Background

TrialSpark is a technology company that brings new treatments to patients faster by reimagining the clinical trial process. Today, a clinical trial can cost more than $100M and take 10 years to complete, bottlenecking the development of new treatments for patients. We’re fundamentally changing how trials are run, rethinking the trial process both from a technology and operational perspective.

Job Description

The Clinical Document Specialist is responsible for supporting Trial Master File (TMF) set-up, maintenance, closure, and transfer for clinical projects at TrialSpark. This role will also act as the superuser and administrator for the eTMF platform that TrialSpark uses. This position reports to the Director, Study Operations and will be expected to perform duties and responsibilities with minimal supervision. 

This individual will need to have awareness of applicable clinical research regulatory requirements - ICH GCP, along with familiarity with the documents used in clinical trials at both the TMF and ISF level. You should be able to demonstrate a willingness to work in a fast-paced environment juggling workload with time pressures. The ability to establish and maintain effective working relationships with coworkers, managers, and clients is key and you should have good written and verbal communication skills as well as working knowledge of computer applications such as Word, Excel, and PowerPoint.

Responsibilities:

• Process clinical study documentation in accordance with SOPs, FDA, and ICH GCP guidelines.
• Perform quality-control (QC) review of clinical and regulatory documents submitted for entry into the TMF and liaise with project teams to resolve any issues identified with the documents submitted.
• Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance.
• Administrate user access for the eTMF software and maintain access documentation.
• Provide support and training to team members on processes and eTMF software.
• Assist the clinical team in the close-out and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. 
• Process and fulfill document requests from external stakeholders for studies which have been archived in the eTMF/eISF.
• Assist with periodic review of study files for completeness.

Relevant Experience and Skills

• Minimum 2 years’ experience as a Clinical Trial Assistant (or comparable operating experience) in medical device, pharma/biotech, CRO - preferable, or healthcare environment(s) required.
• Two years of demonstrable records management experience, specifically eTMF (Veeva, Montrium, Master Control, Documentum, Box) experience in the clinical research field.
• Understanding and knowledge of current industry regulations and guidelines.
• Familiarity with ICH GCP, DIA TMF Reference Model and regulatory guidelines/directives.
• Familiarity with eTMF and CTMS software for document management activities preferred.
• Ability to learn and apply SOPs and process governance regulations pertaining to clinical study documentation.
• Strong organizational/communication skills and attention to detail.
• Expertise in Microsoft Office Suite and Adobe Acrobat.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.