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. To be successful in this role, CRA's must perform 8 Site Visits and/or 10 days out on site per month. This may require up to 75-80% Travel.
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
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
Provides regular clinical status information to team members and project management
Performs billable work in accordance with client policies, procedures, and Standard Operating Procedures
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.
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
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
Ensures Serious Adverse Event (SAE) reporting according to project specifications
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 client’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
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
