Study Start-Up Coordinator Clinical Research Coordinator Experience

Regulatory Submissions Coordinator

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinator to join our Study Start-up 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 for clinical research coordinators to best match your experience level. If you want to build on your foundational knowledge and your previous experience to develop and grow your career even further, then this is the opportunity for you. This position is based in Dallas, TX.

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 (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.

Medpace 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; 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 Travel: None Supervisor Responsibilities: None

Medpace Overview

Medpace is a full-service clinical contract research organization (CRO) providing phase l-lV 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 the advancement of clinical research. We leverage in-country regulatory and therapeutic expertise across all major therapeutic areas including oncology, cardiology, metabolic, endocrinology, central nervous system, and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, we employ more than 6,500 people across 40+ countries.

Why Medpace?

When you join Medpace, you become part of an innovative team that brings cutting-edge therapies to market while building a meaningful and rewarding career focused on scientific excellence and improving patient outcomes around the world through continuous learning and cross-functional collaboration.

Purpose-Driven Work

Collaborative Culture

Continuous Growth & Development

Other Employee Benefits

Please note benefits may vary based on country.

What to Expect Next

A Medpace team member will review your application and if your profile matches our current needs, you will be contacted for an interview. While we review all applications carefully, we are unable to respond to every applicant, and only candidates selected for interviews will be contacted.