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 & take 10 years to complete, bottlenecking the development of new treatments for patients. Were fundamentally changing how trials are run, rethinking the trial process both from a technology & operational perspective.
The Clinical Document Specialist is responsible for supporting Trial Master File (TMF) set-up, maintenance, closure, & transfer for clinical projects at TrialSpark. This role will also act as the superuser & administrator for the eTMF platform that TrialSpark uses. This position reports to the Director, Study Operations & will be expected to perform duties & 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 & 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 & maintain effective working relationships with coworkers, managers, & clients is key & you should have good written & verbal communication skills as well as working knowledge of computer applications such as Word, Excel, & PowerPoint.
- Process clinical study documentation in accordance with SOPs, FDA, & ICH GCP guidelines.
- Perform quality-control (QC) review of clinical & regulatory documents submitted for entry into the TMF & liaise with project teams to resolve any issues identified with the documents submitted.
- Assist with the development of work processes & systems to support document management, including contributing to SOPs & internal department guidance.
- Administrate user access for the eTMF software & maintain access documentation.
- Provide support & training to team members on processes & eTMF software.
- Assist the clinical team in the close-out & archiving of clinical documentation & reports according to the scope of work & standard operating procedures.
- Process & fulfill document requests from external stakeholders for studies which have been archived in the eTMF/eISF.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 & 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 & knowledge of current industry regulations & guidelines.
- Familiarity with ICH GCP, DIA TMF Reference Model & regulatory guidelines/directives.
- Familiarity with eTMF & CTMS software for document management activities preferred.
- Ability to learn & apply SOPs & process governance regulations pertaining to clinical study documentation.
- Strong organizational/communication skills & attention to detail.
- Expertise in Microsoft Office Suite & 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.