Calvin Brice
Brooklyn,NY
Summary
Clinical Research Associate with over 8 years of experience in the industry in both pharmaceuticals and medical device, specializing in Oncology.Highly motivated employee with a desire to take on new challenges. Conversational in both Spanish and French
Overview
8
8
years of professional experience
Work History
Senior Clinical Research Associate
Diagnostic Oncology, LLC
09.2022 - 10.2024
- Company Overview: Oncology/Medical Device
- Conducted comprehensive training sessions for investigative site personnel, covering study protocols, data collection procedures, and regulatory compliance
- Monitored 7 clinical study sites, conducted interim monitoring visits and study close out visits, identifying and resolving issues, which enhanced data quality by 20%
- Managed eTMF and eCRF documentation, achieving 95% completeness and accuracy ahead of FDA inspections
- Fostered strong relationships with site personnel and internal team members, enhancing communications and study progress
- Developed, updated, and audited comprehensive monitoring standard operating procedures, including monitoring plans, reports, and corrective/preventive action plans
- Oversaw end-to-end logistics for study material procurement and delivery across 4 study sites
- Oncology/Medical Device
Clinical Research Associate
Parexel
05.2016 - 08.2022
- Company Overview: Oncology
- Facilitated 60 patient enrollments in clinical oncology studies within the first year, exceeding the initial target by 10%
- Implemented a revised patient follow-up system, improving data accuracy and reducing loss-to-follow-up rates by 10%
- Played a key role in shaping the design of protocols, CRFs, and monitoring plans, contributing to improved data integrity and streamlined study execution
- Facilitated pre-study, study initiation, and interim monitoring visits, meticulously adhering to protocol requirements, ensuring data accuracy and integrity throughout the research process
- Evaluated study site staff performance regularly, identifying areas for improvement and providing targeted training interventions which increased performance by 5%
- Conducted onsite and remote monitoring activities for various protocols, ensuring adherence to study timelines and quality standards
- Oncology
Education
Bachelor of Science - Biology
St. Francis College
Brooklyn Heights, New York05.2016
Advanced ICH-GCP Training -
Skills
- Clinical Trial Management
- ICH-GCP Guidelines
- On-Site Monitoring
- Data Collection
- RECIST/iRECIST/irRECIST
- Multilingual
- CTMS - Impact Harmony, Siebel, and Trial Tracker HOT System
- EDC systems (i-Medidata RAVE, Datalabs, OC-RDC, ClinCapture)
- EMR - (NextGen)
- Regulatory Compliance
- Remote Monitoring
- Training
- Microsoft Office
- Trial Design
- FDA Regulations
- eTMF Management
Timeline
Senior Clinical Research Associate
Diagnostic Oncology, LLC
09.2022 - 10.2024
Clinical Research Associate
Parexel
05.2016 - 08.2022
Bachelor of Science - Biology
St. Francis College