Clinical Trial Associate

The Clinical Trial Associate (CTA) is responsible for the management of the clinical trial documents, review of the site file document, assisting with the planning and development of the study documents, and oversight of clinical trial documents while ensuring the trial documents are managed in compliance with the protocol, ICH/GCP, applicable regulatory requirements, and applicable SOPs/Work Instructions.ResponsibilitiesStudy Planning and Conduct:Set up eTMF system, as appropriateAssist in preparation of documents including regulatory document templates, study binders, study communications and presentationsHandle incoming and outgoing shipments, as neededAssist with all aspects of initial study drug release including regulatory packet review and study-drug releaseAssist in the preparation of study-specific training materialsParticipate in the planning of investigator meetingsAssist in the development of case report forms and participate in the EDC and IVRS specification process, as appropriateFile clinical documents and maintain clinical research files (i.e., central files for studies)Participate in support of regional Field MonitorsInteract with sites as needed to respond to issuesMonitor and track ALL monitoring visit reports (in SharePoint and eTMF)Responsible for tracking of clinical trial progress including status update reports, as requiredParticipate in the review of clinical data at the case report form, data listing, and report table levelsAssist with final sign off of project and study-related documents including: informed consent forms, monitoring plans, synopses, protocols and amendments, IND Annual Updates, NDAs, and other documents, as requiredParticipate in clinical teams, including attending required meetings, and interact in a positive, professional manner.Maintain training up to date including review and sign off all SOPsIdentify and escalate issues appropriately.Set up clinical trials in ‘Clinicaltrial.gov’ and maintain until end-of-studySupport study team in IRB submission and updatesManage study meeting calendarDraft study meeting agendas and take study meeting minutesMaintain completion of required corporate training on standards, policies, work instructions by due datePerform other work-related duties as assignedQualificationsA bachelor's degree in biology, life sciences, health sciences, healthcare administration, psychology or business.At least 1-2 years of experience working in clinical trials, medical research, or a CRO.Familiarity with Good Clinical Practice (GCP) guidelines and Institutional Review Board (IRB) is essential.Understanding of relevant regulatory agencies like the FDA is preferred.Strong organizational skills and meticulous attention to details.Excellent communication skills, both written and verbal.What we look for in our peopleHighly motivated self-starter with an entrepreneurial spirit and commitment to personal and career developmentDesire to work in a quickly changing and fast-paced growing businessUnrelenting dedication to delivering results and a desire to shape the strategic goals of the business. Willing to roll up your sleeves to get the job doneAbility to overcome ambiguity and challenge the status quoManage multiple programs with competing and aggressive timelines, prioritize activities, and work independentlyExcellent written and oral communication skills; experienced presenter of key messages to broad audiences including Senior StakeholdersAs an equal opportunity employer, Neurocentria is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws.

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