Study Start-Up Coordinator- PhD

Medpace; Cincinnati (OH); On-site; USD 50,000 - 70,000; Full time

Benefits offered by this job

Flexible work environment

Competitive PTO packages, starting at 20+ days

Modern, ecofriendly campus with an on-site fitness center

Discounted tuition for UC online programs

Employee health and wellness initiatives

Job summary

Medpace, a leading clinical contract research organization, is seeking full-time Regulatory Submissions Coordinators in Cincinnati. This role is essential for managing clinical trial documentation and requires a PhD in Life Sciences. With ample training and development opportunities, this position is perfect for entry-level candidates looking to grow their careers in the clinical research field.

Qualifications

• Minimum of PhD is required.
• 3.5 GPA and above preferred.
• Some experience in an office setting is preferred.

Responsibilities

• Communicate with research sites to collect essential documents.
• Maintain quality review of trial documents in the TMF.
• Collect and organize regulatory start-up submissions.

Skills

Organizational skills

Attention to detail

Communication skills

Education

PhD in Life Sciences

Tools

Microsoft Office

Job description

Job Summary

Our clinical operations activities are growing rapidly, and we are currently seeking 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 are seeking entry level employees. If you want an exciting career where you can build a foundation in industry knowledge through our robust training program and 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; 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

• A minimum of a PhD is required (preferably in a Life Sciences field);
• 3.5 GPA and above preferred;
• Some experience in an office setting is preferred;
• 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). 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 5,000 people across 40+ countries.

Why Medpace?

People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today.

The work we’ve done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future.

Cincinnati Perks

• Cincinnati Campus Overview
• Flexible work environment
• Competitive PTO packages, starting at 20+ days
• Competitive compensation and benefits package
• Company-sponsored employee appreciation events
• Employee health and wellness initiatives
• Community involvement with local nonprofit organizations
• Discounts on local sports games, fitness gyms and attractions
• Modern, ecofriendly campus with an on-site fitness center
• Structured career paths with opportunities for professional growth
• Discounted tuition for UC online programs

Awards

• Named a Top Workplace in 2024 by The Cincinnati Enquirer

• Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024
• Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility

What to Expect Next

A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.