Clinical Operations Coordinator

4 semanas atrás

São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiro
About the Role

We are seeking a highly organized and detail-oriented Clinical Operations Coordinator to join our team at Thermo Fisher Scientific. As a key member of our Clinical Operations team, you will play a critical role in supporting the successful execution of clinical trials.

Key Responsibilities
  • Provide administrative and technical support to project teams, ensuring timely completion of tasks and adherence to project timelines.
  • Support audit readiness by reviewing files and ensuring compliance with organizational SOPs and department guidance documents.
  • Assist with site activation activities, including developing critical paths and coordinating with internal departments.
  • Represent CRG personnel and provide local input into site tiering processes.
  • Perform department, internal, country, and investigator file reviews, documenting findings in appropriate systems.
  • Ensure allocated tasks are performed on time, within budget, and to a high-quality standard, proactively communicating any risks to project leads.
  • Provide system support and ensure system databases are always current.
  • Perform administrative tasks, including processing documents, performing eTMF reviews, and distributing mass mailings and communications.
  • Assist with coordination, compilation, and distribution of Investigator Site File (ISF) and Pharmacy binder materials and non-clinical study supplies to sites.
  • Assist with study-specific translation materials and translation QC upon request.
  • Maintain knowledge of and understand SOPs, client SOPs/directives, and current regulatory guidelines as applicable to services provided.
  • Conduct on-site feasibility visits (APAC only) and support scheduling of client and/or internal meetings.
  • Review and track local regulatory documents and provide system support.
  • Support RBM activities and the maintenance of study-specific documentation and systems.
  • Transmit documents to client and centralized IRB/IEC and maintain vendor trackers.
  • Support start-up team in Regulatory submissions and work directly with sites to obtain documents related to site selection.
  • Assist the project team with the preparation of regulatory compliance review packages and provide support as needed to coordinate with internal departments.
Requirements
  • High/Secondary school diploma or equivalent and relevant formal academic/vocational qualification. Bachelor's degree preferred.
  • Previous experience providing knowledge, skills, and abilities to perform the job (comparable to 0 to 1 year).
  • Ability to work in a team or independently as required.
  • Good organizational skills and strong attention to detail, with shown ability to handle multiple tasks efficiently and effectively.
  • Ability to effectively analyze project-specific data/systems to ensure accuracy and efficiency.
  • Strong customer focus and flexibility to reprioritize workload to meet changing project timelines.
  • Demonstrated ability to attain and maintain a good working knowledge of applicable Country Regulations, ICH Good Clinical Practices, and organization/Client SOPs and WPDs for all non-clinical/clinical aspects of project implementation, execution, and closeout.
  • Good English language and grammar skills and proficient local language skills as needed.
  • Good computer skills, proficient in MS Office (Word, Excel, and PowerPoint) and ability to obtain knowledge and master all clinical trial database systems.
  • Ability to successfully complete the organization's clinical training program.
  • Self-motivated, positive attitude, and good social skills.
  • Effective oral and written communication skills.
  • Good social skills.
  • Essential judgment and decision-making skills.
  • Capable of accurately following project work instructions.
  • Good negotiation skills.
  • Independent thinker.
  • Ability to lead risk and perform risk escalation appropriately.
Working Environment

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.

Able to work upright and stationary for typical working hours.

Ability to use and learn standard office equipment and technology with proficiency.

Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

May require travel. (Recruiter will provide more details.)

*Remote position*

#CRAdrive

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

  • Clinical Research Project Coordinator

    4 semanas atrás

    São Paulo, São Paulo, Brasil Bancroft School Tempo inteiro

    Job SummaryWe are seeking a highly skilled Clinical Research Project Coordinator to join our team. The successful candidate will be responsible for managing clinical trials from start to finish, ensuring timely delivery of tasks and maintaining high accuracy standards.Key Responsibilities Engage in clinical trial management on a day-to-day level Work closely...

  • Senior Clinical Research Associate

    2 semanas atrás

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

    Principal Clinical Research AssociateJob SummaryCTI Clinical Trial Services, Inc. is seeking a highly skilled and experienced Principal Clinical Research Associate to join our team. As a key member of our clinical operations team, you will be responsible for overseeing the management of clinical trials, ensuring compliance with regulatory requirements, and...

  • Global Clinical Operations Lead

    4 semanas atrás

    São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro

    Job Title: Lead, Global Clinical OperationsJob Summary: We are seeking a skilled Lead, Global Clinical Operations to join our team at Johnson & Johnson. As a key member of our organization, you will be responsible for leading global clinical operations, including learning & training and learning technology administration.Key Responsibilities: Oversee global...

  • Clinical Supply Operations Specialist

    2 semanas atrás

    São Paulo, São Paulo, Brasil Pfizer Tempo inteiro

    Role Summary:The Clinical Supply Operations Specialist is responsible for developing, coordinating, and executing clinical supply operational strategies across the Latin America region for global and local studies, including Investigational Product logistics (import/export).This role involves multiple responsibilities and collaborations across main Global...

  • Clinical Research Project Coordinator

    3 semanas atrás

    São Paulo, São Paulo, Brasil Bancroft School Tempo inteiro

    Job SummaryWe are seeking a highly skilled Clinical Research Project Coordinator to join our team. The successful candidate will be responsible for managing clinical trials from start to finish, ensuring timely delivery of tasks and maintaining high accuracy standards.Key ResponsibilitiesEngage in clinical trial management on a day-to-day basisWork closely...

  • Clinical Research Coordinator: Curitiba, Brazil

    4 semanas atrás

    São Paulo, São Paulo, Brasil Iqvia Tempo inteiro

    Job Title: Clinical Research CoordinatorWe are seeking a highly motivated and organized Clinical Research Coordinator to join our team at IQVIA in Curitiba, Brazil. As a Clinical Research Coordinator, you will be responsible for supporting the site team with various administrative tasks, including verifying research study information, researching queries,...

