Clinical Research Associate

Skills:

Clinical Site Monitoring, Clinical Trials Monitoring, Clinical Trials Operations

Experience:

5+ years of related experience

This is a hybrid position and will report onsite 1-2 days a week rick in Frederick, Maryland. Must reside within commuting distance.

• Develop a Clinical Monitoring Plan and monitor single site and multicenter clinical studies both inside and outside the continental United States; when required, conduct centralized monitoring activities.
• Remote review of electronic source documents, electronic Case Report Forms (CRFs), trends, and metrics in order to identify and mitigate safety and data quality risk issue(s), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file. The monitoring reports shall include the date of activities, description of the activities, and any findings from the activities-Prepare protocol deviations and violation and non-compliance reports
• Provide remote evaluation of the study data, carried out by a team including central monitors, medical reviewers at a location other than the sites at which the clinical investigation is being conducted and annotate in monitoring reports for the sponsor’s regulatory file.
• Prepare/review calibration and maintenance records, which are records kept at the clinical site that document the calibration and maintenance of all applicable equipment utilized during the execution of the clinical trial including laboratory equipment, and ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file.
• Prepare and/or review shipment records, which include shipping documentation for investigation products, biological samples, and if applicable, other study supplies provided to the clinical sites.
• Prepare and/or review laboratory sample analysis reports

• Experience reviewing electronic source documents, electronic Case Report Forms (CRFs), prepare Clinical Monitoring Reports and file in the sponsor’s regulatory file.
• Experience providing remote evaluation of the study data
• Experience preparing/reviewing calibration and maintenance records to ensure equipment is adequate, current, accessible and annotate this information in monitoring reports for the sponsor’s regulatory file.
• Experience preparing and/or reviewing shipment records, documentation for investigation products, biological samples, and other study supplies provided to the clinical sites.
• Must be a US Citizen with the ability to obtain a favorable NACI T1 security investigation prior to start date.

• Bachelors degree, 4+ year’s experience supporting clinical research

• 5+ years of experience supporting clinical monitoring

• Clinical trial Monitoring, Clinical Trial Monitoring Plans, Monitoring Visits, Site visit reports

• NACI T1

• Clinical Trial Monitoring support
• Experience in a military research environment