Clinical Research Associate (CRA)
Hologic
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.
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