Clinical Trials Assistant (CTA)
We are looking for a highly organized and detail-oriented Clinical Trials Assistant (CTA) to support the coordination and administration of clinical studies. In this role, you will play a vital supporting part in ensuring clinical trials are conducted efficiently, accurately, and in compliance with regulatory and quality standards within pharmaceutical, biotech, or CRO environments.
About the Role
As a Clinical Trials Assistant, you will be the operational backbone of clinical study teams, handling essential documentation, communication, and coordination tasks. You will work closely with Clinical Research Associates (CRAs), Clinical Research Managers, and cross-functional teams to ensure that trial activities run smoothly and meet strict regulatory requirements.
Key Responsibilities
- Provide administrative and operational support for clinical trials across multiple sites and regions.
- Maintain and organize Trial Master File (TMF) documentation, ensuring completeness and compliance.
- Assist with the preparation, tracking, and filing of essential study documents.
- Coordinate communication between study teams, sites, sponsors, and vendors.
- Support site start-up activities, including document collection and regulatory submissions.
- Track study timelines, milestones, and deliverables to ensure timely execution.
- Assist in the preparation of study reports, presentations, and audit materials.
- Ensure accurate data entry and maintenance in clinical trial management systems (CTMS).
- Support monitoring visit logistics and follow-up activities.
- Ensure compliance with Good Clinical Practice (GCP), ICH guidelines, and internal procedures.
Qualifications and Experience
- Degree in Life Sciences, Healthcare, or a related field.
- Experience in clinical research, administration, or a similar support role is an advantage.
- Understanding of clinical trial processes and regulatory requirements is preferred.
- Familiarity with TMF, CTMS, and clinical documentation practices.
- Proficiency in Microsoft Office and document management systems.
Skills and Competencies
- Strong organizational skills with excellent attention to detail.
- Ability to manage multiple tasks and priorities in a structured manner.
- Clear communication skills for coordination with internal and external stakeholders.
- High level of accuracy and commitment to compliance and quality standards.
- Ability to work both independently and as part of a team.
- Proactive mindset with strong problem-solving abilities.
- Adaptability in a fast-paced and regulated environment.
What We Offer
- A collaborative and international clinical research environment.
- Opportunities to gain hands-on experience in pharmaceutical and biotech studies.
- Professional development and career growth within clinical research.
- Exposure to global clinical trial operations and regulatory frameworks.
- Competitive compensation and benefits package.
About: English Jobs Sweden
EnglishJobs.se specializes in recruiting international talent for Swedish companies. Since 2009 we have have helped over 8000 professionals connect with traditional companies such as as Ericsson, Skanska, ABB, Volvo and SAAB as well Swedish startups such as Spotify, TrueCaller, Klarna and Skype. We welcome talent with a multicultural background and knowledge of local cultures, languages and business markets. Industries we cover: Tech, Marketing & Communications, Events, Media, Retail, Travel, Hospitality, Finance, Gaming, Healthcare, Consulting
