Trial Master Files Representative /Remote/

As a Trial Master Files Representative at Celerion, your primary responsibilities will revolve around the preparation, maintenance, and organization of Trial Master Files. You will ensure that TMFs meet all Sponsor specifications while communicating with project stakeholders to maintain compliance with both regulatory and protocol requirements, ensuring successful execution of clinical studies.

To qualify for the Trial Master Files Representative role at Celerion, candidates should hold a bachelor's degree in a related field such as science or nursing. Additionally, having at least one year of experience in clinical research or document management is preferred, along with strong skills in organization and communication.

The essential skills for a successful Trial Master Files Representative at Celerion include excellent interpersonal, oral, and written communication abilities, along with strong organizational capabilities. Proficiency in MS Office (Word, Excel, PowerPoint) is also critical to efficiently manage documentation and facilitate collaboration across various teams.

Yes, the Trial Master Files Representative position at Celerion is a fully remote role, allowing you to work from anywhere within the United States. This setup promotes flexibility and work-life balance while still maintaining a strong connection with your colleagues in the clinical research field.

The expected salary range for the Trial Master Files Representative at Celerion is between $22 and $25 per hour, depending on experience and qualifications. Celerion values its employees and is committed to providing a competitive compensation package that reflects their contributions.

To ensure the completeness of Trial Master Files, I would start by clearly understanding the Sponsor’s specifications and guidelines. I would systematically organize documents, regularly check for required pieces, and communicate with project managers and clients to verify that all necessary materials are included, maintaining detailed checklists as I proceed.

In my previous roles, I have been involved in managing various clinical trial documents, ensuring their accuracy and compliance. I have utilized electronic document management systems extensively, organizing and indexing files to facilitate easy access for team members while ensuring that all documentation adheres to regulatory standards.

To effectively manage multiple priorities, I prioritize tasks based on deadlines and importance while using project management tools to stay organized. I also maintain open lines of communication with my team to adjust priorities as needed and ensure all responsibilities are met efficiently and on time.

I believe in proactive and clear communication with both clients and study sites. I always ensure that any updates or requirements are conveyed promptly and professionally. Additionally, I aim to build rapport and trust through consistent follow-ups and responsiveness to any inquiries or concerns they may have.

One of the biggest challenges in maintaining Trial Master Files is ensuring that all documents adhere to regulatory requirements and the specific expectations of each Sponsor. To overcome this, I stay well-informed about current regulations and best practices while utilizing established protocols for document management to minimize risks.

Certainly! In my last role, I was part of a clinical study team where I streamlined the documentation process by implementing a more efficient filing system for the TMF. This resulted in improved collaboration between departments and allowed us to meet deadlines ahead of schedule, ultimately contributing to the study's success.

I have extensive experience working within the regulatory frameworks governing clinical trials, including GCP, ICH guidelines, and FDA regulations. I continually educate myself about updates and changes in these guidelines to maintain compliance and ensure the integrity of the clinical research process.

When faced with a difficult conversation about TMF compliance, I would approach the situation with empathy and a solution-focused mindset. I would ensure the discussion is private, outline the specific compliance issues clearly, and work collaboratively with the team member to identify practical solutions and foster an open dialogue for future improvements.

In my previous experience, I have utilized various electronic document management systems, including Veeva Vault and MasterControl. These tools have helped me maintain streamlined access to documents, ensure version control, and promote collaboration among team members while adhering to regulatory compliance.

I am excited about the opportunity to work at Celerion because of the company’s commitment to innovation in clinical research and its strong values. I am passionate about contributing to projects that ultimately help bring new treatments to market, and I believe my experience and skills are closely aligned with the goals and mission of Celerion.