[Hiring] Clinical Study Team Assistant II @Parexel

Role Description

The Clinical Study Team Assistant II (CSTA II) is an essential part of the Core Study Team and is responsible for driving and/or 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.

• Provides study level operational support to the Core Study Team from study start up to close out and submission:
• 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
• 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:
• Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems
• 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 logistical/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 and independently to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes
• Ensures the completion of assigned tasks according to timelines and to required quality standards
• Serves as Subject Matter Expert or Technical Resource for key clinical trial processes, systems and tasks
• On occasion, supports short term Clinical Operations Special Project requests (e.g. workstreams, initiatives, projects)
• Provides support to CSTA Managers for development and implementation of on-boarding training for new hires:
• Provide training to new hires
• Mentor new hires and junior CSTAs
• Serves as Subject Matter Expert for key CSTA processes, systems and tasks
• Works with CSTA Managers to identify continuous improvement opportunities to enhance operational efficiencies
• Independently manages conflicting priorities to ensure excellent support to assigned study teams
• Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables)
• Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training
• Adheres to EP and Client SOPs and processes

Qualifications

• Bachelor’s of Science degree or equivalent
• 3 years’ experience within the CRO/Pharmaceutical industry

Requirements

• Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel)
• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research
• Proficiency in written and spoken English