Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
14
14
years of professional experience
Work History
Senior Clinical Research Associate
WuXi Clinical Development, Inc.
11.2022 - Current
Conducting site initiation, monitoring, and closeout visits to verify study procedures, regulatory documents, and data completion
Monitoring patient safety and ensuring adherence to ICH-GCP, SOPs, and study protocols
Ensuring sites maintain accurate and up-to-date regulatory documents, case report forms, and source documents in site binders to ensure compliance and data integrity.
Collaborating with clinical study teams to track site progress, monitor enrollment targets, and support high-quality data entry.
Reviewing participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
Updating CTMS and other relevant systems post-site visits, logging necessary data, including deviations and visit details
Supporting sites in maintaining high-quality data entry by collaborating with data management to identify key focus areas for sites and team members.
Conducting follow-ups on-site visit action items, managing site calls with minutes and updates, and assisting in compiling baseline data for progress reports.
Directing and guiding tasks to teams and developing project schedules, resource requirements, and timelines to maintain productivity on goals and objectives.
RN Case Manager
Three Oaks Hospice
02.2022 - 11.2022
Performed assessment and assistance with care of terminal illness while following the plan of care
Coordinated care with interdisciplinary team, patient/family, and the referring agency
Educated patients/families on healthcare needs, conditions, and changes
Senior Clinical Research Associate | Clinical Research Associate I and II
Premier Research
04.2014 - 01.2022
Led site monitoring activities for oncology, endocrinology, and infectious disease trials
Developed site-specific monitoring tools and tracked study-specific reports
Managed SAE reconciliation, ensuring timely and accurate reporting
Conducted risk-based monitoring and site trend analysis to enhance trial efficiency
Provided co-monitoring support and participated in audit preparation
Research Study Coordinator
Katy Medical
01.2013 - 01.2014
Assisted with patient recruitment, informed consent, and regulatory documentation
Coordinated investigator site files and supported data collection activities
LVN Charge Nurse (Full-time)
St. Dominic's Village Nursing Home
03.2011 - 01.2012
Provided care to patients with post-operative total knee, hip, ankle, bowel, and graft surgeries
Delivered care for residents with various illnesses including Arthritis, CHF, Diabetes, CVA, COPD, Mental Depression, Hypertension, Osteoporosis, Parkinson's, Dialysis, and Dementia
Monitored patient PTT/INR levels to determine the need for anticoagulant therapy and to identify potential side effects of medications
Demonstrated strong observation, assessment, and intervention skills
Experienced with patient transfers and CPM machine operation
Supervised support staff and other therapists effectively
LVN
Courtyard Convalescent Centre
12.2010 - 12.2011
Monitored vital signs, conducted medication passes, and administered Accuchecks and insulin
Provided IM injections, catheterization, and G-tube feeding preparation
Transcribed physician orders accurately
Performed wound treatment and dressing changes as ordered
Supervised support staff and other therapists
Education
Master's - Public Health
Liberty University
Lynchburg, VA
12.2026
Associate Degree - Nursing
Burnette International College
West Palm Beach, FL
Bachelor of Science - Banking and Finance
Nnamdi Azikiwe University
Nigeria
Skills
Clinical trial monitoring
Regulatory compliance
Site initiation, IMV & Closeout visits
Good Clinical Practice (ICH-GCP)
Risk-based monitoring
Site trend analysis
Study-specific training
SAE reconciliation
Audit preparation
Cross-functional collaboration
CTMS and EDC systems
Follow-up on action items &Site support
Data quality management
Progress tracking
Administrative support
Documentation and trial master file (TMF) maintenance
Professional Affiliations And Certifications
Protecting Human Research Participants (PHRP), 11/22 - 11/25
GCP NIDA Clinical Trials Network, 11/22 - 11/25
Therapeutic Experience
Oncology (Solid Tumors, Breast Cancer, Hepatocellular Carcinoma, Lymphoma)
Senior Clinical Research Associate | Clinical Research Associate I and II
Premier Research
04.2014 - 01.2022
Research Study Coordinator
Katy Medical
01.2013 - 01.2014
LVN Charge Nurse (Full-time)
St. Dominic's Village Nursing Home
03.2011 - 01.2012
LVN
Courtyard Convalescent Centre
12.2010 - 12.2011
Associate Degree - Nursing
Burnette International College
Master's - Public Health
Liberty University
Bachelor of Science - Banking and Finance
Nnamdi Azikiwe University
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