GCP Auditor

| Greater NYC Area
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

Background

TrialSpark is a technology company that brings new medical 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.

Our company is using software and technology to streamline all aspects of a clinical trial. By reducing the time and cost it takes to run a clinical trial, we empower more treatments to be ultimately brought to patients.

Job Description

The GCP Auditor serves as an in-house expert on audit-related matters, maintaining an up-to-date awareness of internal programs and external trends. The GCP Auditor will perform a broad range of audit-related duties (e.g., planning audits, performing audits, ensuring follow-up on findings, providing formal reports, and collaborating with colleagues as needed across various clinical development functional areas such as Data Management, Clinical Project Management, Supplier Management and Oversight etc).

The GCP Auditor may be involved in risk planning for the audit/inspection program. This role leads audits of all types (vendor qualification, internal process, mock audits/inspections) and participates in audits/inspections of all types. The GCP Auditor provides consultation and advice and is involved in the training and mentoring staff. This role may lead development of processes, procedures, tools and training materials.

This role reports into TrialSpark's Head of Quality Assurance.

Duties include but are not limited to:

  • Contributing to the development of the company annual GxP audit plan.
  • Planning and conducting GCP audits in the Drug Development/Clinical Development realm. Audits may include vendor qualification, sponsor, process, computer system qualification, quality assurance/quality management and investigator site. 
  • Reporting Observations and other potential concerns to the auditees and client, both through verbal presentations and written audit reports as required by the client.
  • Assisting with the development of corrective and preventive action plans, and facilitate resolution of audit findings as required.
  • Writing confirmation letters, and audit plans, agendas, reports and other required audit documentation.
  • Providing GCP and inspectional preparedness training to internal team, vendors, and sponsors as required.
  • Support regulatory agency inspections and lead the audit and inspection readiness program across the organization. 
  • Serves as primary liaison with Regulatory Affairs Dept in maintaining an awareness of ongoing regulatory changes

About You: 

  • Bachelor's Degree (or higher) in a life sciences discipline or related field
  •  5 years of experience doing GxP auditing within the Pharma/CRO industry
    • Ideally 3+ years conducting GCP auditors of clinical investigators, vendors, systems or documents
  • A minimum 2 years experience in SOP development and GxP training
  • Comprehensive knowledge of regulatory requirements in the responsible area of auditing (GCP, PV, Computer System Validation, etc.).
  • Comprehensive understanding of ICH Guidelines [i.e., ICH E6 (R1) and ICH E6 (R2)], appropriate EU Directives, appropriate Titles within 21 CFR, and relevant country-specific regulations.
  • You're able to thrive in autonomy and work well with cross functional groups
  • Experience with software tools used in clinical development

Travel:

  • This position may require minimally 40% travel for conducting audits across the TrialSpark network and vendors.

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.

Read Full Job Description
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

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
More Jobs at TrialSpark20 open jobs
All Jobs
Data + Analytics
Dev + Engineer
Marketing
Operations
Project Mgmt
Sales
Operations
new
New York
Sales
new
New York
Data + Analytics
new
New York
Operations
new
New York
Data + Analytics
new
New York
Developer
new
New York
Data + Analytics
new
New York
Marketing
new
New York
Developer
new
New York
Data + Analytics
new
New York
Sales
new
New York
Project Mgmt
new
New York
Operations
new
New York
Data + Analytics
new
New York
Operations
new
New York
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.
Save jobView TrialSpark's full profileSee more TrialSpark jobs