In House Clinical Research Associate

Remote role Full-time Open position

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:

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