Job Description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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

o Analyze, interpret, and follow up on metrics

• Maintains and oversees Study Team on Demand (STOD)

o 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:

o Initiates and coordinates the completion of study level forms and data entry into various clinical operations applications and systems

o 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

o Clinical Study Team Lead

o Global Study Manager

o Study Manager

o Start Up Project Manager

o TMF Study Owner

o Clinician, Process & Standards Lead

o 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:

o Seeks input from others when faced with a difficult situation

o Makes sound decisions within the scope of responsibility

o Focuses on resolving problems

Knowledge and Experience (preferred):

• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research

o 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