Clinical Research Coordinator

Clinical Research Coordinator II — Piedmont Oncology Alliance

Atlanta, GA | January 2023 – Present

• Coordinated clinical trial operations for 6 concurrent Phase II and III oncology trials involving 150+ active participants, ensuring 100% protocol compliance and data integrity.
• Accelerated patient enrollment by 32% over 6 months by developing and deploying digital pre-screening workflows in REDCap, which reduced average screening timelines by 12 days.
• Managed data entry and query resolution for 4 complex trials, reducing average query resolution times by 42% through structured site audits and Medidata Rave validation rules.
• Prepared and submitted 14 protocol amendments and safety reports to the Institutional Review Board (IRB), achieving 100% on-time approvals and zero safety-reporting delays.
• Supervised and trained a team of 3 associate research coordinators, decreasing clinical documentation entry error rates from 8.2% to less than 1.5% over 12 months.

Associate Clinical Research Coordinator — Atlanta Cardiovascular Research Institute

Atlanta, GA | August 2020 – December 2022

• Executed biospecimen tracking and clinical documentation workflows for 4 multi-center Phase II cardiology trials, supporting a cohort of 85 study participants.
• Audited 320 electronic case report forms (eCRFs) in Oracle Clinical, identifying and resolving 94% of data inconsistencies prior to sponsor database lock.
• Orchestrated communications with investigators to report 18 Serious Adverse Events (SAEs) within the mandatory 24-hour window, achieving 100% protocol adherence.
• Streamlined the site regulatory binder upkeep process using Veeva Vault, decreasing audit preparation time by 30% and eliminating document errors across 3 active study protocols.

Clinical trial management, Patient recruitment and screening, Good Clinical Practice (GCP), IRB submissions, FDA regulations (21 CFR Part 11), Electronic Data Capture (EDC), Medidata Rave, REDCap, Veeva Vault, Oracle Clinical, CTMS, Serious Adverse Events (SAE) reporting, Informed consent process, Phlebotomy and sample processing

Decentralized Trial Transition Project

Role: Clinical Trial Lead Coordinator

Tools: REDCap, Veeva Vault, eConsent

Directed the transition of a Phase II oncology trial to a hybrid decentralized format, improving patient retention rates by 24% over 9 months.

Audit Preparation Initiative

Role: Lead Coordinator

Tools: Veeva Vault CTMS, Excel, SharePoint

Led pre-audit documentation remediation of 3 long-term studies, resolving 150+ outdated regulatory documents and achieving zero critical findings during a subsequent FDA audit.

• Certified Clinical Research Professional (CCRP) — Society of Clinical Research Associates (SoCRA) (2022)
• Certified Clinical Research Coordinator (CCRC) — Association of Clinical Research Professionals (ACRP) (2023)
• Good Clinical Practice (GCP) — CITI Program (2020)

• Languages: English (Native), Spanish (Professional working proficiency)
• Volunteer Work: Medical clinic volunteer coordinator at Atlanta Community Health Center (2021-present)
• Availability: Standard 2-week notice period