Clinical Research Associate II

1 semana atrás

São Paulo, São Paulo, Brasil MSD Tempo inteiro
Job Title: Clinical Research Associate

Merck & Co., Inc. is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in ensuring the success of our clinical trials by managing and monitoring sites, ensuring compliance with regulatory requirements, and providing high-quality support to investigators and site staff.

Main Responsibilities:
  • Act as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility for allocated sites.
  • Develop strong site relationships and ensure continuity of site relationships through all phases of the trial.
  • Perform clinical study site management/monitoring activities in compliance with International Conference on Harmonization Good Clinical Practice, Sponsor Standard Operating Procedures, Local Laws & Regulations, Protocol, Site Monitoring Plan and associated documents.
  • Gain an in-depth understanding of the study protocol and related procedures.
  • Participate in site selection and validation activities.
  • Perform remote and on-site monitoring & oversight activities using various tools to ensure data generated at site are complete, accurate and unbiased and subjects' rights, safety and well-being are protected.
  • Conduct site visits, including validation visits, initiation visits, monitoring visits, close-out visits, and record clear, comprehensive and accurate visit & non-visit contact reports.
  • Communicate with investigators and site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance.
  • Identify, assess and resolve site performance, quality or compliance problems and escalate as appropriate.
  • Work in partnership with Global Clinical Trial Operations country operations, finance, regulatory affairs, pharmacovigilance, legal and regional operations, HQ functional areas and externally with vendors and Institutional Review Board/Institutional Ethics Committee and Regulatory Authorities.
  • Manage and maintain information and documentation in Clinical Trial Management System, electronic Trial Master File and various other systems as appropriate and per timelines.
  • Support audit/inspection activities as needed.
  • Perform co-monitoring where appropriate.
Main Requirements:
  • Bachelor's degree with strong emphasis in science (pharmacy/biology).
  • Fluent in Portuguese and advanced English (verbal and written).
  • Previous experience as Clinical Research Associate.
  • Good understanding and working knowledge of clinical research, phases of clinical trials, current International Conference on Harmonization Good Clinical Practice & country clinical research law & guidelines.
  • Hands-on knowledge of Good Documentation Practices.
  • Developing skills in Site Management including management of site performance and patient recruitment.
  • Developing level of monitoring skill and independent professional judgment.
  • Ability to perform root cause analysis and implement preventative and corrective action.
  • Works effectively in a matrix multicultural environment.
  • The candidate must be either from São Paulo (Capital) or neighbor cities OR from the South region of Brazil.
About Us:

Merck & Co., Inc. is a global healthcare leader that is committed to improving lives through the discovery, development, and delivery of innovative medicines and vaccines. We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.

What We Offer:
  • Opportunity to work with a global healthcare leader.
  • Chance to develop your skills and expertise in clinical research.
  • Collaborative and inclusive work environment.
  • Competitive compensation and benefits package.

  • Clinical Research Associate II

    3 semanas atrás

    São Paulo, São Paulo, Brasil MSD Tempo inteiro

    Job DescriptionMain responsibilities: With the support of the Clinical Research Associate Manager, acts as primary site contact and site manager throughout all phases of a clinical research study, taking responsibility of allocated sites; Develops strong site relationships and ensures continuity of site relationships through all phases of the trial; ...

  • Clinical Research Associate

    Há 5 dias

    São Paulo, São Paulo, Brasil Cti Clinical Trial Services, Inc Tempo inteiro

    About the RoleCti Clinical Trial Services, Inc is seeking a highly skilled and experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for conducting site visits, collecting and reviewing essential documents, and ensuring compliance with regulatory requirements.Key ResponsibilitiesConduct site...

  • Clinical Research Associate

    Há 5 dias

    São Paulo, São Paulo, Brasil Cti Clinical Trial Services, Inc Tempo inteiro

    Job SummaryWe are seeking a highly experienced Clinical Research Associate to join our team at Cti Clinical Trial Services, Inc. As a Senior Clinical Research Associate, you will be responsible for managing clinical trials and ensuring compliance with regulatory requirements.Key ResponsibilitiesConduct site visits and complete site visit deliverables with...

  • Clinical Research Associate

    1 dia atrás

    São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    **Job Summary**Thermo Fisher Scientific is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for monitoring investigational sites to ensure compliance with regulatory requirements and Good Clinical Practice (GCP) guidelines.**Key Responsibilities**Conduct on-site monitoring visits...

  • Clinical Research Associate

    Há 6 dias

    São Paulo, São Paulo, Brasil Icon Tempo inteiro

    About ICONAt ICON, we pride ourselves on being a leader in the clinical research industry. Our team of experts is dedicated to advancing and improving patients' lives through innovative and high-quality research.Job SummaryWe are seeking a highly motivated and experienced Clinical Research Associate to join our team. As a Clinical Research Associate, you...

  • Clinical Research Associate III

    1 semana atrás

    São Paulo, São Paulo, Brasil MSD Tempo inteiro

    Job Title: Clinical Research Associate Merck & Co., Inc. is seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will be responsible for ensuring the successful execution of clinical trials in a country. Responsibilities: Accountable for performance and compliance for assigned protocols and sites in...

