Shameca Welch
Study Activation Manager, Global Operations, Iro @Wellstar Health System
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WORK HISTORY
Study Activation Manager, Global Operations, Iro @Wellstar Health System
Led global study start-up and site activation for multi-protocol Phase I–IV clinical trials across a decentralized research networkOversaw site feasibility, regulatory document collection, essential document review, and greenlight-to-consent approvals Partnered with sponsors, CROs, regulatory teams, and site leadership to ensure timely site activation within study timelines and budgets Drove cross-functional study start-up strategy, mitigating risks related to contracts, regulatory delays, and site readiness Served as primary escalation point for start-up barriers, ensuring rapid resolution to prevent enrollment delays Reviewed and approved informed consent forms (ICFs), regulatory packets, and site essential documents Tracked and reported start-up KPIs, cycle times, and activation metrics to senior leadership and sponsorsSupported site readiness for monitoring visits, SIVs, and auditsEnsured compliance with ICH-GCP, FDA regulations, SOPs, and sponsor requirements Accelerated site activation timelines by identifying process gaps and implementing workflow improvements Maintained high quality and inspection readiness across all activated sites Strengthened sponsor relationships through proactive communication and transparent start-up reporting
EDUCATION
Gadsden State Community College
Associate of Science (A.S.), Medical Assistant
Alabama State University
Bachelor of Science - BS, Health Information Management/Medical Records Administration/Administrator
SKILLS
ABOUT SHAMECA WELCH
Clinical research professional with over 8 years of experience supporting Phase I–IV clinical trials across site operations, study start-up, regulatory coordination, and cross-functional trial delivery. I have led global site activation efforts, supported regulatory compliance, and partnered with sponsors and CROs to ensure studies launch on time and operate within quality and performance standards.My background includes site feasibility, essential document review, ICF review, vendor coordination, and study metrics tracking. I have worked across decentralized and traditional trial models and thrive in fast-paced environments requiring strong communication, risk mitigation, and operational leadership.I am currently pursuing opportunities as a Clinical Research Associate (CRA) and Clinical Trial Manager (CTM) where I can contribute to high-quality trial execution, site performance, and patient-centered research delivery.
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