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Clinical Research Associate

Clinical Research Associate

TFS HealthScienceGdańsk, Pomeranian Voivodeship, Poland
16 days ago
Job description

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) dedicated to partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey. With expertise in full-service capabilities, resourcing, and Functional Service Provider (FSP) solutions, we’re currently looking for a skilled Clinical Research Associate (CRA) contractor to join our team in Poland .

About the Role

As a Clinical Research Associate at TFS HealthScience, you will be part of our high-performing SRS / FSP team, working exclusively with a prominent global pharmaceutical or biotech sponsor. Your role is essential in ensuring that clinical trials are conducted in accordance with protocol, ICH-GCP, and Polish regulatory requirements—from start-up through closeout.

Key Responsibilities

  • Submission & Amendment Support : Assist in preparing and submitting initial and amended documentation to local ethics committees and the Office for Registration of Medicinal Products (URPL).
  • Regulatory Reporting : Oversee timely and accurate safety reporting and periodic submissions to regulatory authorities and ethics committees.
  • Pre-activation & SIV Support : Contribute to site start-up activities and conduct / support Site Initiation Visits (SIVs).
  • Monitoring & Site Management : Conduct both on-site and remote monitoring to verify data quality, patient safety, and protocol compliance. Act as the main point of contact for investigational sites.
  • Documentation & Closeout : Ensure proper maintenance of the eTMF and manage site closeout activities in line with Polish and EU regulations.

Qualifications

  • Experience : At least 5 years of clinical monitoring experience in Poland, ideally within a CRO, pharmaceutical, or biotech setting.
  • Education : A university degree in Life Sciences, Nursing, Pharmacy, or a related field.
  • Knowledge : Excellent understanding of ICH-GCP guidelines, EU Clinical Trial Regulation (CTR), and local Polish regulatory framework (URPL, Central Ethics Committee).
  • Technical Skills : Competence with CTMS, eTMF systems, and remote monitoring tools.
  • Language : Fluency in Polish and English (written and spoken) is essential.
  • Communication : Strong organizational and interpersonal skills, with the ability to manage site relationships and ensure timely resolution of issues.

    • What We Offer

  • Competitive daily rate
  • Flexible work arrangement (hybrid / remote)
  • Opportunity to work with a globally recognized sponsor
  • A collaborative culture focused on quality, trust, and long-term growth

    • Why TFS HealthScience?

    Founded over 27 years ago in Lund, Sweden, TFS HealthScience has grown into a global, full-service CRO with more than 800 professionals across over 40 countries. We specialize in flexible clinical development and strategic resourcing solutions in key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

    Our values — Trust, Quality, Passion, Flexibility, and Sustainability — guide every aspect of our work. These principles foster a culture of respect, collaboration, and innovation, attracting top talent who want to make a meaningful impact.

    Make a Difference with Us

    Join TFS HealthScience and help shape the future of clinical research in Poland and beyond.

    Apply today to take your next professional step as a CRA contractor.

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    Clinical Research Associate • Gdańsk, Pomeranian Voivodeship, Poland