Clinical Study Team Assistant I

Overview

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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 spans tasks from study start-up to study close-out to enable the efficient execution of clinical trials to high quality standards.

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: initiate and coordinate completion of study level forms and data entry into clinical operations applications and systems; provide study level reporting to support management of clinical trial data, budget, and timelines
• Quality Control (QC) of essential clinical trial, 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 contributes to Core Study Team Meetings
• 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 completion of assigned tasks according to timelines and quality standards
• On occasion, supports short term Clinical Operations Special Project requests
• Manages conflicting priorities to ensure excellent support to assigned study teams
• Manages own time to meet targets; develops plans for short-term work activities with timelines, work plans, and deliverables
• Completes training assigned by Client and/or EP, including 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
• Experience with clinical trial applications
• Effective verbal and written communication skills
• Ability to work independently but also as part of a larger team
• Ability to multitask and manage multiple priorities
• Fundamental knowledge of the CSTA role
• Self-motivated with ability to organize tasks to meet timelines and deliverables
• Knowledge of drug development process
• Attention to detail in document review, SOP adherence, and metrics
• Good problem solving and decision-making skills; ability to work in ambiguous situations and resolve problems

Language Skills

• Proficiency in written and spoken English

Seniority level

• Entry level

Employment type

• Full-time

Job function

• Health Care Provider

Industries

• Pharmaceutical Manufacturing
• Biotechnology Research
• Hospitals and Health Care

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