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Clinical Research Associate (CRA)

Hologic Inc.

United Kingdom

Hybrid

GBP 35,000 - 45,000

Full time

30+ days ago

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Job summary

A leading healthcare company is seeking a Clinical Research Associate (CRA) for a temporary 12-month role to support clinical trial oversight. The role involves leading site monitoring activities, ensuring regulatory compliance, and maintaining data quality for trials across the UK and Europe. The ideal candidate should have a degree in life sciences and 1-2 years of experience in a similar role. Fluency in English is essential, with Swedish as a desirable additional skill.

Qualifications

  • 1–2 years of experience as a CRA or in a similar clinical monitoring role.
  • Solid understanding of ISO 14155 and ICH-GCP.
  • Proven experience in TMF management including filing and QC.

Responsibilities

  • Conduct site initiation, monitoring, and close-out visits independently.
  • Guarantee site adherence to ISO 14155, ICH-GCP, and local regulatory requirements.
  • Verify source data and CRFs for accuracy.

Skills

Strong verbal and written communication skills
Excellent organizational skills
Proactive problem-solving
Ability to work independently
Collaboration

Education

Degree in life sciences, nursing, 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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