Study Start-Up Coordinator – Clinical Research Coordinator Experience

Our clinical operations activities are growing rapidly, and we are currently seeking an experienced Study Start-Up Coordinator to join our Regulatory Submissions team in Denver, CO. 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. If you want an exciting career where you build upon the foundation of your previous expertise and can develop and grow your career even further, then this is the opportunity for you. *This position is office-based in Denver, CO.

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 (includes submissions to Institutional Review Boards);

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

A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);

Experience as a Clinical Research Coordinator or industry equivalent (minimum 3 years);

Excellent organizational and prioritization skills;

Experience with Institutional Review Board (IRB) submissions and Informed Consent Form development is required;

Knowledge of Microsoft Office; and

Great attention to detail and excellent oral and written communication skills.

Compensation

A target salary range of $40,000 - $100,000 with potential for bonus awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). Applications will be accepted on an ongoing basis. For more details, please discuss with your recruiter.

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

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.

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 (includes submissions to Institutional Review Boards);

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.

A minimum of a Bachelor's degree is required (preferably in a Life Sciences field);

Experience as a Clinical Research Coordinator or industry equivalent (minimum 3 years);

Excellent organizational and prioritization skills;

Experience with Institutional Review Board (IRB) submissions and Informed Consent Form development is required;

Knowledge of Microsoft Office; and

Great attention to detail and excellent oral and written communication skills.

Compensation

A target salary range of $40,000 - $100,000 with potential for bonus awards. Your compensation will be based on your skills and experience. Medpace offers the following benefits for full-time positions: medical, dental, vision, 401(k), vacation policy, sick days, paid holidays, work from home flexibility, short-term disability, long-term disability, health savings and flexible savings accounts, life and AD&D insurance, pet insurance, and reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations). Applications will be accepted on an ongoing basis. For more details, please discuss with your recruiter.