Angela Igwe-Simms

Clinical Research Coordinator Ii @Emory Healthcare Winship Cancer Institute

Atlanta, GA, US

Support clinical trial management of multispecialty phase 1 oncology disease groups, protect the rights, safety, and wellbeing of human subjects in clinical trials, manage needs of concurrent, high enrolling trials with detailed knowledge of GCP and ICH guidelines, state and federal regulatory requirements, applicable protocol/sponsor/Emory Winship SOPs, clinical trial process and monitoring procedures. • Coordinate/attend Sponsor, CRO/FDA visits (PSVs, SIVs, IMVs, COVs). • Collaborate with various Principal Investigator (PI) and sponsors to fulfill the requirements of recruiting, screening, enrolling and conducting the follow-up of study participants in clinical trials; Meet enrollment and retention goals, ensure compliance with the study protocol. • Independently manage administrative and oncology protocol project activities including database, regulatory documents, logs, vendors, investigational products/devices, supplies, and equipment. • Collaborate with study management team to deliver quality data and trial documents/records that are compliant with the assigned clinical trial protocol. • Manage subject/participants in sponsor-based clinical trials -recruitment, screening, eligibility, protocol, consents, questionnaires, charges, procedural compliance, scheduling; Dispense investigational product (IP); Lab kit assembly. • Ensure timely trial management and excellent patient safety, care, education, monitoring, query resolution, AE, SAE reporting/communication (PI/IRB/Sponsors/regulatory team/study subjects). • Execute/ensure protocol compliance (delegation, training, certifications); Charting/archiving. • Monitor IRB submissions and responds to requests and questions. • Maintain inspection/audit readiness; Implement corrective and preventive actions (CAPA) to mitigate deviations as necessary; Maintain subject matter expertise (SME); Clinical Trial Document Management and eTMF maintenance.

Gwinnett Technical College

Certified Clinical Research Professional, Clinical Research

Olabisi Onabanjo University, Nigeria West Africa

Bachelor of Science, Business Administration