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Clinical Study Team Assistant I

hace 4 meses

REMOTE, 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.

Responsible for providing study level operational support to the study team from study start up to close out and submissionMaintains and oversees of study team shared spacesTrial Master File (TMF) maintenance, compliance, and oversightAnalyze, interpret, and follow up on metricsMaintains client registries and systems as required to ensure complianceTracks and oversees study information; follows up with functional lines as neededInitiates and coordinates the completion of study level forms and data entry into various clinical operations applications and systemsProvides study level reporting to support management of clinical trial data, clinical trial budget and timelinesQuality control of essential clinical trial documentation including components of the Clinical Study Report (CSR) and regulatory submissionProvides support with audit and inspection readiness activitiesProvides logistical and operational support for Investigator MeetingsCoordinates the translation of documents as requiredKnowledge and Experience:
• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research
• Experienced with clinical trial processes and applicable systemsEducation:
• 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 experience
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