Clinical Research Associate (CRA)

Hologic, Inc.; Manchester; On-site; GBP 35,000 - 45,000; Full time

Job summary

A leader in cancer care in Manchester is seeking a Clinical Research Associate to support clinical trial oversight. You will manage site monitoring activities, ensure regulatory compliance, and maintain data quality for clinical studies. The ideal candidate has a life sciences degree and 1-2 years of CRA experience. This is a temporary role that offers an opportunity to make a meaningful impact on cancer treatment and research.

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, QC, and ensuring inspection readiness.

Responsibilities

• Conduct site initiation, monitoring, and close-out visits independently.
• Ensure site adherence to ISO 14155, ICH-GCP, and local regulatory requirements.
• Verify source data and CRFs for accuracy, resolve data queries, and document protocol deviations.
• Ensure essential documents are filed accurately and maintain inspection readiness.

Skills

Site monitoring activities

Regulatory compliance

Data quality maintenance

Trial Master File management

Verbal and written communication

Organizational skills

Problem-solving

Education

Degree in life sciences, nursing, pharmacy, or related field

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? At Endomag, a Hologic company 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, 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 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 Endomag, 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.