Clinical Trial Assistant

About The Role

The Clinical Trial Assistant (CTA) plays a vital role in supporting the operation of clinical trials by ensuring precise documentation, handling pharmacy technician tasks, and maintaining regular communication with clinical sites, coordinators, and patients. This role requires adherence to good clinical practices and internal procedures to support trials assessing the safety and efficacy of new drugs and medical devices. Due to the regulated nature of clinical studies, accurate record keeping and compliance monitoring are critical.

Key Responsibilities

• Oversee adherence to study protocols and all applicable local, state, and federal regulations and institutional policies.
• Accurately maintain documentation related to study participation, including case report forms, drug dispensation logs, and regulatory paperwork.
• Procure necessary drugs or devices for study progress.
• Stay informed about developments in clinical research by reviewing scientific literature, engaging in continuing education, and attending relevant industry events.
• Assist with and prepare for quality assurance audits by sponsors, authorities, or oversight bodies.
• Organize and manage the space designated for study-related equipment and inventory supplies.
• Contribute to the development of study protocols, including procedural guidelines for administration and data collection.
• Coordinate with sponsors to arrange site visits and address issues like incomplete data.
• Identify any protocol-related problems, inform investigators, and support resolution efforts including protocol amendments.
• Dispense clinical drugs or devices, determine appropriate dosages, and provide necessary instructions.
• Perform any additional duties assigned as part of clinical trial support.

Job Expectations

• Effectively organize, archive, and manage all trial-related documents such as protocols, SOPs, resource documents, dispensing records, email correspondence, and training materials.
• Keep updated and accurate correspondence records.
• Carry out clinical trial administration adhering to good clinical practices and SOPs.
• Provide logistical support, including entering orders for study subjects and sites and managing the delivery of trial medications and supplies.
• Occasional travel may be necessary.

Qualifications

• High School Diploma or GED equivalent.
• Previous experience within healthcare or life sciences, with clinical trial experience preferred.
• Exceptional attention to detail and commitment to completing administrative tasks thoroughly.
• Ability to collaborate effectively within a team.
• Strong verbal and written communication skills.
• Proficiency in MS Office applications such as Excel, Word, and PowerPoint.
• Possession of a current Missouri State Pharmacy Technician Registration is required.

Preferred Skills

• Well-developed organizational and interpersonal abilities.

Work Environment and Physical Requirements

The role primarily involves desk work, with frequent sitting or standing for long intervals (up to 90% of a shift). The position also requires walking, talking, and listening regularly. Occasionally, lifting up to 25 pounds may be necessary. Typical workplace noise is moderate, with interruptions and competing demands typical of an office environment.

Additional Information

Company Culture: The organization values patient-centric care, client satisfaction, decisive action, talent growth, collaboration, open communication, diversity, and continuous innovation.

Anti-Fraud Notice: Be aware of fraudulent job offers impersonating the employer. Genuine recruitment never requires personal information or training fees during application processes.

Diversity & Inclusion: The company is an Equal Opportunity Employer committed to a diverse workplace, embracing various identities and perspectives.

Accommodation Policy: Reasonable accommodations are available for qualified individuals with disabilities during any part of the hiring process.