  • Clinical Research Associate II

    1 dia atrás

    São Paulo, São Paulo, Brasil Msd Tempo inteiro

    Job SummaryMsd is seeking a highly skilled Clinical Research Associate II to join our team. As a key member of our clinical research team, you will be responsible for ensuring the successful execution of clinical trials in a country.Key ResponsibilitiesEnsure compliance with ICH/GCP and country regulations, company policies and procedures, quality standards,...

  • Senior Clinical Research Associate

    Há 5 dias

    São Paulo, São Paulo, Brasil ICON Tempo inteiro

    About the RoleAs a Senior Clinical Research Associate at ICON, you will play a critical role in the success of our clinical trials. We are seeking an experienced and skilled professional to join our team and contribute to the delivery of high-quality clinical research services.Key ResponsibilitiesCoordinate activities to set up and monitor clinical studies,...

  • Lead Clinical Research Associate

    Há 6 dias

    São Paulo, São Paulo, Brasil PSI Tempo inteiro

    Job SummaryThe Lead Clinical Research Associate will oversee local Monitors, supervising clinical monitoring and site management activities to ensure the protection of trial subjects' rights, safety, and well-being, data quality, and study compliance on a country/regional level.Key ResponsibilitiesFacilitate regional projects as Lead Monitor and supervise...

  • Clinical Research Associate

    1 dia atrás

    São Paulo, São Paulo, Brasil Abbvie Tempo inteiro

    **Job Summary**At AbbVie, we are seeking a highly skilled Clinical Research Associate to join our team. As a Clinical Research Associate, you will play a critical role in ensuring the successful execution of clinical studies.**Key Responsibilities:**Monitor clinical investigative sites to ensure compliance with federal regulations, Good Clinical Practices...

  • Clinical Research Associate

    Há 6 dias

    São Paulo, São Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    About the RoleWe are seeking a highly experienced and skilled Clinical Research Associate - Principal to join our team at CTI Clinical Trial Services, Inc. As a key member of our team, you will be responsible for ensuring the successful execution of clinical trials across various therapeutic areas.Key ResponsibilitiesSite Management: Serve as the primary...

  • Senior Clinical Research Associate

    Há 6 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    About ICON PlcICON Plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Our CultureAt ICON, it's our people that set us apart. Our diverse teams enable us to...

  • Senior Clinical Research Associate

    Há 7 dias

    São Paulo, São Paulo, Brasil Icon plc Tempo inteiro

    Job SummaryWe are seeking a highly skilled and experienced Clinical Research Associate to join our team at Icon plc. As a Clinical Research Associate, you will play a critical role in the success of our clinical trials, working closely with our team to identify, select, initiate, and close-out investigational sites.Key ResponsibilitiesStudy Coordination:...

  • Clinical Research Associate

    Há 3 dias

    São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    About the RoleWe are seeking a highly skilled and experienced Clinical Research Associate (CRA) to join our team at Thermo Fisher Scientific. As a Sr. CRA, you will play a critical role in the success of our clinical trials, working closely with investigators, clients, and project teams to ensure the smooth execution of studies.Key ResponsibilitiesMonitor...

  • Clinical Research Associate I

    2 semanas atrás

    São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro

    Position OverviewThe Clinical Research Associate I plays a vital role in ensuring the integrity and compliance of clinical trials. This position involves the following key responsibilities:Site Monitoring: Implement a risk-based monitoring strategy to oversee investigator sites. Utilize root cause analysis and critical thinking to identify and rectify...

  • Senior Clinical Research Associate

    Há 6 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    About ICON PlcICON Plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.Our CultureAt ICON, it's our people that set us apart. Our diverse teams enable us to...

  • Senior Clinical Research Associate

    Há 4 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    About the RoleAs a Senior Clinical Research Associate at ICON, you will play a key role in the success of our clinical trials. Your primary responsibility will be to work independently and collaboratively with a close-knit team of highly qualified CRAs to identify, select, initiate, and close-out investigational sites for clinical studies in phases II -...

  • Senior Clinical Research Lead

    Há 5 dias

    São Paulo, São Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro

    Senior Clinical Research LeadAt CTI Clinical Trial Services, Inc., we prioritize maintaining a strong company culture across all locations, particularly with our remote workforce. We conduct weekly all-staff meetings where each department shares updates on studies or milestones achieved. Employees have the opportunity to participate in our CTI Cares...

  • Clinical Research Associate I

    Há 6 dias

    São Paulo, São Paulo, Brasil Novasyte Tempo inteiro

    Job OverviewAs a Clinical Research Associate at Novasyte, you will play a critical role in ensuring the successful execution of clinical trials. Your primary responsibility will be to conduct site monitoring visits to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and...

  • Clinical Research Coordinator

    1 dia atrás

    São Paulo, São Paulo, Brasil Novasyte Tempo inteiro

    Job SummaryWe are seeking a highly organized and detail-oriented Clinical Research Coordinator to join our team at Novasyte. As a Clinical Research Coordinator, you will play a critical role in supporting the success of our clinical trials by providing administrative and logistical support to our research team.Key ResponsibilitiesStudy Coordination: Assist...