Vaga de parceiro

Principal Clinical Research Associate - São Paulo / SP

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Detalhes da Vaga

  • Escolaridade Não Informado
  • Segmento Não Informado
  • Salário Não Informado
  • Área de AtuaçãoDiversos / Outros

O que você irá fazer

  • To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved.
  • Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.
  • **What You''ll Do**- Serve as main CTI contact for assigned study sites- Conduct 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 GCP- Assist with or oversee study start-up activities, including feasibility, pre-study activities and site selection- Collect, review and track essential/regulatory documents- Participate in and complete all general and study specific training as required- Participate in investigator, client and project team meetings; may include presentations- Ensure proper storage, dispensation, and accountability of all Investigational Product (IP) and trial-related materials- Perform site management activities and provide ongoing updates of site status to Clinical Project Manager- Conduct remote monitoring and complete related activities in accordance with study specific Monitoring Plan- Assist with project-specific activities as member of Project Team- Perform translation, customization, and review of Patient Information sheet and Informed Consent, protocol synopsis and other study applicable documents as per required procedures- Where 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/ Client- Where applicable, support or oversee the contract negotiation with study sites, Investigator payments and tracking of site payments- Manage ISF and TMF for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans- Identify and anticipate site issues and implement corrective and preventive actions or escalate as appropriate- Liaise with Clinical Data Management for data cleaning activities- Serve as mentor / trainer for CRAs; may include conducting training/assessment visits- Function in the role of Lead CRA for assigned project(s)- Identify and propose process improvements- Provide therapeutic area expertise to team members**What You Bring**- 8 years of clinical trial monitoring experience or equivalent experience as determined by CTI Management and Human Resources- Bachelor''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 Resources- Previous experience in conducting clinical research studies in hospital setting, pharmaceutical company or CRO**Why CTI?**At CTI, we recognize that our people are what make our company successful.
  • Our work moves medicine forward.
  • For that reason, we treat our team members with the respect they deserve, and our numbers show it:- We support career progression - We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward- We value education and training - We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department- We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked.
  • We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.
  • - Our 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 industry- We think globally and act locally - With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work.
  • Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.
  • - We are looking toward the future - We have had a consistent double-digit growth rate over the l

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