Initiation Clinical Research Associate - iCRA
Core
Lead and execute study start-up, pre-site initiation visit, site activation, and protocol amendment activities from site identification through activation and maintenance.
Role type
Initiation Clinical Research Associate (iCRA)
Builds
Clinical trial start-up and site activation for biopharmaceutical sponsors
Domain
Life Sciences / Clinical Research
Required skills
Clinical trial management systems, Electronic Trial Master File (eTMF), Trial Master File (TMF), Regulatory submissions, Site feasibility and qualification, Protocol amendments, ICH-GCP guidelines, Microsoft Office
Preferred skills
Life Sciences, Pharmacy, Nursing, Health-related field
Technologies
Clinical trial management systems, eTMF, TMF, Microsoft Office
Responsibilities
Manage site start-up activities from feasibility and qualification through site activation. Prepare, review, negotiate, and execute regulatory and site documents. Coordinate submissions and approvals with IRBs, IECs, Ministries of Health, and Regulatory Authorities. Develop and track site activation strategies, timelines, and regulatory plans. Maintain accurate, high-quality documentation in clinical trial management and eTMF systems. Identify, resolve, or escalate site issues and risks related to activation, recruitment, compliance, training, and data quality. Support sites with study system access, training requirements, and readiness activities. Ensure assigned sites remain audit-ready and inspection-ready throughout the study lifecycle.
Seniority
Mid-level, hands-on IC
