Clinical Research Associate - Freelance

 Posted 2 days ago
     
2-5 years experience
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AI Summary

The CRA is responsible for monitoring study sites to ensure patient safety, data quality, and compliance with regulatory requirements. Key tasks include performing site visits, reviewing source data, and maintaining essential study documentation.

About this role

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions.

Clinical Research Associate is responsible for monitoring study sites, ensuring patient safety, data quality, and compliance with GCP, ICH, and regulatory requirements.

As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical or biotechnology company that is an industry leader within its therapeutic area.

Please, keep in mind that this is a part-time opportunity directed at Freelance Professionals only.

Key Responsibilities

  • Perform on-site and remote monitoring visits

  • Ensure protocol compliance, patient safety, and data integrity

  • Review CRFs and source data for accuracy

  • Verify informed consent procedures are followed

  • Manage investigational product accountability

  • Write and submit monitoring visit reports

  • Track issues and ensure timely follow-up with sites

  • Maintain eTMF/ISF documentation compliance

  • Support audits and inspections

  • Update CTMS and study systems with accurate data

Qualifications

  • Bachelor’s degree in Life Sciences, Nursing, or similar

  • 3+ year clinical research experience or relevant academic experience

  • Knowledge of GCP, ICH, and clinical trial processes

  • Strong communication and organizational skills

  • Ability to work independently and in teams

  • Fluent in English

  • Experience in CNS/Neuro studies is a big advantage

What We Offer

We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients.

Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference.

A Bit More About Us

Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

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