Clinical Research Associate Cra

Clinical Research Associate II / SR.
CRA (Level depends on experience)1 week ago Be among the first 25 applicantsAbout CTICTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
For more information, visitwww.ctifacts.comServe as main CTI contact for assigned study sitesConduct site visits (pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV)) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with study start-up activities, including feasibility, pre-study activities and site selectionCollect, review and track essential/regulatory documentsParticipate in and complete all general and study specific training as requiredParticipate in investigator, client and project team meetings;may include presentationsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to Clinical Project ManagerConduct remote monitoring and complete the related activities in accordance with study specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IPAssist with project-specific activities as member of Project Team Monitoring Plan, etc.
)Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required proceduresWhere applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
Provide regular updates to Sponsor/ ClientWhere applicable, support in contract negotiation with study sites, Investigator payments and tracking of site paymentsManage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring PlansIdentify an anticipate site issues and implement corrective actions or escalate as appropriateLiaise with Clinical Data Management for data cleaning activitiesServe as mentor/trainer for CRAs; may include conducting training/assessment visitsFunction in the role of Lead CRA for assigned projects(s0About CTICTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations.
We assist clinical research throughout the lifecycle of development, from drug concept to commercialization.
CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms.
For more information, visit You'll DoServe as main CTI contact for assigned study sitesConduct site visits (pre-study (PSV), site initiation (SIV), interim monitoring (IMV), and close-out (COV)) and complete site visit deliverables with quality and within given timelines in Monitoring Plan while adhering to all applicable regulatory requirements, SOPs and ICH GCPAssist with study start-up activities, including feasibility, pre-study activities and site selectionCollect, review and track essential/regulatory documentsParticipate in and complete all general and study specific training as requiredParticipate in investigator, client and project team meetings;may include presentationsCreate and implement subject enrollment strategies for assigned study sitesEnsure proper storage, dispensation and accountability of all Investigational Product (IP) and trial-related materialsPerform site management activities and provide ongoing updates of site status to Clinical Project ManagerConduct remote monitoring and complete the related activities in accordance with study specific Monitoring PlanUtilize systems and reports to track subject status, subject case report form (CRF) retrieval / source document review (SDV), regulatory documents, and IPAssist with project-specific activities as member of Project Team Monitoring Plan, etc.
)Participate in the development of CRFs and other study related documents (subject worksheets, Monitoring Plan, etc.)Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required proceduresWhere applicable, provide support to Regulatory Affairs Study Start-up Team in the preparation or revision of documentation for submission to Ethics Committee(s), Institutions Ethics Committees, Regulatory Authorities, Competent Authorities or Institutions Administration Boards, and follow-up the evaluation process until approval is available.
Provide regular updates to Sponsor/ ClientWhere applicable, support in contract negotiation with study sites, Investigator payments and tracking of site paymentsManage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring PlansIdentify an anticipate site issues and implement corrective actions or escalate as appropriateLiaise with Clinical Data Management for data cleaning activitiesServe as mentor/trainer for CRAs; may include conducting training/assessment visitsFunction in the role of Lead CRA for assigned projects(s0What You BringAt least 3 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human ResourcesFluent in EnglishBachelor's Degree or higher in allied health field such as nursing, pharmacy, or health / natural science, or RN with Associate's Degree, or 3-year Nursing Diploma with at least 2 years clinical nursing experience, or equivalent experience as determined by CTI Management and Human ResourcesPrevious experience in conducting clinical research studies in hospital setting, pharmaceutical company or CROYou need to be fully eligible to work in Brazil - CTI does not provide VISA SponsorshipThe role is meant in a office-based setting in São PauloProficiency in Spanish is considered an assetWhy CTI?
We support career progression – We have a structured mentoring program to provide the support you need to move forwardWe value education and training – We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training departmentWe value our people - We have never had a layoff in our 20-year history, support a work-life balance, and have provided cash bonuses every year for the past decadeOur culture is unparalleled – We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industryWe think globally and act locally – We have a global philanthropic program supporting our team's efforts to improve their local communities (click here to learn more about our "CTI Cares" program)We are looking toward the future – We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate (a recent report found that the average turnover for CROs in the US was 30%)Our work makes a difference – We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to marketImportant NoteIn light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an email address to guide you through our interview process.
Please ensure you are applying for jobs directly on our website () or from our verified LinkedIn page.Please NoteWe will never communicate with you via Microsoft Teams or text messageWe will never ask for your bank account information at any point during the recruitment processSeniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionResearch, Analyst, and Information TechnologyIndustriesResearch ServicesReferrals increase your chances of interviewing at CTI Clinical Trial and Consulting Services by 2xClinical Trial Manager - Sponsor DedicatedClinical Trial Manager II, CVRM - IQB, BrazilClinical Research Coordinator _Hospital Ana Nery _ Salvador de Bahia - Part time & fixed termWe're unlocking community knowledge in a new way.
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