Clinical Trials Specialist

Há 7 horas

Brasil beBeeClinical Tempo inteiro US$48.000 - US$72.000
Job Overview

The Clinical Study Team Assistant I plays a pivotal role in the success of clinical trials. This position is responsible for providing operational support to the Core Study Team, ensuring compliance with regulatory regulations and industry standards.

Key responsibilities include managing study team shared spaces, maintaining and analyzing metrics related to TMF and SMT, as well as tracking and overseeing study-level information.

Additional tasks involve liaising with cross-functional team members, coordinating completion of study level forms and data entry into clinical operations applications and systems.

Responsibilities:
  • Provide operational support to the Core Study Team from start-up to close-out and submission
  • Manage and oversee study team shared spaces
  • Perform analysis and oversight of metrics related to TMF maintenance and compliance
  • Oversee management and analysis of metrics related to Study Management Platform
  • Ensure registry and/or Clinical Trial Management system(s) compliance and maintenance
  • Track and oversee study-level information; follow up with functional lines as needed
  • Liaise 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
  • Manage engagement of Independent Oversight Committees
  • Support CSTL and Clinical Quality Lead with Inspection Readiness Activities
  • Assist CSTL with oversight and tracking of Clinical Trial Budget spend
  • Provide logistical/operational support to Study Management for Investigator Meetings
  • Provide status updates on key tasks and activities to the CSTL and contribute to Core Study Team Meetings
  • Work proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes
  • Use established procedures and methodologies to ensure completion of assigned tasks according to timelines and quality standards
  • On occasion, support short-term Clinical Operations Special Project requests
  • Manage conflicting priorities to ensure excellent support to assigned study teams
  • Manage own time to meet targets; develop plans for short-term work activities with timelines, work plans, and deliverables
  • Complete training assigned by client and/or EP, including SOPs, system, and process-related training
  • Adhere to EP and Client SOPs and processes
Requirements:
  • 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)
  • 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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