Senior Clinical Research Lead

Há 5 dias

São Paulo, São Paulo, Brasil CTI Clinical Trial Services, Inc Tempo inteiro
Senior Clinical Research Lead
At 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 committees, which not only enhance our culture but also focus on various philanthropic initiatives.

Key Responsibilities
  1. Act as the primary CTI liaison for designated study sites.
  2. Conduct site visits, including pre-study, site initiation, interim monitoring, and close-out, ensuring deliverables are met with quality and within established timelines while complying with all relevant regulatory standards, SOPs, and ICH GCP.
  3. Assist in or oversee study initiation activities, including feasibility assessments, pre-study tasks, and site selection.
  4. Gather, review, and manage essential and regulatory documentation.
  5. Engage in and complete all necessary general and study-specific training.
  6. Participate in investigator, client, and project team meetings, which may involve presentations.
  7. Develop and implement subject enrollment strategies for assigned study sites.
  8. Ensure proper handling, storage, and accountability of all Investigational Products and trial-related materials.
  9. Carry out site management tasks and provide ongoing updates regarding site status to the Clinical Project Manager.
  10. Perform remote monitoring and related activities in accordance with the study-specific Monitoring Plan.
  11. Utilize systems and reports to monitor subject status, case report form retrieval, regulatory documents, and Investigational Products.
  12. Contribute to project-specific activities as a member of the Project Team.
  13. Assist in the creation of case report forms and other study-related documents.
  14. Translate, customize, and review Patient Information sheets, Informed Consent forms, protocol synopses, and other relevant study documents as required.
  15. Support the Regulatory Affairs Study Start-up Team in preparing or revising documentation for submission to Ethics Committees and Regulatory Authorities, ensuring follow-up until approval is obtained.
  16. Where applicable, assist or oversee contract negotiations with study sites and manage investigator payments.
  17. Manage the Investigator Site File and Trial Master File for all assigned study sites in accordance with SOPs or study-specific Monitoring Plans.
  18. Identify potential site issues and implement corrective actions or escalate as necessary.
  19. Collaborate with Clinical Data Management for data cleaning activities.
  20. Serve as a mentor and trainer for Clinical Research Associates, which may include conducting training and assessment visits.
  21. Function as the Lead CRA for assigned projects.
  22. Identify and suggest process improvements.
  23. Provide therapeutic area expertise to team members.
Qualifications
  1. A minimum of 8 years of experience in clinical trial monitoring or equivalent experience as determined by CTI Management and Human Resources.
  2. A Bachelor's Degree or higher in a relevant field such as nursing, pharmacy, or health/natural sciences, or an RN with an Associate's Degree, or a 3-year Nursing Diploma with at least 2 years of clinical nursing experience, or equivalent experience as determined by CTI Management and Human Resources.
  3. Prior experience in conducting clinical research studies within a hospital, pharmaceutical company, or CRO setting.
Why Choose CTI? At CTI, we understand that our employees are the cornerstone of our success. Our work is pivotal in advancing medical treatments. We are committed to fostering career growth through internal promotions and structured mentoring programs. We also provide educational support, including tuition assistance and partnerships with educational institutions to develop relevant programs. Our commitment to our employees is evident in our history of no layoffs and our support during challenging times, such as the COVID-19 pandemic. We emphasize work-life balance with generous vacation policies, hybrid work options, and paid parental leave. Our culture has been recognized with multiple awards, and we pride ourselves on our global reach while maintaining strong local connections. We are dedicated to making a difference in the lives of patients with chronic and critical illnesses, focusing on bringing life-changing therapies to market.

  • 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

    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...

  • 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,...

  • Clinical Research Project Lead

    Há 6 dias

    São Paulo, São Paulo, Brasil ODC Life Sciences Tempo inteiro

    About the RoleWe are seeking a highly skilled Clinical Research Project Manager to join our team at ODC Life Sciences.Key Responsibilities:Develop and implement detailed clinical research project plansCollaborate with cross-functional teams to ensure project successIdentify and mitigate project risksMonitor and report project progressEnsure compliance with...

  • Senior Site Activation Lead

    Há 4 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    About the RoleWe are seeking a highly skilled and experienced Senior Site Activation Lead to join our team at ICON Plc. As a key member of our clinical research organization, you will be responsible for driving and accelerating the activation of investigator sites, ensuring timely and quality delivery of key landmarks.Key ResponsibilitiesDevelop and maintain...

