Clinical Trial Assistant

Do you enjoy keeping clinical trials organized, compliant, and audit-ready?
Are you someone who thrives on supporting clinical research teams and ensuring studies run smoothly behind the scenes?

We are looking for a Clinical Trial Assistant (CTA) to support the execution of clinical studies within our Clinical Affairs team. In this role, you will work closely with Clinical Project Leaders and Clinical Research Associates to ensure efficient study operations, high-quality documentation, and regulatory compliance.

As a CTA, you will play a key role in maintaining trial documentation, coordinating study logistics, supporting regulatory submissions, and ensuring audit-ready clinical trial files. You will collaborate with internal teams, clinical sites, CROs, and vendors to support the successful execution of clinical research activities.

Clinical trial operations

• Maintain and update study files, including the electronic Trial Master File (eTMF), ensuring accuracy, completeness, and audit readiness.

• Track and manage essential study documentation such as investigator CVs, site contracts, training logs, ethics committee approvals, and study correspondence.

• Support preparation and distribution of investigator site files, site initiation materials, and monitoring tools.

• Coordinate study logistics, including shipment and tracking of clinical trial supplies.

• Assist with regulatory and EC/IRB submissions during study start-up and throughout the study lifecycle.

• Support responses to site queries and collect required documentation from study sites.

• Perform periodic quality reviews of clinical documentation to ensure compliance with GCP, ISO 14155, and internal procedures.

• Contribute to audit and inspection readiness, including preparation and follow-up on findings.

Administrative support

• Schedule and coordinate internal and external meetings, investigator calls, and teleconferences.

• Prepare meeting agendas and minutes when required.

• Act as a liaison between internal teams, clinical sites, CROs, and vendors for administrative tasks.

• Support the team with invoice tracking, reporting activities, and document control.

• Maintain study trackers, calendars, and shared documentation to support the clinical team.

• Provide administrative support for the Clinical and Medical Affairs departments.

• Assist with document reviews, version control, and archiving of completed studies.

Required

• Bachelor’s degree in Life Sciences, Health Sciences, or a related field, or equivalent experience.

• 1–3 years of experience in clinical research, for example as a Clinical Trial Assistant, Clinical Coordinator, or similar role.

• Familiarity with Good Clinical Practice (GCP), ISO 14155, and regulatory requirements.

• Strong attention to detail and accuracy.

• Excellent communication, organizational, and time management skills.

• Ability to manage multiple priorities in a fast-paced environment.

• Proficiency with Microsoft Office (Word, Excel, PowerPoint).

• A collaborative mindset and ability to support cross-functional teams.

Preferred

• Experience in medical device clinical trials or implantable technologies.

• Understanding of data protection regulations (e.g., GDPR) and ethical research practices.

• Experience with clinical systems such as eTMF, CTMS, or EDC.