Clinical Study Team Associate II - FSP

Parexel FSP is looking for CSTA II to join our FSP team! Candidates can be based in Argentina, Brazil and Mexico.
Job Overview
The Clinical Study Team Associate II (CSTA II) 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 (may include but not limited to the following):
Operations
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:
Initiates and coordinates the completion of study level forms and data entry into various clinical operations applications and systems
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 logistical 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 minimal oversight 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
Collaboration
Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams
Partners with the Global Study Manager and the Study Manager in providing site management, monitoring and vendor operational oversight and support
Collaborates with global cross functional study team members of varying levels of seniority
Clinical Study Team Lead
Global Study Manager
Study Manager
Start Up Project Manager
TMF Study Owner
Clinician, Process & Standards Lead
Clinical Quality Lead
Subject Matter Expert (SME)
Provide support to CSTA managers for development and implementation of onboarding training for new hires and provide training to new hires
Mentor new hires and entry level CSTAs
Serve as Subject Matter Expert (SME) for key CSTA processes, systems and tasks
Work with CSTA managers to identify continuous improvement opportunities to enhance operational efficiencies
Compliance with Parexel standards
Complies with required training curriculum
Completes timesheets accurately as required
Submits expense reports as required
Updates CV as required
Skills
Proficient in Microsoft office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
Effective verbal and written communication skills
Fluency in written and spoken English required
Ability to work independently but also as part of a larger team
Ability to multitask and manage multiple competing priorities
Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality
Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
Good problem solving and decision-making skills:
Seeks input from others when faced with a difficult situation
Makes sound decisions within the scope of responsibility
Focuses on resolving problems
Knowledge And Experience (preferred)
Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research
See below Education section for minimum requirements
Science background
Experienced with clinical trial processes and applicable systems
Knowledge of drug development process
Requires fundamental knowledge of the principles of the role and applies these skills to achieve assigned tasks
Education
Bachelor’s of Art or Bachelor’s of Science with minimum of 3 years experience or
Master’s of Art, Master’s of Business Administration or Master’s of Science with minimum of 1 year experience

Work arrangement
Yes