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, developing submission materials, and creating site-specific ICFs
Ensure all required site regulatory documents and approvals are in place prior to investigational product shipment
Conduct routine file reviews and ensure all regulatory documents are collected and filed appropriately
Analyze site performance problems and identify solutions; provide ongoing training for study sites
Conduct remote review of data entered on electronic Case Report Forms (eCRFs) as needed
Maintain regular communication with study sites to ensure protocol/GCP compliance
Conduct internal, client/sponsor, scientific, and other meetings as required
Perform additional duties as assigned

Requirements

BS/BA from an undergraduate program or equivalent experience
At least 7 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, yet less structured team environment
Ability to problem-solve unstructured or ambiguous challenges
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

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchregulatory document managementInformed Consent Form (ICF) developmentIRB approval processdata analysiselectronic Case Report Forms (eCRFs)protocol complianceGCP compliance

Soft Skills

detail-orientedorganizational skillsmulti-taskinganalytical skillsnegotiation skillsmeeting managementleadership skillsproblem-solvingcommunication skillsinterpersonal skills