Experienced Study Start-Up Research Coordinator

Medpace, Inc. • Denver, CO

6d • 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.

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; and
• 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; and
• 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)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level