Clinical Trial Assistant (Cta) - Sponsor Dedicated

Syneos Health

2+ years

Not Disclosed

Bucharest Romania

10 Jan. 22, 2025

Job Description

Job Type: Hybrid Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Clinical Trial Assistant (CTA) - Sponsor Dedicated
Location: Bucharest, Romania (Hybrid Role)
Job ID: 25001330
Updated: January 20, 2025

Company Overview:

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We leverage clinical, medical affairs, and commercial insights to address modern market realities. Our Clinical Development model places the customer and patient at the center, continuously seeking ways to simplify and streamline our operations. With 29,000 employees across 110 countries, we are committed to delivering therapies and improving lives.

Why Syneos Health:

Career Development: Passionate about developing employees through career progression, training, and peer recognition.
Inclusive Culture: Committed to a Total Self culture where individuals can be their authentic selves and feel valued.
Diversity and Belonging: We celebrate diversity of thought, backgrounds, and perspectives to create a workplace where everyone feels like they belong.

Position Overview:

The Clinical Trial Assistant (CTA) will be responsible for supporting the Clinical Monitoring staff with site management activities, ensuring compliance with clinical protocols, and assisting with the maintenance of trial documents and project files. This role will be hybrid, with office visits required.

Key Responsibilities:

Compliance & Site Management:
- Perform activities in compliance with Corporate and Clinical Operations Policies, SOPs, and Work Instructions.
- Serve as a Sponsor representative for sites on assigned studies, ensuring adherence to protocol requirements and study procedures.
Document Management:
- Assist in maintaining the Trial Master File (TMF) and project files, including participation in audits.
- Prepare and maintain site manuals, reference tools, and other related documents.
- Track clinical and regulatory documents and update them for investigator sites, studies, project teams, or clients.
Clinical Tracking & Correspondence:
- Maintain and update clinical tracking information in databases.
- Manage shared mailboxes, process site requests, and route correspondence appropriately.
Logistics & Coordination:
- Coordinate ordering, packaging, shipping, and tracking of site supplies and materials.
- Assist in coordinating team meetings, attending, and preparing accurate minutes and action items.
Other Responsibilities:
- May handle receipt, tracking, and disposition of Case Report Forms (CRFs) and Queries.
- Complete necessary training to maintain awareness in the field of clinical research.

Qualifications:

Education: High School diploma or equivalent required.
Experience: Previous clinical trial experience is required.
Skills:
- Strong communication and interpersonal skills.
- Ability to handle administrative tasks efficiently.
- Attention to detail and organizational skills.
Other Requirements:
- Ability to travel to the office as required.

About Syneos Health:

Over the past 5 years, Syneos Health has worked on 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and conducted over 200 studies across 73,000 sites with 675,000+ trial patients.

Application Details:

Apply Now: [Application Link]
Join Our Talent Network: Stay connected to future career opportunities.

Syneos Health is dedicated to building a diverse, inclusive, and authentic workplace. If your previous experience doesn’t align perfectly with the job description, we encourage you to apply anyway, as transferable skills are often considered

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