Clinical Study Team Assistant I, Fsp
hace 1 semana
Clinical Study Team Assistant I (CSTA I)
Position Purpose:
The Clinical Study Team Assistant I (CSTA I) is an essential part of the Core Study Team and is responsible for supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations.
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.
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 Platform
- Analyze, interpret, and follow up on metrics
- Registry and/or Clinical Trial Management system(s) compliance and maintenance
- Tracking and oversight of study level information; follow up with functional lines as needed
- Liaising with cross functional study team members:
- Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines
- Quality Control (QC) of essential clinical trial, Clinical Study Report (CSR) and regulatory submission documentation
- Manages engagement of Independent Oversight Committees
- Provides support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities
- Assists the CSTL with oversight and tracking of Clinical Trial Budget spend
- Provides logístical/operational support to Study Management for Investigator Meetings
- Provides status updates on key tasks and activities to the CSTL and contribute to the Core Study Team Meetings as an active Core Study Team member
- 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
- On occasion, supports short term Clinical Operations Special Project requests (e.g. workstreams, initiatives, projects)
- Manages conflicting priorities to ensure excellent support to assigned study teams with general direction
- Manages own time to meet agreed targets; develops plans for shortterm work activities on own projects (timelines, work plans, deliverables)
- Completes training assigned by Client and/or Parexel, as necessary, including general training requirements, SOPs, system, and process related training.
- Adheres to EP and Client SOPs and processes
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