Trial Master Files Representative

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Celerion, a leader in the clinical research industry, currently has an opportunity for a Full-Time Trial Master Files Representative to join our team. This is a remote, home-based position and may be filled from any US geography. In this position, you will be be involved in the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies where Celerion has been contracted for the TMF services to meet Sponsor negotiated specifications. You will be responsible for maintenance of the TMF, creating a file structure and indexing contents. You will also communicate with client Sponsors, Project Managers, monitors, sites and other study contacts to ensure compliance to protocol, and regulatory/local requirements. Celerion, a leader in the clinical research industry, currently has an opportunity for a Full-Time Trial Master Files Representative to join our team. This is a remote, home-based position and may be filled from any US geography. In this position, you will be be involved in the preparation and the completeness of the Trial Master Files (TMF) for internal and external studies where Celerion has been contracted for the TMF services to meet Sponsor negotiated specifications. You will be responsible for maintenance of the TMF, creating a file structure and indexing contents. You will also communicate with client Sponsors, Project Managers, monitors, sites and other study contacts to ensure compliance to protocol, and regulatory/local requirements. Requirements: Bachelor's degree in related field such as science, nursing, or other biomedical discipline Experience in clinical research and/or Trial Master Files preferred Minimum 1 year document management experience. Excellent interpersonal and oral/ written communication skills. Highly organized and collaborative. Proficient computer skills, i.e., MS Word, Excel, PowerPoint. Ability to manage multiple priorities Celerion Values: Integrity Trust Teamwork Respect Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.