Clinical Research Associate (Dallas, TX)
- Conduct site qualification, initiation, monitoring and closeout visits in accordance with applicable guidelines and client’s SOPs and create documentation of such through accurate and detailed visit reports.
- Monitor source documents to EDC for completeness and accuracy through verification of subject records and source documentation. Verify that all subjects meet inclusion/exclusion criteria
- Review all source records for patient safety and ensure complete documentation of all subject safety events.
- Review regulatory binder to ensure complete, accurate, and up-to-date regulatory compliance at the site.
- Ensure compliance with protocol and overall clinical objectives.
- Train site personnel on study procedures and provide documentation of training. Ensure that study personnel are qualified by experience and training to perform assigned tasks.
- Ensure investigator involvement in the study and IRB/EC oversight.
- Follow-through after visits to see that all outstanding requests/needs are fulfilled.
- Raise issues of significance to the appropriate level for resolution.
- Able to help site navigate informed consent issues and support IRB submission process, as needed.
- Collaborate with Project Managers and cross-functional teams during study start-up and conduct.
- Contribute to the development and review of the Clinical Monitoring Plan, informed consent templates, and other study tools. Lead review of site-level informed consents before and after IRB submission. Work with sites between monitoring visits to ensure Essential Regulatory Documentation is current, collected and filed in client TMF and site ISF.
- Work with sites between monitoring visits to ensure timely data entry and query resolution, and follow-up challenges.
- Ensure sites have submitted relevant source documents related to safety events. Work with coordinators to ensure that safety events are reported in a timely manner, and work with CPM to ensure that all information is available for DSMB reporting.
- Ensure sites are continuing follow-up of subjects in accordance with protocol requirements.
- Proactively identify and support process improvement at study or site level. Work with key stakeholders within the organization and externally to resolve.
- Participate in other activities as needed.
- Minimum of a 4-year Bachelor’s degree, preferably in life sciences field and good familiarity with medical terminology
- Minimum 2 years of field monitoring experience as a Clinical Research Associate required. (In-house CRA or Study Coordinator experience alone does not meet this requirement.)
- Prior experience in neurology clinical trials is strongly preferred
- Proficiency in Microsoft suite of products, including Word, Teams, Excel, and PowerPoint, is required; familiarity with EDC and CTMS systems are also required.
- Ability to foster relationships with clinical sites and colleagues
- Audit experience also preferred.
- Ability to support several projects simultaneously; a flexible working style and attention to detail are essential.
- Able to work independently with excellent time management skills
- Excellent work ethic with desire to be a valuable contributing team member
- Approximately 50% travel that will vary over time, including international travel (able to travel abroad and obtain relevant visas) within US and Canada and as needed to the Europe, Israel and Asia; Ideal candidate will reside in Dallas, TX with easy access to travel options
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