Clinical Study Team Assistant I

hace 2 semanas

Desde casa, México Parexel A tiempo completo

The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating Procedures (SOPs). The role collaborates with global study team members and is responsible for multiple tasks that span from study start up to study close out which enables the efficient execution of clinical trials to high quality standards.**Key Accountabilities**:- Responsible for providing study level operational support to the study team from study start up to close out and submission- Maintains and oversees of study team shared spaces- Trial Master File (TMF) maintenance, compliance, and oversight- Analyze, interpret, and follow up on metrics- Maintains and oversees Study Team on Demand (STOD)- Analyzes, interprets, and follows up on metrics- Maintains client registries and systems as required to ensure compliance- Tracks and oversees study information; follows up with functional lines as needed- Liaises with cross functional study team members:- Provides study level reporting to support management of clinical trial data, clinical trial budget and timelines- Quality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submission- Supports engagement of Independent Oversight Committees- Provides support with audit and inspection readiness activities- Assists with oversight and tracking of clinical trial budget spend- Provides logístical and operational support for Investigator Meetings- Coordinates the translation of documents as required- Provides status updates on key tasks and contributes to study team meetings- Provides support to study teams with system setup and maintenance- May provide support for global study team communications to sites- Works proactively with mínimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes- Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards**Collaboration**- Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams.- Partners with the Global Study Manager and the Study Manager in providing site management, monitoring and vendor operational oversight and support- Collaborates with global cross functional study team members of varying levels of seniority**Compliance with Parexel standards**- Complies with required training curriculum- Completes timesheets accurately as required- Submits expense reports as required- Updates CV as required- Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirements**Skills**:- Effective verbal and written communication skills- Fluency in written and spoken English required**Knowledge and Experience (preferred)**:- Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research**Education**:- Bachelor’s of Art or Bachelor’s of Science with 0-3 years experience- Master’s of Art, Master’s of Business Administration or Master’s of Science with 0-1 years experienceLI-REMOTEBack to nav

  • Clinical Study Team Assistant I

    hace 2 semanas

    Desde casa, México Parexel A tiempo completo

    Parexel is looking for multiple Clinical Study Team Assistant I in Mexico, Argentina or Brazil! The Clinical Study Team Assistant I (CSTA I) is an essential part of the study team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with timelines, Good Clinical Practice (GCP), and client Standard Operating...

  • Clinical Study Team Assistant I, Fsp

    hace 3 semanas

    Desde casa, México Parexel A tiempo completo

    **Primary Responsibilities**:- Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction:- Management and oversight of Study Team shared spaces- TMF maintenance, compliance, and oversight- Analyze, interpret, and follow up on metrics- Management and oversight of Study Management...

  • Clinical Study Team Assistant I, Fsp

    hace 5 días

    Desde casa, México Parexel A tiempo completo

    Job Description Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction: - Management and oversight of Study Team shared spaces - TMF maintenance, compliance, and oversight - Analyze, interpret, and follow up on metrics - Management and oversight of Study Management Platform -...

  • Clinical Study Team Assistant I

    hace 4 días

    Desde casa, México Parexel A tiempo completo

    Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction: - Management and oversight of Study Team shared spaces - TMF maintenance, compliance, and oversight - Analyze, interpret, and follow up on metrics - Management and oversight of Study Management Platform - Analyze,...

  • Clinical Study Team Assistant I

    hace 2 días

    Desde casa, México Parexel A tiempo completo

    Provides study level operational support to the Core Study Team from study start up to close out and submission with general direction:- Management and oversight of Study Team shared spaces- TMF maintenance, compliance, and oversight- Analyze, interpret, and follow up on metrics- Management and oversight of Study Management Platform- Analyze, interpret, and...

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    hace 5 días

    Desde casa, México Parexel A tiempo completo

    As a Clinical Operations Assistant (COA) you will provide administrative support to various project team members. Your daily tasks will vary including site payments, management of site supplies, trial master file related tasks, and limited site facing tasks to support the efficiency, accuracy, and quality of the trials. Study Site Experience and strong...

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    hace 3 semanas

    Desde casa, México Parexel A tiempo completo

    External Job Description**Responsibilities**:- Lead the development of realistic study timelines, from design through final study reporting on priority programs- Maintaining accuracy of clinical study timeline information in Company data control systems (e.g., Planisware (PPM)- Tracking, documenting, and ensuring key stakeholder involvement and timely...

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    hace 4 días

    Desde casa, México IQVIA A tiempo completo

    **Job Overview** Perform daily administrative activities in collaboration with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure the accurate delivery of the Trial Master File (TMF). **Essential Functions** - Assist CRAs and RSU teams with updating and maintaining clinical documents and systems (e.g., TMF) to track site...

  • Clinical Trials Assistant, Cfsp

    hace 2 días

    Desde casa, México IQVIA A tiempo completo

    **Job Overview** Perform daily administrative activities in collaboration with Clinical Research Associates (CRAs) and Regulatory and Start-Up (RSU) teams to ensure the accurate delivery of the Trial Master File (TMF).**Essential Functions**- Assist CRAs and RSU teams with updating and maintaining clinical documents and systems (e.g., TMF) to track site...

  • Senior Clinical Research Associate I

    hace 1 semana

    Desde casa, México Parexel A tiempo completo

    **Parexel FSP is looking for multiple Sr CRAs in Mexico!**The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in accordance with applicable prevailing laws, Good Clinical Practices (GCP), and...