.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
