Clinical Research Associate m/f/d

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique MSD Temps plein

Job Description

Being part of a vibrant and dedicated team, the Clinical Research Associate acts as the face of the lab at the centers, safeguarding the entire product lineup.
They have a crucial role in every phase of a study, taking on the overall responsibility for overseeing clinical studies at designated sites.

Key Responsibilities:

  • Establishing and maintaining strong site relationships throughout the trial phases.
  • Conducting clinical study site management in accordance with relevant guidelines and regulations.
  • Understanding the study protocol thoroughly and coordinating tasks with other team members to ensure site readiness.
  • Providing insights on site selection and validation.
  • Monitoring and overseeing on-site activities to ensure data accuracy and subject well-being.
  • Performing various site visits and maintaining comprehensive visit reports.
  • Managing regulatory documentation for different study phases.
  • Communicating with Investigators and site staff regarding protocol adherence and performance.
  • Identifying and resolving site performance issues and escalating when necessary.
  • Collaborating with internal and external stakeholders to support site operations.
  • Documenting information in relevant systems in a timely manner.
  • Sharing knowledge and best practices within the team.
  • Supporting audit and inspection activities.
  • Contributing to the expansion of clinical research capabilities at new sites.

CORE Competency Expectations:

  • Proficiency in local languages and English, with strong communication skills.
  • Good understanding of clinical research principles and regulations.
  • Knowledge of GCP/ICH guidelines and ability to work within them.
  • Familiarity with Good Documentation Practices.
  • Skills in site management and patient recruitment.
  • Ability to analyze data and handle complex issues effectively.
  • Capability to implement corrective actions and problem-solving.

Behavioural Competency Expectations:

  • Demonstrating independence in monitoring activities.
  • Working autonomously across multiple protocols and therapy areas.
  • Having a positive and growth-oriented mindset.

Experience Requirements:

  • Minimum 2 years of direct site management experience in bio/pharma/CRO.

Educational Requirements: Preferred: B.A./B.S. in science or biology.

Our Offer:

  • Comprehensive training and support.
  • Career advancement opportunities.
  • Competitive package including bonuses and benefits.
  • Flexible work arrangements.

Requisition ID: R289487


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