Study Start-Up Coordinator- Clinical Research Coordinator Experience

Medpace; Cincinnati (OH); On-site; USD 65,000 - 90,000; Full time

Job summary

Medpace is a Cincinnati-based global CRO seeking a full-time Regulatory Submissions Coordinator to join our Study Start-up team. This office-based role collaborates with sites and internal teams to manage regulatory start-up submissions and TMF quality.

You will collect documents from research sites, maintain timelines, and ensure compliance with IRB and regulatory requirements. A Life Sciences degree and 1–5+ years of start-up experience are preferred.

Qualifications

• Bachelor's degree required (preferably in Life Sciences).
• 1–5+ years of experience as a study coordinator or within pharmaceutical study start-up.
• Excellent organizational and prioritization skills.
• Knowledge of Microsoft Office.
• Great attention to detail and excellent oral and written communication skills.

Responsibilities

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

Skills

Communication skills

Organizational skills

Attention to detail

Education

Bachelor's degree (Life Sciences preferred)

Tools

Microsoft Office

Job description

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking a full-time, office-based Regulatory Submissions Coordinators 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, or PharmD or PhD 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