Clinical Trial Assistant
il y a 2 jours
Proclinical are partnering with a small Contract Research Organisation (CRO) that provides high-quality clinical research services to the pharmaceutical, biotech, and medical device industries. They are an exciting CRO who are developing in size and are working with exciting companies.They are currently seeking a highly motivated Clinical Trial Assistant to join their team in Ghent.
**Summary**:
**Responsibilities**:
- Assist with the preparation and submission of regulatory documents, including informed consent forms, study protocols, and clinical study reports.
- Assist with the tracking and management of study materials, including investigational products and clinical trial supplies.
- Collect and manage study data in accordance with the study protocol and regulatory requirements.
- Assist with the preparation and maintenance of study-related documents, including study files, study plans, and meeting minutes.
- Prepare and distribute study-related materials to study team members, including investigators and study coordinators.
- Support study close-out activities, including the finalisation of study reports and archiving of study documents
- Ensure compliance with all applicable regulations and guidelines, including ICH-GCP, local regulatory requirements, and company SOPs.
- Ensure that all study team members are trained on the study protocol, study procedures, and other study-specific requirements.
- Communicate study progress, issues, and risks to internal and external stakeholders, including sponsors, investigators, and study teams.
**Requirements**:
- Bachelor's degree in a relevant field (life sciences, healthcare, or related field).
- At least 2 years of experience as a Clinical Trial Assistant (CTA) in a clinical research setting.
- Strong knowledge of ICH-GCP and regulatory requirements.
- Excellent organisational and communication skills.
- Ability to manage multiple priorities and meet deadlines.
- Strong interpersonal skills and ability to work effectively in a team environment.
- Fluent in English with Dutch and French being strong assets.
They offer a competitive salary and benefits package, a dynamic and friendly work environment, and opportunities for career growth and development. This position will be based in Ghent with the opportunity for hybrid working.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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