Knowledgeable Research Professional with experience in applying clinical research regulatory requirements SOPs, ICH GCP E6 (R2), FDA, state regulations, and institutional policies IRB Submission Document, Regulatory Approval. Experienced in monitoring multiple studies globally, host and attend cross-functional meetings. Prepared meeting agendas and meeting minutes to upload in eTMF, maintain and comply with action and decision logs, and eClinical. Maintain inspection-ready Train Master File. Review and Create Documents for eTMF filing, verified eTMF INDEX verification code to upload documents to template in eTMF, update SPO Site, QC Reports, Track Personal Metrics, Collaborate with SMA Advocate assigned to study, update LMS training for new members, update ALMAC Track, Track CAP Reports for Team, Update KSIF for new members; I’m self-motivated and adaptable with ability to collaborate in a fast-paced environment with global cross-functional teams. Detail-oriented team player with focus on attention to detail, excellent written and verbal communication, time management, persuasion, problem-solving, decision making, and organizational skills. Proficient with various computer applications such as Word, Excel, and PowerPoint Clinical Research Professional, maximizing and sharing knowledge that improves the care of patients. Focusing on the patients in need, while accelerating patient enrollment and seamlessly capturing data with in-depth tracking of the patient therapeutic experiences. Continuing to press forward with data management while maintaining ICH-GCP regulatory compliance. Ensuring overall operational effectiveness. Auditing of essentials documents in eTMF audits and Informed Consent; electronic documentation in the exchange systems, eTMF and internal tracking systems. Maintaining leadership and training experiences, with excellent written/oral communication skills. While executing clinical research terminology. Achieving laboratory analysis, EKG, phlebotomy, retrieving accurate blood pressure readings and having computer literacy, with proficiency in MS Office applications. Proficient with excellent customer service skills and having a plethora of experience in research and development in oncology and infectious diseases from Glaxo Smith Kline and Duke University.
Listed skills include Good Clinical Practice, Oncology, Data Management, and Patient Recruitment.