Clinical Research Associate (CRA)

Hologic, Inc.; United Kingdom; Hybrid; GBP 30,000 - 45,000; Full time

Job summary

A prominent medical technology firm in the UK seeks a Clinical Research Associate (CRA) for a temporary role focused on clinical trial oversight. This position involves conducting site visits, ensuring data quality, and compliance with regulatory standards. Candidates should have a degree in life sciences, nursing, or pharmacy, and experience in clinical monitoring. Fluency in English is essential, and Swedish language skills are a plus. Join a dynamic team dedicated to improving cancer care.

Qualifications

• 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 and QC.

Responsibilities

• Conduct site initiation, monitoring, and close-out visits independently.
• Guarantee site adherence to regulatory requirements and internal SOPs.
• Verify source data and CRFs for accuracy.

Skills

Site monitoring

Regulatory compliance

Data quality maintenance

Trial Master File management

Communication skills

Problem-solving

Education

Degree in life sciences, nursing, or pharmacy

Tools

eTMF

CTMS

EDC platforms

Job description

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? AtEndomag, a Hologic company we are looking for a Clinical Research Associateto join our mission of improving the lives of people with breast cancer and beyond.

As a leader in the fight against cancer, we are 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 acrossGermany, 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 toISO 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 inlife sciences, nursing, pharmacy, or a closely related field.
• 1–2 years of experienceas a CRA or in a similar clinical monitoring role.
• Solid understanding ofISO 14155,ICH-GCP, and local regulatory requirements.
• Proven experience inTMF management, including filing, QC, and ensuring inspection readiness.
• Familiarity with clinical trial systems such aseTMF, CTMS,andEDC 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 inEnglish(spoken and written) is essential.
• Swedish language skillsare highly desirable but not mandatory.
• Willingness to travel, including occasional global travel, depending on study needs.

Why Join Us?

AtEndomag, a Hologic company 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.

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