Clinical Trials Compliance Specialist

hace 3 semanas


Buenos Aires, Argentina PSI CRO A tiempo completo
About the Role

We are seeking a highly skilled Quality Assurance Auditor to join our team at PSI CRO. As a Quality Assurance Auditor, you will play a critical role in ensuring the high quality standards of our clinical trials and internal company processes.

Key Responsibilities
  • QA Study Audits: Prepare, conduct, and report on QA study audits, internal systems and location audits, vendor qualification audits, and maintain relevant communication with the auditee.
  • Project Team Collaboration: Communicate with project teams regarding QA study audits, including follow-up and resolution.
  • Documentation and Training: Assemble QA audits documentation and train PSI Operations staff in quality management topics.
Requirements
  • Qualifications: MD, PharmD, or degree in life sciences is a plus.
  • Experience: A minimum of 3 years' experience in quality management or quality assurance in a clinical study environment.
  • Skills: Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations. Team-oriented with superior communication and interpersonal skills, including a proactive attitude to tasks and projects.
  • Additional Requirements: Excellent time management skills, demonstrated ability to meet tight deadlines, multi-task/be flexible, and thrive in a fast-paced work environment. Full working proficiency in English and proficiency in MS Office applications.
About PSI CRO

PSI CRO is a company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we'll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.



  • Buenos Aires, Argentina IQVIA A tiempo completo

    Join IQVIA Biotech as a Lead Clinical Research Specialist. We are seeking a qualified professional with diverse therapeutic expertise, particularly in areas such as Oncology, Cardiovascular, Internal Medicine, and Ophthalmology. This position offers the flexibility of a home-based role. KEY RESPONSIBILITIES: As a Lead Clinical Research Specialist, you will...


  • Buenos Aires, Argentina Worldwide Clinical Trials A tiempo completo

    **Requisition Number** **6764** **Employment Type***: **Regular** **Who we are** We’re a global, midsize CRO that pushes boundaries, innovates, and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    **Join us as a **Clinical Trials Assistant!**: **What You´ll Do** Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. **Essential Functions** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up...


  • Buenos Aires, Argentina PSI CRO A tiempo completo

    Job Title: Clinical Trials Regional Project LeadAt PSI CRO, we are seeking a highly skilled and experienced Clinical Trials Regional Project Lead to join our team.The successful candidate will be responsible for coordinating activities of project teams, ensuring milestones are met, and maintaining consistency of Clinical Operations processes across...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** Support Clinical Research Associates and Regulatory teams in administrative tasks to ensure accurate Trial Master File. **Key Responsibilities** - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with accurately updating and maintaining clinical documents and systems (e.g., Trial Master File (TMF)) that...


  • Buenos Aires, Argentina PSI A tiempo completo

    Job Title: Clinical Trials Regional Project LeadAbout the RoleWe are seeking a highly skilled Clinical Trials Regional Project Lead to join our team at PSI. As a key member of our Clinical Operations department, you will play a critical role in ensuring the successful execution of clinical trials across regions.Key ResponsibilitiesCoordinate project team...


  • Buenos Aires, Argentina Psi CRO Ag A tiempo completo

    Job Title: Clinical Trials Regional Project LeadAt PSI CRO Ag, we are seeking a highly skilled Clinical Trials Regional Project Lead to join our team. As a key member of our Clinical Operations department, you will play a crucial role in ensuring the successful execution of clinical trials across regions.Key Responsibilities:Coordinate project team...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    Join us as a Clinical Trials Assistant! - What You´ll DoPerform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start-Up teams, to ensure a complete and accurate Trial Master File delivery. Essential Functions - Assist Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) team with...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    Join IQVIA Biotech as a Lead Clinical Research Specialist. We are seeking a dedicated professional with diverse therapeutic expertise who is eager to engage in various therapeutic areas such as Oncology, Cardiovascular, Internal Medicine, and Ophthalmology. This position is designed to be home-based. KEY RESPONSIBILITIES: The Lead Clinical Research...


  • Buenos Aires, Argentina Psicro A tiempo completo

    Clinical Trials Proposal Manager **About the Role** At Psicro, we're seeking a skilled Clinical Trials Proposal Manager to join our team. As a key member of our proposal development team, you will play a critical role in coordinating all phases of our proposal process, ensuring a win rate of 30% and higher. **Key Responsibilities** * Develop high-quality...


  • Buenos Aires, Argentina Psicro A tiempo completo

    Clinical Trials Proposal Manager **About the Role** At Psicro, we're seeking a skilled Clinical Trials Proposal Manager to join our team. As a key member of our proposal development team, you will play a critical role in coordinating all phases of our proposal process, ensuring a win rate of 30% and higher. **Key Responsibilities** * Develop high-quality...


  • Buenos Aires, Argentina Icon plc A tiempo completo

    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.We are currently seeking a Clinical Research Associate II Specialist to join our...


  • Buenos Aires, Argentina Novasyte A tiempo completo

    Job Overview The Clinical Trial Educator (CTE) will provide information and education on clinical trial inclusion and exclusion criteria to trial coordinators and healthcare providers. Also provides in-service presentations with the goal to increase patient enrollment. Works in partnership with CRAs and other field-based medical teams for optimal trial...


  • Buenos Aires, Argentina Psi CRO Ag A tiempo completo

    Clinical Trials Quality Assurance AuditorAt PSI CRO Ag, we are seeking a highly skilled Clinical Trials Quality Assurance Auditor to join our international team. As a key member of our organization, you will play a crucial role in ensuring the highest quality standards within our clinical trials and internal company processes.Key Responsibilities:Conducting...


  • Buenos Aires, Argentina IQVIA A tiempo completo

    Career Advancement OpportunitiesAre you looking to take your career to the next level as a Clinical Research Associate? We offer a comprehensive training program to help you develop the skills and expertise needed to succeed in this role.As a CRA, you will be responsible for conducting site visits, monitoring clinical trials, and ensuring compliance with...


  • Buenos Aires, Argentina Innovative Trials A tiempo completo

    **Job Purpose** The Clinical Enrollment Manager (CEM) will perform site optimisation services in order to boost patient recruitment for clients’ clinical trials. The site optimisation services include, but are not limited to: Site Optimisation Calls - the telephone-based coaching of study sites by motivating them to explore recruitment strategies and...


  • Buenos Aires, Argentina Psi CRO Ag A tiempo completo

    Job SummaryWe are seeking a highly skilled and experienced Clinical Trials Regional Project Lead to join our team at Psi CRO Ag. As a key member of our Clinical Operations department, you will be responsible for coordinating activities of project teams, ensuring milestones are met, and maintaining consistency of Clinical Operations processes across...


  • Buenos Aires, Argentina Psicro A tiempo completo

    PSI is a leading Contract Research Organization (CRO) with over 25 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake...

  • Clinical Trial Manager

    hace 3 semanas


    Buenos Aires, Argentina ICON Plc A tiempo completo

    Job Summary:ICON Plc is seeking a highly skilled Clinical Trial Manager to join our team. As a Clinical Trial Manager, you will be responsible for overseeing the planning, execution, and successful completion of clinical trials. This critical role requires strong leadership and collaboration skills, as well as the ability to manage site relationships and...


  • Buenos Aires, Argentina MSD A tiempo completo

    Job SummaryWe are seeking a highly skilled Clinical Research Associate to join our team at MSD. As a Clinical Research Associate, you will be responsible for ensuring the smooth conduct of clinical trials at assigned sites, ensuring compliance with regulatory requirements, and maintaining strong relationships with site staff.Key ResponsibilitiesDevelop and...