Trial Master Files Representative

United StatesRemoteFull TimeEntry-level (exp-based)Posted 2 months agoVisa sponsorship available

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Role summary

Celerion is seeking a remote, full-time Trial Master Files Representative to join their clinical research team. This role involves ensuring the completeness and maintenance of Trial Master Files (TMF) for internal and external studies, meeting sponsor specifications. Responsibilities include creating file structures, indexing content, and communicating with clients, project managers, monitors, and sites to ensure compliance with protocols and regulatory requirements. A Bachelor's degree in a related scientific field and a minimum of 1 year of document management experience are required. Proficiency in MS Office and strong organizational and communication skills are essential.

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.

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.

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