Regional Clinical Research Associate

Job Title: Regional Clinical Research Associate

Job Number: 31997

Location: Remote, 

Job Description

The Clinical Research Associate plays a vital role in the Clinical Operations team. Through responsibilities like monitoring studies, reviewing data, and engaging with sites, the CRA will ensure the success of clinical trial operations and management.

Responsibilities

• Monitoring clinical studies of investigational and approved products that have been determined to satisfy a medical need and/or offer a commercial benefit.  This may include the following site visits: qualification, initiation, interim, and close out
• Managing and training of site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Managing, preparing, sending, tracking, and returning investigational supplies at individual sites
• Monitoring and documenting investigational product dispensing, inventory, and reconciliation
• Monitoring and documenting laboratory sample storage and shipment
• Monitoring trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Reviewing source data and case report forms for accuracy, completeness, and integrity of the data, and identifying and resolving ongoing data issues
• Reviewing data queries and listings, and working with the study centers to resolve data discrepancies
• Reviewing regulatory documentation for accuracy and completeness, and supporting study centers with regulatory issues
• Maintaining complete and accurate study files and reviewing files to ensure all appropriate documentation is present
• Maintaining consistent and timely contact with the study centers, investigators, coordinators, client personnel, and other individuals involved in clinical trials.
• Following Good Documentation Practices, completing Visit Reports and site correspondence in accordance with SOPs

Required Skills

• Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training
• 2+ years of prior experience as a Clinical Research Associate, 4+ years for Senior CRA 
• Site monitoring experience is required