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Regulatory Associate

| Greater NYC Area

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.

TrialSpark’s business lines:

In short, TrialSpark works with our Biotech and Pharma partners in 3 ways: 1) we provide standalone digital advertising-based patient recruitment services, 2) we operate trial sites in support of phase II-IV clinical trials, and 3) we run end-to-end Phase II studies as an alternative to a Contract Research Organization (CRO).

Job Description

The Clinical Research Regulatory Associate will manage regulatory activity for clinical research trials TrialSpark is engaged on. They will oversee ensuring our studies meet regulatory requirements at the federal and state level, including supporting study and site startup, reporting, and closeout submissions to Institutional Review Boards (IRB) and relevant regulatory agencies and sponsors. 

Given the importance of sound regulatory execution in ensuring patient safety, quality, and compliance, this team member must have impeccable judgement, a strong work ethic, and high ethical standards. 

Responsibilities

  • Maintain a working understanding of Food and Drug Administration (FDA), International Conference on Harmonization (ICH), Code of Federal Regulations (CFR), and Good Clinical Practice (GCP) policies and guidelines as they relate to the conduct of human clinical trials.
  • Understanding of the research protocols and the ability to translate research requirements into appropriate regulatory actions.
  • Preparation and maintenance of all regulatory matters, including site-level essential documents (ICFs, CVs, licenses, etc.), IRB submissions, and governmental regulatory documents (e.g., FDA 1572s). 
  • Partner closely with Clinical Operations, QA, and other functions to weave regulatory excellence into our organization.
  • Support of study and site start-up regulatory activities, ongoing IRB continuing reviews, modifications, and study closeout regulatory documents. 
  • Supporting Training team in education for Clinical Research staff on regulatory standards.
  • Managing archiving of clinical trial documents and records, in accordance with government and sponsor standards. 
  • Responsible for overall management of electronic Investigator Site File (eISF) solution, including overseeing KPIs on completeness and timeliness of key regulatory documents.
  • Preparation for internal and external inspections, audits and monitoring visits, including partnering with the QA team and clinical research coordinators to prepare regulatory binders and documents.

Requirements

  • Bachelor’s degree (B.S. preferred)
  • Minimum of 3 years experience in clinical research space, as a regulatory specialist, eTMF administrator, CRC, CRA, or related role; prior regulatory-focused experience preferred.
  • Hard-working self-starter that can thrive in an ambiguous environment. 
  • Preferred experience managing regulatory across a multi-site environment, including experience with digital ISF / CTMS / eTMF solutions.
  • An earnest desire to improve the way clinical trials are run and bring new treatments to patients in need.

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

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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