Clinical Document Specialist at TrialSpark

| Greater NYC Area
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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  • Process and fulfill document requests from external stakeholders for studies which have been archived in the eTMF/eISF.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.

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Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • ReactLibraries
    • ReduxLibraries
    • FlaskFrameworks
    • PostgreSQLDatabases

Location

Our office is located in the Flatiron District of NYC, near Madison Square Park. The area is lively and has great food and transportation options!

An Insider's view of TrialSpark

What are some social events your company does?

We believe in healthy living! We organize regular team exercise classes as a company!

Frank Wu

Product Manager

How do you empower your team to be more creative?

We believe in presenting problems, not solutions, to the team. Our job is to align the team on company goals and issues, and allow the team to work creatively to solve them. We believe team autonomy fosters creativity and a healthier culture.

Linhao Zhang

CTO

What are TrialSpark Perks + Benefits

TrialSpark Benefits Overview

Trialspark is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
We have a monthly transportation subsidy!
Company Outings
Yearly retreat and holiday party, regular team events and outings!
Free Daily Meals
We offer free lunch every day except Wednesday (when we encourage employees to leave the office and explore the area!)
Game Room
Super Smash Club every Friday!
Stocked Kitchen
Happy Hours
Pet Friendly
Come meet our office dog, Rosie!
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
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