Associate Trial Master File Specialist

Associate Trial Master File Specialist

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

The Associate Trial Master File Specialist is responsible for the overall management and quality maintenance of essential clinical trial and other designated documents, including the set up and maintenance of the TMF, with a strong focus on ensuring that routine document management operations are performed with adherence with SOPs (Project and Corporate) and ICH/GCP/TMF guidelines. This position plays a key role in both paper and electronic TMF system management, by filing, organizing and maintaining paper and/or digital records and coordinating the document management activities performed by third parties, such as vendors, clinical sites, collaborators, as well as other internal and external team members, as required.

Responsibilities
  • Performs key Associate TMF Specialist duties in accordance with the company guidelines and work instructions (e.g., TMF set-up, quality management, reports and metrics, TMF quality control (QC)/ quality assurance (QA) activities, etc.).
  • Assists with the overall TMF quality and completion, including appropriate document filing and maintenance, cross-functional document coordination, including third party documents and TMF tracking and reporting to internal and external customers.
  • Ensures the TMF file structure follows applicable company approved TMF configuration, regarding ICH Guidelines for Good Clinical Practice, Good Documentation Practices and the TMF Reference Model, as required.
  • Ensures that all new and updated record information is accurately entered in the appropriate records management databases, such as RTS and eTMF Veeva Vault, for inspection readiness and highest quality of document governance.
  • Ensures that all assigned records are maintained in accordance with the company eTMF and/or other electronic data room storage SOPs, processes and data structure.
  • Assists project staff in tracking that essential documents are received and maintained across assigned studies and sites, including interfacing directly with sites to complete all document collections and check for accuracy.
  • Verifies receipt, reviews for identification and consistency, sorts, separates, photocopies, prints, scans, indexes, labels, and files a variety of clinical, TMF and other non-clinical documents, as assigned.
  • Collaborates with CRAs to ensure support for the collection and tracking of documents.
  • Ensures customer requests for retrieval, reproduction, and re-filing of requested records or electronic images (e.g. PDF, jpeg) are met in a timely manner.
  • Responsible for tasks associated with posting studies to ClinTrials.gov.
  • Assists with activities for off-site archival of clinical and TMF records.


Experience
  • Bachelor's degree preferred.
  • 1-2 years of experience in Clinical Operations.
  • Knowledge of clinical research concepts and able to work in a team environment.
  • Excellent organizational and planning skills.
  • Ability to build and maintain positive relationships with management, peers.
  • Ability to access technical information and read study materials such as protocols, MOPs, and User Guides, and understand the overall purpose and objectives of the documents.
  • Excellent written and verbal skills required.
  • Display strong analytical and problem-solving skills.
  • Applies knowledge learned from one task to the next.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Brings QC observations to the attention of project staff.


Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


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The Emmes Company, LLC is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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