Clinical Trial Assistant I

Overview

This position is an excellent starting point for someone looking to establish a career in Clinical Operations. As a Clinical Trial Assistant I, you will be a key contributor on the clinical study team, supporting the planning, management, and execution phases of clinical trials. Reporting directly to the Director, your role will include ensuring that all clinical studies comply with regulatory guidelines and company standards.

Key Responsibilities

• Follow Clinical Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and International Conference on Harmonization (ICH) guidelines rigorously.
• Support preparation, review, distribution, and archiving of study-related documentation such as essential documents, plans, training materials, study guides, and manuals.
• Lead the creation and upkeep of trial master files (TMF) when applicable and coordinate with Contract Research Organizations (CROs) to identify and resolve discrepancies.
• Assist the project teams with sample management and create systems to track trial progress.
• Maintain and track study-specific information using databases, trackers, and other tools.
• Help prepare materials for meetings including organizing schedules, developing agendas, and recording minutes for internal study team discussions.
• Collect investigator and site details to facilitate study start-up, ongoing maintenance, and close-out processes.
• Communicate with investigator sites by providing study-specific information as needed.
• May act as a liaison for study sites and study monitors regarding clinical supplies, document collections, and preparations for close-out visits.
• Collaborate with cross-functional study teams and vendors to coordinate clinical trial activities effectively.
• Coordinate with Clinical Supply and related teams for shipment processing, returns, and assist in reconciling in-house drugs, specimens, and ancillary supplies.
• Support additional clinical operations functions as required.

Qualifications

• Bachelor's degree in biological sciences or a health-related discipline is required.
• Between one to three years of relevant experience in pharmaceutical or biotechnology industries, preferably within Clinical Operations or Clinical Research roles.
• Knowledge and understanding of GCP and ICH guidelines is essential.
• Ability to thrive in collaborative environments and eagerness to apply innovative methods and technology in a dynamic setting.
• Strong written and verbal communication, along with excellent interpersonal skills.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint) is expected; familiarity with MS Project or Smartsheet is advantageous.
• Availability for travel up to approximately 10% of the time.

Preferred Expertise

• Experience interacting with vendor platforms like eTMF, EDC, IRT, CTMS is a plus.
• Background in oncology clinical trials is preferred.
• Careful attention to detail is valued.