Calvin Brice
Playa Del Rey,California
Summary
Senior Clinical Research Associate with over 8 years of experience in the industry in both pharmaceuticals and medical device, specializing in Oncology and Respiratory. Diligent in performing studies aligned with good clinical practices, management, study-specific requirements, training and mentoring of other CRAs and clinical monitoring plans. In depth knowledge of company procedures, regulatory requirements and quality standards.
Overview
8
8
years of professional experience
Work History
Senior Clinical Research Associate
Diagnostic Oncology, LLC(Oncology/Medical Device)
09.2022 - 06.2024
- Conducted comprehensive training sessions for investigative site personnel, covering study protocols, data collection procedures, and regulatory compliance
- Monitored 7 clinical study sites, identifying and resolving issues, which enhanced data quality by 20%
- Managed eTMF 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.
Senior Clinical Research Associate
Parexel(Oncology)
07.2019 - 08.2022
- 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.
Clinical Research Associate I/II
MEDPACE(Oncology and Respiratory)
04.2016 - 07.2019
- Maintained supply inventory used in study procedures, reduced cost by 50% due to cost efficient strategies
- Developed and implemented SOPs to optimize patient recruitment, providing detailed guidelines to site teams on inclusion/exclusion criteria and increased enrollment by 15%
- Mentored and trained clinical team members, providing guidance on evidence-based practices and co-monitoring progress
- Implemented a monitoring system to track study progress, maintaining open lines of communication with clinical sites and service providers
- Conducted onsite and remote monitoring activities for various protocols, ensuring adherence to study timelines and quality standards.
Education
Bachelor of Science in Biology -
St. Francis College
Brooklyn Heights, New York05.2016
Skills
- Clinical Trial Management
- ICH-GCP Guidelines
- Metrics Management
- Research Planning
- Site Monitoring
- Patient Recruitment
- Data Collection
- RECIST/iRECIST/irRECIST measurement criteria for solid tumors CTCAE 40
- CTMS - Impact Harmony, Siebel, and Trial Tracker HOT System)
- EDC systems (i-Medidata RAVE, Datalabs, OC-RDC, ClinCapture)
- EMR - (NextGen)
- Regulatory Compliance
- Leadership
- Communication
Personal Information
Title: Senior Clinical Research Associate | Oncology & Respiratory
Languages
English
Native or Bilingual
Spanish
Limited Working
French
Limited Working
Timeline
Senior Clinical Research Associate
Diagnostic Oncology, LLC(Oncology/Medical Device)
09.2022 - 06.2024
Senior Clinical Research Associate
Parexel(Oncology)
07.2019 - 08.2022
Clinical Research Associate I/II
MEDPACE(Oncology and Respiratory)
04.2016 - 07.2019
Bachelor of Science in Biology -
St. Francis College