Clinical Research Associate
Our client is looking for a highly qualified and skilled professional for the role of Clinical Research Associate in Orange County, CA. We are looking for a CRA with knowledge of FDA regulations for clinical trials and clinical procedures, preparing technical documentation (including study protocols, informed consents, case report forms, and study training documents) and the ability to support budgets and contract negotiations with clinical sites.
• Work with a central IRB and sites to ensure IRB approvals.
• Participate in data review, as necessary.
• Managing the conduct of clinical studies in accordance with federal regulations and good clinical practices guidelines.
• Reviewing and reconciling site documentation, including site regulatory documents and patient medical records.
• Interfacing with site staff, monitors, vendors, and/or CROs to execute operational activities.
• Supporting audit activities.
• Support budget and contract negotiations with clinical sites.
• Perform site qualification and selection process.
• Coordinate and participate in investigator meetings and site initiation visits, as well as conducting training of site staff.
• Develop and maintain trackers to support the management of clinical studies.
• Other duties as assigned.
• Demonstrated knowledge of clinical procedures in accordance with the Code of FDA regulations.
• Creative problem solving; keen attention to details; outstanding organizational abilities.
• Strong collaborative skills with demonstrated ability to work with physicians, site coordinators and others within the company.
• High level of clinical expertise in various therapeutic areas and procedures associated with clinical research projects.
• Experience working in an FDA-regulated industry and conduct of clinical trials.
• Excellent written and oral communication skills.
• Field Monitor experience a plus.
• Clinical Trial Management System (CTMS) experience.
• Experience with audit inspections.
• Motivated individual with a high-energy level.
• Certified Clinical Research Associate (CCRA) certification.
• Bachelor’s degree in related field or equivalent experience (Life Science degree preferred).