  • Clinical Research Manager

    Há 4 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Job OverviewThe Clinical Research Manager is accountable for the execution and oversight of local operational clinical trial activities and has ownership, oversight, and impact on local regulatory and financial compliance, at a country operations level at Fortrea, in compliance with ICH GCP and country regulations.Key ResponsibilitiesSignificant impact on...

  • Senior Site Activation Lead

    Há 6 dias

    São Paulo, São Paulo, Brasil Icon Tempo inteiro

    About the RoleWe are seeking a highly skilled Senior Site Activation Lead to join our team at ICON. As a key member of our Clinical Research organization, you will be responsible for ensuring the successful and timely activation of investigative sites for our clinical trials.Key ResponsibilitiesDevelop and implement site activation strategies and plans to...

  • 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...

  • Senior Site Activation Lead

    Há 6 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    About the RoleWe are seeking a highly skilled and experienced Site Activation Lead to join our team at ICON Plc. As a key member of our Clinical Research organization, you will be responsible for ensuring the successful and timely activation of investigative sites for our clinical trials.Key ResponsibilitiesDevelop and implement site activation strategies...

  • Clinical Research Director

    Há 6 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Job SummaryWe are seeking a highly skilled Clinical Research Manager to join our team at Fortrea, a leading global contract research organization. As a Clinical Research Manager, you will be responsible for managing clinical trials from feasibility to close-out, ensuring compliance with regulatory requirements and company standards.Key ResponsibilitiesManage...

  • Clinical Research Operations Manager

    1 dia atrás

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Job SummaryFortrea is seeking an experienced Clinical Research Operations Manager to join our team. As a key member of our clinical research operations team, you will be responsible for the execution and oversight of local operational clinical trial activities.Key ResponsibilitiesOversee local regulatory and financial compliance at a country operations...

  • Senior Site Activation Lead

    Há 6 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    About the RoleWe are seeking a highly skilled and experienced Site Activation Lead to join our team at ICON Plc. As a key member of our Clinical Research organization, you will be responsible for ensuring the successful and timely activation of investigative sites for our clinical trials.Key ResponsibilitiesDevelop and implement site activation strategies...

  • Senior Site Activation Lead

    Há 6 dias

    São Paulo, São Paulo, Brasil Icon Plc Tempo inteiro

    About the RoleWe are seeking a highly skilled and experienced Site Activation Lead to join our team at ICON Plc. As a key member of our Clinical Research organization, you will be responsible for ensuring the successful and timely activation of investigative sites for our clinical trials.Key ResponsibilitiesDevelop and implement site activation strategies...

  • Senior Director for Clinical Study Leadership

    Há 6 dias

    São Paulo, São Paulo, Brasil SINOVAC BIOTECH LTD. Tempo inteiro

    Job DescriptionJob Title: Senior Director for Clinical StudyAbout Us: SINOVAC BIOTECH LTD. is a leading biotechnology company dedicated to the research, development, and commercialization of innovative vaccines.Job Summary: We are seeking a highly experienced Senior Director for Clinical Study to lead our clinical study operations and ensure the successful...

  • Senior Director for Clinical Study Leadership

    1 dia atrás

    São Paulo, São Paulo, Brasil SINOVAC BIOTECH LTD. Tempo inteiro

    Job DescriptionJob Title: Senior Director for Clinical StudyAbout Us: SINOVAC BIOTECH LTD. is a leading biotechnology company dedicated to the research, development, and commercialization of innovative vaccines.Job Summary: We are seeking a highly experienced Senior Director for Clinical Study to lead our clinical study operations and ensure the successful...

  • 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...

  • Lead Clinical Research Strategist

    2 semanas atrás

    São Paulo, São Paulo, Brasil Allucent Tempo inteiro

    At Allucent, we are committed to assisting small to medium-sized biopharmaceutical firms in effectively navigating the intricate landscape of clinical trials, ultimately delivering transformative therapies to patients worldwide.We are seeking a Lead Clinical Research Strategist to become a vital member of our dynamic team (hybrid*/remote). In this role, you...

  • 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...

  • 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...