Clinical Trial Associate / Clinical Trial Associate

Clinical Trial Associate - Permanent - Bonita Springs, FL

Are you ready to drive the future of clinical trials? Do you want to be at the heart of a company where precision meets purpose? Proclinical is seeking a Clinical Trial Associate to support the execution of clinical trials and ensure the integrity of trial data.

Primary Responsibilities:

This role involves managing administrative documentation, coordinating trial activities, and ensuring compliance with Good Clinical Practice (GCP), standard operating procedures (SOPs), and regulatory requirements.

Skills & Requirements:

• Bachelor's degree in a relevant scientific discipline (e.g., life sciences, health sciences, pharmacy, or nursing) preferred.
• Experience in clinical research, such as Clinical Research Coordinator or Clinical Trial Associate roles.
• Proficiency in Microsoft Office applications (Word, Excel, PowerPoint).
• Familiarity with EDC and CTMS systems.
• Experience maintaining TMF and/or ISF.
• Strong organizational and communication skills.
• Knowledge of Good Documentation Practices (GDP) and strong documentation abilities.
• ICH-GCP knowledge and training (required upon hire).

Key Responsibilities:

• Prepare start-up packages, protocols, informed consent forms (ICFs), study forms, and reference manuals.
• Track site activation status and training completion for study staff.
• Support study monitors in collecting essential documents and completing IRB/ethics submissions.
• Schedule and coordinate trial-related meetings, including drafting agendas, materials, and minutes.
• Assist in developing trial-specific tools and forms.
• Maintain trial systems, trackers, and operational forms in line with SOPs and study plans.
• Support electronic data capture (EDC) system activities, including data cleaning and query resolution.
• Assist in database setup, design, and user acceptance testing (UAT).
• Ensure accurate records of trial-related activities are maintained.
• Monitor and manage correspondence in study mailboxes to address or escalate site-related issues.
• Participate in internal audits and inspections to ensure compliance with regulatory standards.
• Maintain accurate and up-to-date trial documentation, including trial master files (TMF) and study files.
• Ensure adherence to GCP guidelines, SOPs, and regulatory requirements.
• Assist in preparing and submitting regulatory documents as needed.

Compensation:

$60 to $70 per hour.

If you are interested in this exciting opportunity, please Apply online using the form below. Only applications matching the job profile will be considered.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - Privacy Policy.