CRA II - SCRA I

CRA II - SCRA I role performing site qualification, initiation, interim monitoring, site management and close-out visits (on-site or remote) with a focus on regulatory, ICH-GCP and GPP compliance. Responsibilities include evaluating site performance, communicating issues and developing action plans; ensuring informed consent is properly documented; protecting subject confidentiality and data integrity; conducting source data review of site documents and medical records; managing data queries and reconciliation; supervising IP inventory and labeling per protocol; ensuring ISF and TMF alignment; supporting patient recruitment and retention; traveling as required (up to 75%); and collaborating with sponsor teams to ensure audit readiness and regulatory compliance. Qualifications emphasize knowledge of ICH/GCP guidelines, computer skills, strong communication, and ability to adapt to changing priorities. The role may involve real world late phase study designs and requires a Bachelor’s degree or RN in a related field or equivalent experience; US deployment considerations and global responsibilities are noted within the job description.