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Celerion

Trial Master Files Representative

Posted a day ago
$25 - $28 per hour
0-2 years experience
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The Trial Master Files Representative is responsible for the preparation, maintenance, and indexing of Trial Master Files to ensure compliance with sponsor specifications and regulatory requirements. They will communicate with sponsors, project managers, and study sites to maintain documentation integrity throughout the clinical research process.

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.

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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


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$25 - $28 an hour
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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.

 

Note: To make sure you don't miss important updates from us, please check your Spam folder for emails from @celerion.com, particularly interview invitations. If you find one there, mark it as "Not Junk" to ensure future Celerion emails land in your inbox. Please note that Gmail accounts have been particularly noted as routing to Spam.

 

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