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Clinical Trial Associate

fully flexible

Remote:

Full Remote

Contract:

Full time

Experience:

Mid-level (2-5 years)

Work from:

Poland

Offer summary

Qualifications:

Bachelor's degree in life sciences or healthcare, Previous experience in clinical trials context, Proficiency in MS Office and CTMS is a plus, Strong organizational skills.

Key responsabilities:

Coordinate clinical trial documentation and reports
Act as point of contact for study sites and sponsors
Assist with regulatory submissions
Maintain accuracy of the Trial Master File
Monitor project timelines and assist junior associates

TFS HealthScience Pharmaceuticals SME https://tfscro.com/

501 - 1000 Employees

See more TFS HealthScience offers

Job description

The Clinical Trial Associate (CTA) plays a critical role in supporting clinical research projects, ensuring smooth coordination, administration, and documentation of clinical trials. This role ensures compliance with all regulatory and company guidelines.

Team: SRS
Sponsor: You will be dedicated to a global pharmaceutical/biotech leader in innovative drug development, helping to bring life-changing therapies to market.

Key Responsibilities

Documentation Management: Coordinate the preparation, tracking, and distribution of clinical trial documentation and reports, ensuring quality and compliance.
Communication: Act as the primary point of contact for study sites, sponsors, and internal project teams, providing updates and resolving queries promptly.
Regulatory Support: Assist with regulatory submissions, ensuring all correspondence meets international standards.
Trial Master File (TMF) Maintenance: Maintain and ensure the accuracy of the TMF and other essential study documents, adhering to Good Clinical Practice (GCP) guidelines.
Project Monitoring: Assist in monitoring project timelines, deliverables, and study milestones, ensuring adherence to study objectives.
Mentorship: Provide guidance to junior associates and support the onboarding of new team members.

Qualifications

Education: Bachelor's degree in life sciences, healthcare, or related field, or equivalent experience.
Experience: Previous experience in clinical trials or a clinical research environment, preferably within a CRO or pharmaceutical setting.
Skills:
- Strong organizational skills, with the ability to prioritize and manage multiple tasks.
- Excellent communication skills in English and Polish, both written and verbal.
- Proficiency in MS Office; experience with clinical trial management systems (CTMS) is a plus.

What We Offer

Compensation & Benefits: Competitive salary and comprehensive benefits package.
Professional Growth: Opportunities for personal and professional development within a collaborative and innovative environment.
Impactful Work: Join a team committed to making a difference in the lives of patients.

About Us

Our journey began over 27 years ago in Lund, Sweden. As a full-service, global CRO, we build solution-driven teams working towards a healthier future. With over 800 professionals, TFS delivers tailored clinical research services across more than 40 countries, offering flexible clinical development and strategic resourcing solutions. Our expertise spans key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

Our Core Values: Trust, Quality, Passion, Flexibility, and Sustainability guide our decision-making and help us attract and retain talent. These values foster high employee engagement, mutual respect, and collaboration, driving us toward our shared goals and a culture of innovation and excellence.

Together, we make a difference.