Experienced Study Start-Up Research Coordinator - Denver

Medpace, Inc.•Denver, CO

4d•$40,000 - $100,000•Onsite

About The Position

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. 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.

Requirements

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
Great attention to detail and excellent oral and written communication skills

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

Benefits

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
reimbursement for travel expenses (including food and gas allowance, rental cars, and hotel accommodations)
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
Structured career paths with opportunities for professional growth
Discounts on local sports games, fitness gyms and attractions
Modern, ecofriendly campus with an on-site fitness center
RTD Eco Pass
Secure bike storage room