Clinical Trial Associate

Are you ready to drive the future of clinical trials? Looking to be in the heart of a company where precision meets purpose?

About the role

Proclinical is seeking a Clinical Trial Associate to support the execution of clinical trials and ensure the integrity of trial data.

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.

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).

Pay

$60,000 - $70,000