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Clinical Research Associate

Role overview

Qualifications

  • Degree or equivalent qualification in a health-related discipline, such as Medicine, Life Sciences, Nursing, or a related scientific field.
  • At least one year of clinically related experience, including a minimum of six months of experience in clinical research monitoring of investigational drug or device trials.
  • Familiarity with risk-based monitoring approaches, including on-site and remote monitoring.
  • Fluency in French, Dutch, and English is required.

Responsibilities

  • Serve as the primary point of contact for assigned investigative sites, providing relevant study information and coordinating with internal stakeholders.
  • Build effective working relationships with investigators and site staff, and support their understanding of the study objectives, protocol, and patient treatment principles.
  • Conduct site evaluation, initiation, routine monitoring, and close-out activities in accordance with the protocol, monitoring plans, and applicable regulations.
  • Support the safety and protection of study participants throughout the clinical trial.

Key facts

  • Remote from: Belgium
  • Full time
  • Clinical Research Associate
  • English, Dutch, French

Hard skills

Other skills

  • Mentorship
  • Collaboration
  • Communication
  • Active Listening
  • Presentations
  • Planning
  • Organizational Skills
  • Critical Thinking

About the company

Capstan Therapeutics logo

Capstan Therapeutics

Biotechnology

Capstan is a biotechnology company with a mission to multiply the therapeutic possibilities for patients by developing targeted in vivo RNA technologies. Our CellSeeker™ tLNP platform technology comprises proprietary targeted lipid nanoparticles (tLNP) that are composed of LNPs conjugated with a recombinant protein binder, such as a monoclonal antibody. tLNPs are designed to deliver payloads, including mRNA or gene editing tools, capable of reprogramming specific cell types in vivo. Capstan’s CellSeeker™ technology has the potential to generate transformative therapies with possible applications across a broad range of disease areas, including autoimmune disorders, oncology, fibrosis, and monogenic blood disorders. For more information, please visit www.capstantx.com.

Company details

IndustryBiotechnology
Company size51 - 200

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Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, FacebookInstagramX and YouTube.

Job Description

AbbVie is looking for a Clinical Research Associate (CRA) to support clinical studies in Belgium. The role partners with investigators and site teams to promote effective study delivery, data quality, compliance, and a positive site experience.

Key Responsibilities

  • Serve as the primary point of contact for assigned investigative sites, providing relevant study information and coordinating with internal stakeholders.
  • Build effective working relationships with investigators and site staff, and support their understanding of the study objectives, protocol, and patient treatment principles.
  • Conduct site evaluation, initiation, routine monitoring, and close-out activities in accordance with the protocol, monitoring plans, applicable regulations, GCP, ICH Guidelines, AbbVie SOPs, and quality standards.
  • Support the safety and protection of study participants throughout the clinical trial.
  • Develop and adapt site engagement strategies based on study requirements and local site insights, using available tools to track progress and measure impact.
  • Apply knowledge of the protocol, scientific principles, therapeutic area, and patient journey to support recruitment, retention, and protocol compliance.
  • Conduct ongoing risk assessments and collaborate with the Central Monitoring team to identify potential study performance or patient safety issues.
  • Investigate site risk signals and ensure appropriate preventive and corrective action plans are implemented when required.
  • Ensure the quality and timely submission of data and safety information by site personnel, while maintaining audit and inspection readiness.
  • Identify and recommend potential investigators and sites, contribute to assigned initiatives, and support the development of less experienced CRAs through mentoring and training.

Qualifications

  • Degree or equivalent qualification in a health-related discipline, such as Medicine, Life Sciences, Nursing, or a related scientific field.
  • At least one year of clinically related experience, including a minimum of six months of experience in clinical research monitoring of investigational drug or device trials.
  • Familiarity with risk-based monitoring approaches, including on-site and remote monitoring.
  • Knowledge of relevant therapeutic areas and the ability to apply scientific concepts to clinical trial conduct.
  • Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
  • Fluency in French, Dutch, and English is required.
  • Strong collaboration, communication, active listening, and presentation skills, with the ability to build effective relationships with investigators and site teams.
  • Strong planning and organizational skills, with the ability to manage competing priorities and deadlines.
  • Ability to use technology, monitoring tools, and available resources to support site engagement and study execution.
  • Ability to apply sound judgment, critical thinking, and functional expertise when addressing clinical site issues.
  • Self-motivated and quality-focused, with a commitment to integrity and compliance with AbbVie’s Code of Business Conduct and Leadership Values.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html

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