Senior CRA

Job Title: Senior CRA

Job Number: 32000

Location: Remote, 

Job Description

The Senior Clinical Research Associate (Sr. CRA) plays an integral part in the successful monitoring and management of clinical trials. Responsibilities of a Sr. CRA include ensuring clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH GCP, and all applicable regulatory requirements. Sr. CRAs may be required to travel up to 65%

Responsibilities

• Monitor 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
• Manage and train site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion
• Manage and track the preparation and return of investigational supplies at individual sites
• Monitor and document investigational product dispensing, inventory, and reconciliation
• Monitor and document laboratory sample storage and shipment
• Monitor trial by reviewing and reporting on the following: site enrollment and termination updates, monitoring visits, protocol deviations/exceptions, serious adverse events, and laboratory abnormalities
• Review source data and case report forms for accuracy, completeness, and integrity of the data, and identify and resolve ongoing data issues
• Review data queries and listings, and work with study centers to resolve data discrepancies
• Review regulatory documentation for accuracy and completeness, and support study centers with regulatory issues

Required Skills

• RN or Bachelor and/or advanced degree in biological sciences or related field, or equivalent combination of relevant experience, education or training, and previous CRA experience demonstrating career growth in the CRA position