Clinical Study Team Assistant I

Overview

Parexel FSP is hiring multiple Clinical Study Team Assistants in Brazil

The Clinical Study Team Assistant (CSTA) 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.

Organizational Relationships

• Reports to Parexel-assigned Line Management with day-to-day direction from Client. Refer to Organizational Chart for details regarding assigned role and associated reporting structure.
• Partners with the Clinical Study Team Lead (CSTL) in providing study level operational leadership and support to clinical study teams.
• Collaborates with global cross functional study team members of varying levels of seniority to ensure completion of tasks.

Primary Responsibilities

• Provides study level operational support to the Core Study Team from study start up to closeout 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: 1) Initiate and coordinate the completion of study level forms and data entry into various clinical operations applications and systems. 2) 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 with minimal 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 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 and Certification

• Bachelor's Degree (B.S or B.A) with 1 to 3 years' experience in pharma or CRO or Master's Degree (M.S, M.A or M.B.A).

Skills and Experience

• Proficient in Microsoft Office applications (Outlook, Word, PowerPoint, Excel, TEAMS)
• Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research.

Preferred Qualifications

• Science background
• Experienced with clinical trial applications
• Effective verbal and written communication skills
• Ability to work independently but also as part of a larger team with limited support from supervisor
• Ability to multitask and manage multiple competing priorities
• Has fundamental knowledge of the principles and concepts related to the CSTA role
• Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality
• Knowledge of drug development process
• Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
• Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems

Language Skills

• Proficiency in written and spoken English

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