  • Clinical Operations Director

    4 semanas atrás

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

    Job Title: Clinical Operations DirectorAt Thermo Fisher Scientific, we are committed to enabling our customers to make the world healthier, cleaner, and safer. As a Clinical Operations Director, you will play a critical role in leading our clinical management team to deliver high-quality clinical trials and studies.Key Responsibilities:Provide strategic...

  • Logistics Operations Coordinator

    3 semanas atrás

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

    Job Summary:We are seeking a highly organized and detail-oriented Logistics Operations Coordinator to join our team at Thermo Fisher Scientific. As a Logistics Operations Coordinator, you will be responsible for assisting the Project Coordination/Logistic Operations sector in all activities described herein.Key Responsibilities:Collaborate and coordinate the...

  • Clinical Operations Specialist

    Há 4 dias

    São Paulo, São Paulo, Brasil Fortrea Tempo inteiro

    Leading global contract research organization, Fortrea, with decades of clinical development experience conducts operations in over 90 countries. This transforms drug and device development for partners and patients worldwide.The Clinical Research Associate I (CRA I) role is a crucial position responsible for executing a Clinical Research Project. The degree...

  • Clinical Operations Manager

    4 semanas atrás

    São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiro

    Job Title: Manager, Clinical OperationsKenvue is a global leader in the development and manufacturing of consumer goods, and we are currently seeking a highly skilled Manager, Clinical Operations to join our team.This role will be based in São José dos Campos, Brazil, and will be responsible for managing a team of clinical study management staff to ensure...

  • Clinical Trial Operations Manager

    2 semanas atrás

    São Paulo, São Paulo, Brasil Bancroft School Tempo inteiro

    Lead Clinical Trial OperationsLogin to a dynamic and growing team of professionals at Medpace, a leading Contract Research Organization (CRO) providing clinical development services to the biotechnology, pharmaceutical, and medical device industries.We are seeking a highly skilled Clinical Trial Operations Manager to join our Sao Paulo, Brazil team. As a key...

  • Clinical Operations Manager

    3 semanas atrás

    São Paulo, São Paulo, Brasil Msd Tempo inteiro

    This role is accountable for performance and compliance for assigned protocols in a country in accordance with regulations, policies, quality standards, and adverse event reporting requirements.The person is responsible for budget/finance aspects, execution, and oversight of clinical trial country submissions and approvals, and ensuring Site...

  • Clinical Operations Specialist

    4 semanas atrás

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

    Job SummaryWe are seeking a highly skilled Clinical Operations Specialist to join our team at Thermo Fisher Scientific. As a key member of our clinical operations team, you will be responsible for performing critical assessments and collaborating with study teams to determine the best approaches to manipulate subject data.Key ResponsibilitiesReview and...

  • Clinical Supply Operations Manager

    2 semanas atrás

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

    About the Role: This position supports clinical supply operations for global clinical trials, ensuring project activities comply with company and client requirements. As a representative and project lead, the successful candidate will coordinate efforts, provide recommendations and risks, and update project reports. Key Responsibilities:Develops...

  • Clinical Research Coordinator

    4 semanas atrás

    São Paulo, São Paulo, Brasil Icon Tempo inteiro

    Role OverviewWe are seeking a highly skilled Clinical Research Coordinator to join our team at ICON. As a key member of our site management team, you will be responsible for ensuring the smooth execution of clinical trials.Key ResponsibilitiesDevelop and maintain a thorough understanding of ICON's SOPs, ICH GCP guidelines, and relevant regulations.Ensure...

  • Logistics Operations Coordinator

    Há 18 horas

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

    Job DescriptionWe are seeking a skilled Logistics Operations Coordinator to join our team at Thermo Fisher Scientific.Job Summary:This role is responsible for assisting the Project Coordination/Logistic Operations sector in all activities described herein. The ideal candidate will have excellent communication and interpersonal relationship abilities,...

  • Operations Coordinator

    Há 5 dias

    São Paulo, São Paulo, Brasil ELEVATE Tempo inteiro

    About this RoleAs an Operations Coordinator, you will be responsible for supporting the project team in Minas Gerais or São Paulo, Brazil.About the TeamWe are a dynamic team at ELEVATE, and we are looking for a highly organized and detail-oriented individual to join us as an Operations Coordinator.Your ResponsibilitiesProvide administrative support to the...

  • Senior Clinical Operations Manager

    4 semanas atrás

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

    As a key member of the Hematology/Oncology Team at Thermo Fisher Scientific, the Senior Clinical Operations Manager will play a critical role in the overall success of the proposal development process. This includes providing leadership and ownership of operational strategies, bid defense hand-off, and accountability for all related operational proposal...

  • Marketing Operations Coordinator

    3 semanas atrás

    São Paulo, São Paulo, Brasil Tiktok Tempo inteiro

    Marketing Operations CoordinatorWe're looking for a talented individual to support the overall operations for Business Marketing at TikTok. As a Marketing Operations Coordinator, you will play a key role in ensuring the team's operational excellence, strategic partnership with leadership, and robust onboarding process.Key Responsibilities- Support the team...

  • Clinical Operations Team Lead

    Há 18 horas

    São José dos Campos, São Paulo, Brasil Kenvue Tempo inteiro

    At Kenvue, we're seeking an experienced Clinical Operations Team Lead to join our global organization. This is a unique opportunity to drive clinical study management and ensure the highest quality of work performed by our staff.About the RoleThe Clinical Operations Team Lead will be responsible for managing a team of clinical study management staff,...