Clinical Study Team Assistant II - FSP

at  Parexel

In Parexel FSP we are currently looking for a Clinical Study Team Assistant II to join our team in Mexico. The position will be remote.
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:
o Management and oversight of Study Team shared spaces

o TMF maintenance, compliance, and oversight

• Analyze, interpret, and follow up on metrics

o Management and oversight of Study Management Platform

• Analyze, interpret, and follow up on metrics

o Registry and/or Clinical Trial Management system(s) compliance and maintenance
o Tracking and oversight of study level information; follow up with functional lines as needed

o 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

o Quality Control (QC) of essential clinical trial, Clinical Study Report (CSR) and regulatory submission documentation
o Manages engagement of Independent Oversight Committees
o Provides support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities
o Assists the CSTL with oversight and tracking of Clinical Trial Budget spend

o 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:

o Provide training to new hires

o 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

EDUCATION:

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

SKILLS AND EXPERIENCE:

• 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.

LANGUAGE SKILLS:

• Proficiency in written and spoken English

Please refer the Job description for details