Jobs · Analyst · Texas

Study Start-Up Coordinator – Clinical Research Coordinator Experience

Medpace · Irving, TX · 1 mo ago
On-siteAnalystFull-time

Responsibilities

  • Communicate with research sites to collect all essential documents required before the site begins to screen patients to participate in the clinical trial.
  • Maintain and perform ongoing quality review of trial documents within the Trial Master File (TMF).
  • Collect, review, organize, and assemble regulatory start-up submissions (including submissions to Institutional Review Boards (IRB)).
  • Maintain timelines for study start-up through both internal and external collaboration.
  • Provide advice and guidance to internal and external team members to ensure compliance with applicable regulations and requirements.
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

Qualifications

  • Bachelor's degree required, preferably in a Life Sciences field.
  • 1-5+ years of prior experience as a study coordinator or within the pharmaceutical industry, study start-up experience preferred.
  • Excellent organization and communication skills.
  • Knowledge of Microsoft® Office.

Skills

  • Strong organizational and communication skills.
  • Ability to manage multiple projects simultaneously.
  • Understanding of regulatory requirements and processes.

Benefits

  • Competitive PTO packages, starting at 20+ days.
  • Competitive compensation and benefits package.
  • Company-sponsored employee appreciation events.
  • Employee health and wellness initiatives.
  • Community involvement with nonprofit organizations.
  • Structured career paths with opportunities for professional growth.
  • Discounts on local sports games, fitness gyms and attractions.
  • Modern, ecofriendly campus with an on-site fitness center.
  • Free on-site parking.
  • Outdoor seating and workspace.

Pay

Details will be provided upon further consideration.

Schedule

Details will be provided upon further consideration.

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 6,000 people across 40+ countries.

Dallas Perks

  • Flexible work environment.
  • Competitive PTO packages, starting at 20+ days.
  • Competitive compensation and benefits package.
  • Company-sponsored employee appreciation events.
  • Employee health and wellness initiatives.
  • Community involvement with nonprofit organizations.
  • Structured career paths with opportunities for professional growth.
  • Discounts on local sports games, fitness gyms and attractions.
  • Modern, ecofriendly campus with an on-site fitness center.
  • Free on-site parking.
  • Outdoor seating and workspace.

Why Medpace?

  • People. Purpose. Passion.
  • Make a Difference Tomorrow. Join Us Today.

Next Steps

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.

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