Job Title: Clinical Research Associate
Job Number: 31997
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.
- 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
- 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 preferred
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