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Trialspark // accelerating discovery of new drugs
 
New York    Posted: Thursday, February 06, 2020
 
   
 
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JOB DETAILS
 

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 & 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.

Job Description

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.

Responsibilities:

  • 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.

 
 
 
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