Regional CRA Job in Santa Ana, California US

Regional CRA

Regional CRA Job Description: A local CRO is interviewing for PERMANENT Clinical Research Associates (CRAs) for Regional Monitoring in California. Salary will range from $65-90k based on experience, with a $5,000 signing bonus for candidates starting in Q1, and 4 weeks of vacation in the first year. Regional - California Monitors the progress of clinical studies at investigative sites, and ensures that clinical studies are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements. ACCOUNTABILITIES - Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH guidelines o Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the proper conduct of studies, to review data and ensure accuracy of data collected and to terminate studies o Provides regular clinical status information to team members and project management o Performs billable work in accordance with Company policies, procedures, and Standard Operating Procedures o Works closely with other team members to ensure timely resolution of project and/or clinical issues and obtains direction from more senior clinical operations staff. o Communicates common site trends to Lead CRA and other project team members - Performs investigative site file reconciliation; requests any new or updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements, ICH guidelines, project Standard Operating Procedures (SOPs), and sponsor requirements o Performs source document verification, retrieves Case Report Forms (CRFs) and performs query resolution in a timely manner and oversees drug accountability and safety at investigative sites o Ensures Serious Adverse Event (SAE) reporting according to project specifications o Responds to requests from investigative sites in a timely fashion - Mentors junior level CRAs and serves as a resource for new employees - May serve as a resource for and interact with other functional areas to resolve site issues and facilitate project timelines - If assigned direct reports: Schedules and reviews project tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with PRA's policies, procedures, and SOPs, and ensures HR processes are properly implemented - May be assigned Lead CRA accountabilities on non-global studies QUALIFICATIONS - Undergraduate degree in a clinical, scientific, or related field or its international equivalent, or equivalent work experience required - An advanced degree (e.g., M.S., M.B.A., PharmD, etc) preferred Minimum of 18 months field monitoring experience at a CRO, pharma or biotech company required Therapeutic experience in oncology, CNS or Infectious Disease required - Read, write and speak fluent English; fluent in host country language - Experience using computerized information systems, electronic spreadsheets, word processing and electronic mail preferred - Knowledge of ICH and local regulatory authority regulations regarding drug research and development Required Skills for Regional CRA Job: CLINICAL RESEARCH MONITOR CLINICAL REGULATORY EDC TMF About Aerotek Scientific: Join Aerotek Scientific 74 LLC, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers and will consider all applications without regard to race, marital status, sex, age, color, religion, national origin, veteran status, disability or any other characteristic protected by law. Additional Info Minimum Age 18+ years old Job Industries Healthcare