[Hiring] Clinical Research Associate @Hologic

Role Description

We're looking for a Clinical Research Associate (CRA) to join our Clinical Development team on a 12-month fixed-term contract, supporting a portfolio of international clinical studies across Europe and the UK. This is an opportunity to work directly for an innovative MedTech company where your contribution will have a tangible impact on the development of technologies that improve outcomes for breast cancer patients worldwide.

This position offers broad exposure across clinical operations, monitoring and study delivery. You'll work closely with Clinical Project Managers, Clinical Development leaders, investigators and site teams, helping to ensure high-quality clinical data while supporting the successful delivery of global medical device studies.

You'll be involved in studies evaluating Endomag's breast cancer surgical guidance technologies, including Magseed® and related products. These studies include:

• Pre-market clinical investigations
• Post-market studies
• Investigator-sponsored research designed to support regulatory approvals, product development and new clinical indications

This role has been created to maintain monitoring continuity across ongoing studies, support site onboarding activities and ensure participant safety, study quality and regulatory compliance.

What You'll Be Doing

As a Clinical Research Associate, you'll take ownership of monitoring activities across a portfolio of clinical research sites, ensuring studies are conducted in accordance with protocol, ICH-GCP, ISO 14155 and applicable regulatory requirements. This is a hands-on CRA role, with a strong emphasis on independent site monitoring, data quality oversight and investigator engagement.

• Conducting site qualification, initiation, monitoring and close-out visits
• Performing source data verification (SDV) and source document review
• Supporting investigator sites throughout the study lifecycle
• Reviewing and maintaining Trial Master File (TMF) and Investigator Site File (ISF) documentation to ensure audit and inspection readiness
• Ensuring compliance with protocol requirements, informed consent processes and safety reporting procedures
• Working closely with investigators, research nurses and study coordinators to support recruitment and study progress
• Supporting study documentation, monitoring guidelines, case report forms and regulatory submissions
• Identifying and escalating study risks, issues and protocol deviations
• Contributing to investigator meetings and clinical study training activities
• Collaborating with Clinical Development, Project Management and external partners including CROs and research sites

Qualifications

• Previous experience working as a Clinical Research Associate
• Experience conducting independent site monitoring visits
• Strong understanding of ICH-GCP and clinical research regulations
• Experience ensuring data quality, protocol compliance and study documentation accuracy
• Ability to work independently within a remote, international team environment
• Excellent communication, organisation and stakeholder management skills
• Ability to travel regularly as part of the role

Requirements

• Oncology clinical research experience
• Medical device clinical trial experience
• Knowledge of ISO 14155 and European medical device regulations
• Experience monitoring studies across multiple European countries
• Familiarity with breast cancer clinical research

Benefits

• Salary: SEK 540,000 – 660,000 gross per year
• The final offer will depend on experience, skills, and alignment with internal pay structures
• Comprehensive benefits package including pension and insurances

Company Description

At Endomag, a Hologic company, we’re redefining cancer treatment and empowering clinicians worldwide with innovative medical solutions.

If you're a proactive CRA who enjoys working independently, building strong site relationships and contributing to studies that directly impact patient care, we'd love to hear from you.