Senior CRA

2 tygodni temu

Bydgoszcz, Kujawsko-Pomorskie, Polska Pharmiweb Pełny etat
Job Description

Location:

Poland

Job Description:

As a Clinical Research Associate, you will take on various monitoring activities, contributing to clinical research across different therapeutic areas. Your role involves ensuring the adherence of clinical trials to the study protocol, ICH-GCP guidelines, and relevant regulations and standard operating procedures.

Key Responsibilities:
  • Undertake the initiation, monitoring, and closure of clinical studies at research sites, aligning with pertinent regulations, ICH-GCP guidelines, and standard operating procedures.
  • Prepare and execute submissions for regulatory and ethics approvals according to applicable regulations, ICH-GCP guidelines, and company procedures (e.g., initial CA and EC submissions, amendments, notifications, progress and safety reports, and contract negotiations without direct oversight).
  • Facilitate the contracting process between the Sponsor and Investigational sites.
  • Perform feasibility assessments and pre-study evaluations.
  • Document activities in compliance with ICH-GCP and company procedures.
  • Generate requested activity summaries and reports for the Manager.
  • In addition to regular monitoring tasks, Senior CRAs will assist in training and guiding junior CRA colleagues.
  • All Senior CRAs will partake in the company's International CTL (Clinical Team Leader) training program and may become junior CTLs under the supervision of a Senior Project Manager within 1-2 years.

Requirements:
  • Possess a bachelor's degree in life sciences.
  • Minimum of 1 year of experience in a CRA role.
  • Proficiency in English at an advanced level.
  • Strong IT skills.
  • Valid driver's license.
  • Effective communication, customer-centric approach, teamwork, time management, motivation for continuous learning and development.

What We Offer:
  • Competitive and appealing compensation package.
  • A dedicated and supportive team environment.
  • Exposure to a multinational workplace.
  • Regular team-building activities and company events.
  • Flexible hybrid work.