Job Description
The Clinical Research Associate (CRA) position represents an opportunity to grow within an emerging medical device company. Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP)/ICH, and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical. The CRA has broad exposure to clinical research tasks as a combination of in-house and field work.
Monitoring Responsibilities: - 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.
Site Management & Study Support Responsibilities
- 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.
Qualifications:
- 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
Job Tags
Full time, Flexible hours,