LumiThera is looking for a Clinical Trial Administrator (CTA) to provide support to the Clinical Department. This individual will maintain the eTMF for all studies, assist with the creation of study documents and will send and track documents to and from the study sites. The CTA will also attend clinical meetings, interact with study sites, run reports, take minutes and assist with other tasks as needed. A minimum of 2 years’ experience in clinical operations is required and experience using Trial Interactive eTMF system is highly preferred.
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OVERVIEW SUMMARY: The Clinical Trial Administrator (CTA) position will provide support in the Clinical Department for all clinical operation activities and will provide direct assistance to the Clinical Department Head. The CTA will maintain the eTMF for all studies, assist with the creation of study documents and will send and track documents to and from the study sites. The CTA will attend clinical meetings, interact with study sites, run reports, take minutes and assist with other tasks as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING:
- Assisting in clinical trial management including management of clinical trial activities and coordination of clinical activities, from start-up to study closure
- Maintaining the electronic Trial Master File (TMF) for all Clinical studies to ensure documents are complete, readable, filed correctly and all required documents are present
- Interacting with sites to obtain necessary documentation and information before, during and after the study. Ensuring accurate inventory of central, investigator site and core files on an ongoing basis to ensure that the files are complete and can be used as a source of reference where dictated.
- Assisting in the creation of case report forms, source documents and all other study forms, templates and documents
- Preparing, sending and tracking study materials and managing trial supplies as needed
- Running reports from the EDC for internal distribution and review listings as needed
- Calculating and tracking site payments
- Attending team meetings and taking minutes
- Assembling initial composition of Investigator Site Files (ISF)
- Creating and maintaining study contact lists for study team and sites
- Assisting with newsletters and sending them to study sites
- Assisting with preparation and presentation at investigator meetings, as required to ensure that the clinical and investigational site staff team are well informed about the study and related procedures
EDUCATION AND/OR EXPERIENCE NEEDED:
- High School diploma required, Bachelor of Science degree preferred
- A minimum of 2 years’ experience in clinical operations at a pharmaceutical, biotech or medical device company
- Experience using an electronic Trial Master File system (eTMF), Trial Interactive preferred
- Experience working with and tracking clinical and regulatory documents
- Experience in a collaborative team environment
- Interpersonal skills that enable the candidate to work with cross functional teams within the company
- Extremely detail orientated with superior organizational skills
- Excellent oral and written communication skills
- Proficiency in MS Office applications
- Ability to work from home or in an office environment
- Strong assessment and decision-making skills with an ability to prioritize critical issues
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