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Regulatory Research Coordinator - Dallas

Company: Medpace, Inc.
Location: Irving
Posted on: May 13, 2022

Job Description:

Job Summary:Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Clinical Operations team. This position works both independently and collaboratively with a team to meet common goals and plays a key role in the clinical trial management and study start-up process at Medpace. We have openings ranging from entry to senior coordinator to best match your experience level. If you want an exciting career where you use your previous expertise and can develop and grow your career even further, then this is the opportunity for you.Responsibilities :

  • Communicate with research sites (doctor's offices, universities, hospitals, etc.) 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 (includes submissions to Institutional Review Boards, or 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; and
  • Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.
    SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAMMedpace training programs are curated to educate and support experienced associates, as well as those that are new to the industry. The SAM Training Program embraces evidence based learning & development models to advance professional learning and employee performance. In the program, you will---
    • Complete independent learning modules, interactive exercises, and team workshops through the core curriculum;
    • Gain exposure to real-world tasks through a robust mentoring program; and
    • Join other professionals revolutionizing efficient and seamless study start-up to advance clinical trials.Qualifications :
      • Bachelor's degree required, preferably in a Life Sciences field;
      • 2-5+ years of prior experience as a study coordinator or within the pharmaceutical industry, specializing in study start up is required;
      • Excellent organization and communication skills; and
      • Knowledge of Microsoft - Office
        Travel: NoneSupervisor Responsibilities: NoneMedpace 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 4,000 people across almost 40 countries.Why Medpace?:When you join Medpace, you become part of a team dedicated to supporting the development of ground-breaking drugs and devices. Our employees provide hope for those living with debilitating diseases. We invite you to be a part of something that is impacting millions of people around the globe while enjoying a competitive total compensation and benefits package and internal growth opportunities.
        Organic Growth: Medpace is continuing to grow in all areas globally and has built an expansive research campus at its headquarters in Cincinnati, OH. In 2020, Medpace opened a new seven story building that is approximately 250,000 SQFT. In total, the headquarter's campus includes five buildings and approximately 600,000 SQFT. The company also has expanding office locations in Dallas, TX and Denver, CO.
        Perks (vary by location and position):
        • On-site fitness center(s)
        • Campus walking paths
        • Company-sponsored social and wellness events
        • Official Sponsor of FC Cincinnati
        • Hybrid work-from-home options and flexible work schedule
        • On-site Market Place
        • Free and covered parking
        • Discounts for local businesses
        • On campus restaurants and banks coming soon
          • Medpace historically named a Top Cincinnati Workplace by the Cincinnati Enquirer
          • Recognized by Forbes as one of America's Best Mid-size Companies in 2021
          • Medpace ranks amongst top CROs for site ratings across all 10 important attributes including CRA training, preparation & organization, accessibility of staff, open communication, and ensuring timely drug availability
          • Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility
          • Ranked in the top 10 on the 2021 LinkedIn Top Companies list in CincinnatiWhat to Expect Next:A member of our recruitment team will review your qualifications and, if interested, you will be contacted for an interview.
            EO/AA Employer M/F/Disability/Vets

Keywords: Medpace, Inc., Irving , Regulatory Research Coordinator - Dallas, Other , Irving, Texas

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