Trial Master Files Representative

Celerion; United States; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading clinical research firm is seeking a Trial Master Files Representative for a remote, full-time position. The candidate will prepare and maintain Trial Master Files for clinical studies, ensuring compliance with protocols and regulatory requirements. A Bachelor's degree in a related field is required, along with excellent communication skills and proficiency in MS Office. This role offers an hourly rate of $24 - $29.

Qualifications

• Bachelor's degree in science, nursing, or biomedical discipline required.
• Experience in clinical research or Trial Master Files preferred.
• Minimum 1 year of document management experience is necessary.

Responsibilities

• Prepare and maintain Trial Master Files for studies.
• Create file structure and index content.
• Communicate with Sponsors and Project Managers.

Skills

Interpersonal skills

Oral communication

Written communication

Organizational skills

Collaboration

Computer skills

Education

Bachelor's degree in related field

Tools

MS Word

Excel

PowerPoint

Job description

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-TimeTrial Master Files Representativeto 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

$24 - $29 an hour

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.