Job Description:

• Manage and support clinical sites from site approval through close-out
• Develop study documents and tools, including Informed Consent Form (ICF) templates
• Support sites in obtaining IRB approval and developing submission materials
• Respond to sites’ regulatory board requests for protocol and ICF clarification
• Ensure all required site regulatory documents are in place prior to investigational product shipment
• Conduct routine file reviews and analyze site performance problems
• Maintain regular communication with study sites to ensure compliance
• Conduct remote review of data entered on electronic Case Report Forms (eCRFs)
• Assist with efforts to recruit investigative sites to participate in clinical studies
• Comply with ICH GCP guidelines and FDA regulations
• Participate in internal, client/sponsor, scientific, and other meetings as required
• Manage and resolve conflicting priorities to deliver on commitments

Requirements:

• BS/BA from an undergraduate program or equivalent experience
• 1-2 years of experience in clinical research
• Proven ability to be careful, thorough, and detail-oriented
• Strong organizational skills and the ability to multi-task and work effectively in a fast-paced environment
• Strong analytical, negotiation, meeting management, cross-functional team, and leadership skills
• Self-starter who thrives in a collaborative environment
• Strong command of English, both written and verbal
• Excellent communication and interpersonal skills with customer service orientation
• Proficient with MS Office Suite, particularly Word and Excel
• Permanent authorization to work in the U.S.

Benefits:

• Professional development
• Global travel
• Flexible work programs