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Online Resumes with "Clinical Trial Assistant"
SUMMARY OF EXPERIENCE: CRA Experienced CRA with more than 15 years in clinical trials and extensive experience in management of phase II to IV clinical drug trials to include a device trial. Five years as a Study Coordinator in a Cardiology Research Clinic. Together with medical background as a Registered Nurse possess far-reaching knowledge spanning several therapeutic areas including Cardiovascular, Oncology, Neurology, M...
I want to pursue a position Clinical Research that concentrates in the area of Regulatory Affairs.
Enthusiastic health care professional with extensive experience in clinical trials and sound medical background Seeking a challenging and responsible position as a Global Clinical Trial Research Assistant where I can contribute my knowledge and experience in a health care organization.
Professional Summary: * Certified clinical research professional with nearly 10 years of clinical research experience in the medical device industry. I have a wide range of knowledge with site and study management having worked as an In-house/Field CRA, Lead CRA and Clinical Trial Assistant. * Conducting: Qualification, Initiation and Close-Out monitoring visits for pre and post-market trials. * Start-up activities for both...
PROFILE: Extensive experience in a clinical lab environment with expertise as a Lab Manager and Medical Technologist with skills in operative, clinical trials, quality control, policy and procedures development, accreditation and standardization of lab protocols. AREAS OF EXPERTISE Laboratory Management * Managed a professional staff with oversight for all specimen analysis and reporting. * Oversaw and controlled an operati...
Summary: * Extensive experience in clinical data management, pharmaceutical, and device research industries. * Experience working with Adverse Event Reporting and Medical Device Reporting. * Strong analytical, problem resolution, and project management skills. * Proficient in monitoring and managing record retention timelines for all clinical and regulatory documents and assistance in the preparation and review of documents...
ACCOMPLISHMENTS * Coordinated and conducted clinical and academic research * Coordinated and actively participated in teaching clinical pharmacology course to Internal Medicine staff * Developed a clinical module for pharmacy staff * Developed automatic substitution protocols, resulting in significant dollar savings, reducing length of stay and minimizing bacterial resistance * Established cost-effective formulary * Assesse...
I am currently exploring new opportunities where I can utilize my more than 20 years of experience to add value to the clinical research industry. My experience includes 8.5 years as a Clinical Trial Assistant, 4 years as an In-House CRA, 1.5 years as a Regional CRA, and 5 years supporting study start-up and site activation. I enjoyed managing regional clinical sites the most and want to further my career and skills in this...
Tags for this Online Resume: Protocol, Management, Documentation, Data Entry, Clinical Research, Compliance, Document Review, Research, Query resolution, Inform Consent Form, eCRF guidelines, SAE Reporting, AE Reporting, IRB Submissions, Regulatory Compliance, ICH / GCP / FDA guidelines, Database lock timelines met, Site deficiencies resloved, Patient enrollment and retention, Ongoing site education and support, Ensure lines of communication remain open, Study specific SOPs, Electronic Data Capture, InForm, Phase Forward, Medidata, BioClinica, Oracle, Siebel, Share Vault, Phlex Global, PhlexEview, Egnyte, Trial Interactive, Microsoft Word, Excel, Publisher, PowerPoint, DocuSign
3-years' experience coordinating and assisting in clinical trials monitoring activities * Sound knowledge of Good Clinical Practices (ICH-GCP) and FDA regulations * Vast experience in billing and coding, data management, data entry, conducting billing practices, and other administrative tasks * Familiar with various computerized coding programs and electronic health records. * Advanced medical/scientific knowledge and medi...