Clinical Research Associate (CRA) United Kingdom **Exciting Opportunity: Clinical Research Associate (CRA) – Temporary 12 month Role to Support Clinical Trial Oversight** Are you a passionate and detail-oriented Clinical Research Associate (CRA) looking for a meaningful opportunity to contribute to cutting-edge clinical trials? At **Hologic Endomag** , we are looking for a **Clinical Research Associate** to join our mission of improving the lives of people with breast cancer and beyond. As a leader in the fight against cancer, **Hologic Endomag** is dedicated to developing cutting-edge technologies that empower clinicians and redefine patient care In this role, you'll play a pivotal part in advancing medical innovation by supporting site monitoring activities, maintaining data quality, and ensuring regulatory compliance for clinical studies across **Germany, Sweden,** **UK and US** . If you're ready to make a difference in healthcare and thrive in a dynamic environment, we want to hear from you! **What To Expect** + **Lead site monitoring activities** : Conduct site initiation, monitoring, and close-out visits independently, following study protocols and monitoring plans. + **Ensure regulatory compliance** : Guarantee site adherence to **ISO 14155** , **ICH-GCP** , and local regulatory requirements, as well as internal SOPs. + **Maintain data quality** : Verify source data and CRFs for accuracy, resolve data queries, and document protocol deviations. + **Manage Trial Master File (TMF)** : Ensure essential documents are filed accurately, address TMF gaps proactively, and maintain inspection readiness at all times. + **Collaborate and contribute** : Liaise with internal teams to support study timelines, participate in internal meetings, and contribute to audit/inspection readiness activities. **What We Expect** **Qualifications** : + A degree or equivalent in **life sciences, nursing, pharmacy** , or a closely related field. + **1–2 years of experience** as a CRA or in a similar clinical monitoring role. + Solid understanding of **ISO 14155** , **ICH-GCP** , and local regulatory requirements. + Proven experience in **TMF management** , including filing, QC, and ensuring inspection readiness. + Familiarity with clinical trial systems such as **eTMF, CTMS,** and **EDC platforms** . + Excellent organizational skills with a keen eye for detail. + Strong verbal and written communication skills. + Ability to work independently, prioritize tasks, and manage multiple sites/studies. + A proactive problem-solver with a collaborative approach. **Additional Requirements** : + Fluency in **English** (spoken and written) is essential. + **Swedish language skills** are highly desirable but not mandatory. + Willingness to travel, including occasional global travel, depending on study needs. **Why Join Us?** At **Hologic Endomag** , you’ll be part of a team that’s redefining what’s possible in cancer care. We believe in empowering our employees to make a difference, fostering innovation, and providing opportunities for growth. You’ll work alongside passionate professionals who share a commitment to excellence, collaboration, and making a lasting impact. As the **Clinical Training Manager** , you’ll play a central role in shaping the future of clinical education while championing technologies that save lives. \#LI-HE1