CRA Candidate Responsibilities
- Perform site management including tracking of essential clinical trial documentation, training of site staff on study procedures, and monitoring of site adherence to protocol specified procedures. Must use detailed knowledge of assigned protocol(s) and Manual of Operations to ensure quality and deliverables are met across sites.
- Conduct initial review of adverse event reports for completeness prior to sending to regulatory groups and/or adjudication committees for detailed review as needed.
- Monitor recruitment and data quality while on site and remotely through EDC systems and direct site communication.
- Communicate with central laboratories/vendors on an ongoing basis to address and resolve issues.
- Collaborate with study team to develop standard procedures and data collection forms, and site training materials.
CRA Skills and Experience
- BS or RN and 3 years of clinical experience, some of which includes site monitoring experience or BS or RN and 3 – 4 years of site coordination experience on multiple clinical studies or protocols.
- Demonstrated core understanding of medical terminology, medical records and clinical trial activities.
- Must have working knowledge of ICH-GCP guidelines, and FDA regulation as a result of clinical research experience.
- Ability to monitor and coordinate multi-site research trials.
- Excellent communication, interpersonal, decision making/problem solving and organizational skills.
- Ability to work independently to initiate and implement appropriate quality control procedures.
- Proficiency with Microsoft Office Products and electronic data capture (EDC) systems.
- SOCRA or ACRP certificate is helpful, but not required.