Manage and support clinical sites from site approval through close-out
Develops study documents and tools, including Informed Consent Form (ICF) templates
Supports sites in obtaining IRB approval, developing submission materials, and creating site-specific ICFs
Responds to sites’ regulatory board requests for protocol and ICF clarification as needed
Ensures all required site regulatory documents and approvals are in place prior to investigational product shipment
Analyzes site performance problems (protocol adherence) and identifies solutions
Maintains regular communication with study sites to ensure protocol/GCP compliance
Conducts remote review of data entered on electronic Case Report Forms (eCRFs)
Assists with efforts to recruit investigative sites to participate in clinical studies
Complies with ICH GCP guidelines, FDA regulations, and company SOPs

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 skills
Self-starter who thrives in a collaborative, yet less structured team 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.

In-House Clinical Research Associate

Key skills