Medpace ยท 1 day ago
Experienced Study Start-Up Research Coordinator - Denver
Denver, CO
Full-time
Onsite
Mid Level
$40K/yr - $100K/yr
3+ years expMedpace is a full-service clinical contract research organization (CRO) that provides Phase I-IV clinical development services. They are seeking an Experienced Study Start-Up Research Coordinator to join their Study Start-up team, where the role involves managing regulatory submissions and ensuring compliance with regulations throughout the clinical trial process.
BiotechnologyPharmaceutical
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
Qualification
Required
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
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
Company
Medpace
Medpace, Inc., a clinical research organization, provides clinical development services for pharmaceutical and biotechnology
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
unknown2016-08-10IPO
2014-02-24Acquired
Leadership Team
J
Jesse Geige
President
Recent News
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