Vaga de parceiro

Cra Ii / Home Based/ Brazil - Rio de Janeiro / RJ

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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

  • We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
  • Our Clinical Development model brings the customer and the patient to the center of everything that we do.
  • We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
  • Whether you join us in a Functional Service Provider partnership or a Full-Service environment, youll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
  • We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
  • Discover what our 29,000 employees, across 110 countries already know:**WORK HERE MATTERS EVERYWHERE****Why Syneos Health**- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
  • - We are committed to our Total Self culture - where you can authentically be yourself.
  • Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • - We are continuously building the company we all want to work for and our customers want to work with.
  • Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - were able to create a place where everyone feels like they belong.
  • **Job responsibilities**- Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance.
  • Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans.
  • Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
  • - Per the Clinical Monitoring/Site Management Plan (CMP/SMP):- Assesses site processes- Conducts Source Document Review of appropriate site source documents and medical records- Verifies required clinical data entered in the case report form (CRF) is accurate and complete- Applies query resolution techniques remotely and on site, and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines- Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture- Verifies site compliance with electronic data capture requirements- Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness.
  • Reconciles contents of the ISF with the Trial Master File (TMF).
  • Ensures the investigator/physician site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations.
  • - For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met.
  • Must be able to quickly adapt to changing priorities to achieve goals / targets.
  • - May act as primary liaison with study site personnel, or in collaboration with Central Monitoring Associate.
  • Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
  • - Prepares for and attends Investigator Meetings and/or sponsor face to face meetings.
  • Participates in global clinical monitoring/project staff meetings (inclusive of Sponsor representation, as applicable) and attends clinical training sessions according to the project specific requirements.
  • - Provides guidance at the site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions.
  • - Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes; completes assigned training as required.
  • - For Real World Late Phase, the CRA II will use the business card title of Site Management Associate II.
  • Additional responsibilities include:- Site support throughout the study lifecycle from site identification through close-out- Knowledge of local requirements for real world late phase study designs- Chart abstraction activities and data collection- Collaboration with Sponsor affiliates, medical science liaisons and local country staff- The SMA II may be requ

Informações Adicionais

  • Quantidade de Vagas 1
  • Jornada Não Informado
 

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