Experienced Study Start-Up Coordinator

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.

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.

SITE ACTIVATION & MAINTENANCE (SAM) TRAINING PROGRAM

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 specializing in study start-up is required;
• Excellent organizational and prioritization skills;
• Knowledge of Microsoft Office; and
• Great attention to detail and excellent oral and written communication skills.

Travel: 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

• Work alongside physicians, scientists, and industry-leading experts committed to advancing the global development of medical therapeutics through clinical research excellence

Collaborative Culture

• Contribute to an interactive team environment that empowers decision making, creative thinking, and continuous learning through open communication and mutual trust.
• Leadership throughout Medpace is both accessible and approachable

Continuous Growth & Development

• Office based environment with on-site mentors
• Defined career paths with clear advancement opportunities
• Industry renowned onboarding and training programs designed to accelerate professional development
• Ongoing training and continuous learning opportunities throughout your career
• An environment that encourages employees to influence change, contribute ideas, and grow quickly

Other Employee 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 and intramural sports

Cincinnati Headquarters Experience

• A modern corporate campus designed to support collaboration and productivity
• Multiple on-site dining options in the heart of Madison Square
• Free on-site parking
• Convenient access to on-site 24-7 fitness and wellness facilities

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.