Clinical Research Associate Job Description

by Publisher, eResumes4Vips
(Texas, USA)

Clinical Research Associate Job Description

Job Description:
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.

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.

Provides regular clinical status information to team members and project management.

Performs billable work in accordance with PRA 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

Mentors junior level CRAs and serves as a resource for new employees.