Clinical Trial Associate

Position Summary

A biotechnology firm is actively looking for a Clinical Trial Associate to aid in managing clinical trials from initiation through to completion. This role involves supporting Clinical Trial Managers and diverse study teams to ensure schedules, documentation, and regulatory readiness are maintained effectively. This opportunity begins as a contract-to-hire position, with the possibility of becoming permanent contingent upon performance and organizational requirements.

Key Responsibilities

• Assist in daily clinical trial tasks, tracking timelines, study milestones, and deliverables.
• Ensure Trial Master File documentation is precise, complete, and prepared for inspections.
• Support site-related processes including start-up, document gathering, activation, and closing out studies.
• Monitor enrollment data, protocol deviations, monitoring actions, and document statuses.
• Organize study meetings, including preparing agendas, recording minutes, and tracking action items.
• Oversee vendor and CRO management by monitoring deliverable status and flagging issues.
• Work collaboratively with Clinical Operations teams and other cross-functional partners.
• Provide assistance with budget management, invoice processing, purchase orders, and contractual documentation.
• Ensure all tasks adhere to study protocols, ICH-GCP guidelines, relevant regulations, and company SOPs.

Qualifications

• Bachelor's degree in life sciences, healthcare, or related disciplines.
• One to three years of experience in clinical research or clinical operations.
• Experience with biotechnology or pharmaceutical sponsors is preferred.
• Knowledgeable in study start-up procedures, clinical documentation, and Trial Master File standards.
• Familiarity with ICH-GCP principles and clinical research language.
• Experience using clinical trial management tools such as CTMS or eTMF is an advantage.
• Strong organizational capabilities, communication skills, and ability to manage time effectively.
• Capacity to handle multiple priorities efficiently in a dynamic environment.

Ideal Candidate Profile

The suitable applicant is self-driven, meticulous, and capable of managing various studies and stakeholders simultaneously. This position is ideal for a clinical operations professional early in their career who desires increased responsibility and opportunities for advancement over time.