| | | 20,000+ Fresh Resumes Monthly | |
|
|
| |
Click here or scroll down to respond to this candidateCandidate's Name
Street Address Cassia DrDavenport FL Street Address
PHONE NUMBER AVAILABLESummaryHighly skilled and experienced clinical research professional with over 15 years of experience in the pharmaceutical and healthcare industries. Proven ability to manage all aspects of clinical trials, from study design and initiation to data analysis and reporting. Strong understanding of regulatory requirements and ICH guidelines. Excellent communication, interpersonal, and organizational skills. Seeking a challenging opportunity in the insurance industry where I can leverage my clinical research expertise and contribute to the success of the company.SkillsClinical Research: Study design, initiation, monitoring, data analysis, reporting, regulatory compliance, ICH guidelinesProject Management: Budget management, timelines, resource allocation, risk assessment, communicationData Management: CRF completion, data entry, database management, data analysis, reportingRegulatory Affairs: IRB submissions, INDs, IDEs, safety reporting, adverse eventsCommunication: Written and verbal communication, interpersonal skills, conflict resolutionOrganizational Skills: Time management, attention to detail, multi-tasking, problem-solvingExperienceLife Changing Research LLC - Orlando, FL Contract Senior Clinical Research Associate November 2023 - PresentManaged all aspects of multiple clinical trials, from study design and initiation to data analysis and reportingEnsured compliance with regulatory requirements and ICH guidelinesDeveloped and implemented training programs for clinical research sitesProvided ongoing support and guidance to clinical research sitesPrepared and submitted essential document packages required for clinical site initiationReviewed and managed data on site and remotely; resolved issues on continuous basis to achieve timely database lock targetsProfessional Experience (Selected Highlights)United BioSource Corporation - Kansas City, MO Senior Clinical Research Associate July 2019 - September 2020Consistently completed on-site monitoring in accordance with project-specific timelinesEnsured timely completion of site monitoring reports, confirmation/follow-up lettersAssisted PM and management team by being an AIM leaderCovance (previously Chiltern) - Princeton, NJ Sr. Clinical Research Associate January 2017 - July 2019Monitored clinical trials for the execution of clinical research projectsPrepared and submitted essential document packages required for clinical site initiationCollaborated with the CTM/PM to ensure study milestones are metReviewed and managed data on site and remotelyChiltern International - Cary, NC Clinical Research Associate II April 2015 - January 2017Conducted all site visits including qualification, initiation, monitoring, motivational, audit support, and closeout visitsEnsured investigator site files are assembled appropriately and required documentation is in placeProactive communication with study sitesTracked patient recruitment and discussed potential risks and opportunities with the Project ManagerPrepared and conducted all site visits including qualification, initiation, monitoring, motivational, audit support, and closeout visitsAdditional ExperienceUniversity of Miami - Clinical Research Monitor (Contract)Florida Center for Gastroenterology - Clinical Research CoordinatorFlorida Hospital - Pepin Heart Institute - Clinical Research AssociateEnzon Pharmaceuticals - Clinical Research AssociateEducationMS Information TechnologyBS Health Care ServicesResident Insurance License 0620 - ADJUSTER - ALL LINES |
