Study Start-Up Coordinator – Clinical Research Coordinator Experience

Medpace, Inc. • Irving, TX

121d • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• study start-up experience preferred

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; and
• Review pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

Benefits

• Competitive compensation programs that recognize and reward performance
• Comprehensive health, wellness, retirement, and PTO benefits
• Office based culture with occasional WFH that provides flexibility for eligible positions after training
• Company-sponsored social events

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level