014 - 03/2018 Parexel/Pinnacle Genetics – City, STATE,
Participated in the identification of potential investigative sites, conducted pre-study site qualification visits, collected and reviewed site regulatory documents and prepared site reports
Conducted site initiation visits, trained site personnel on client and regulatory requirements for study conduct
Conducted site monitoring visits and followed up to identify significant findings and issues, and ensured all clinical aspects of studies were being carried out in accordance with the study plan
Ensured site adhere to ICH/GCP, FDA, and state and federal guidelines
Reviewed site files and records, Case Report forms and source documents for completeness, accuracy, consistency and compliance
Managed clinical and regulatory aspects of assigned sites to ensure compliance with protocol specification, SOP’s, and applicable regulations and guidelines
Ensured timely and accurately input of study related information
Attended investigators meetings
Identified and addressed routine site issues including protocol deviations and escalated to study lead
Ensured site regulatory binder was current
Ensured the safety of clinical trial subjects
Proactively identified issues which may have interfered with study progress and implemented strategies to resolve issues
Education
Masters: Healthcare Administration, Expected in 07/2021 - American Sentinel University - Aurora, CO GPA: Status -
Bachelor: Psychology, Expected in 12/2008 - University of New Orleans - New Orleans, LA GPA: Status -
Accomplishments
Cardiovascular -
Hypertension -
Myocardial Infarction
Hematology -
Plastic/hypoplastic anemia
Immunology / Inflammatory -
Ankylosing Spondylitis -
Sjogren Syndrome
Infectious Disease -
Infection, Human Immunodeficiency Virus -
Are Disease
Inflammatory Diseases -
Arthritis
Oncology -
Cancer, B Cell Lymphoma -
Breast Cancer,
Diffuse Large B Cell Lymphoma -
Non-Hodgkin's Lymphoma -
Cancer, Thyroid -
Rare
Psychiatry -
Schizophrenia
Quality Assurance
RAVEX
VeevaVault
Certifications
Good Clinical Practice (GCP)
Clinical Trials
Clinical Research
Clinical Monitoring
Clinical Trial Management
System (CTMS)
CRO Management
Pharmaceutical Industry
Oncology
Electronic Data Capture (EDC),
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