Clinical Research Associate (CRA) / CRA Manager
A minimum of 5 years’ experience as a Clinical Research Associate or an equivalent position, with particular skills and knowledge working on clinical trials following FDA/ICH guidelines. Must have experience as a field-based monitor.
This position is an in-house position with an up to 50% travel component. This position will help manage a team of field-based contract CRAs for a multi-site study and will be the primary field CRA for some clinical sites. This position reports to the Sr. Director of Clinical Affairs.
Essential Duties and Responsibilities:
- Serve as liaison with participating clinical research sites, including, but not limited to, physician investigators, research nurses, and study coordinators
- Conduct on-site and remote monitoring as needed
- Oversee scheduling and compliance to Monitoring Plan with the field CRA team
- Review field CRA monitoring reports and report trends, problems, and solutions to study team
- Triage and escalate clinical study issues as needed
- Support clinical research study start-up activities, including training material development, delivery, and documentation
- Function as a resource for trial sites for all study-related issues, including site-related problem identification and corrective/preventive solution development.
- Train site personnel on study activities including investigational product usage, maintenance and accountability, sample collection, data entry and query resolution
- Oversight of Trial Master File and Essential Documents. Experience with electronic Trial Master Files preferred.
- Have a strong understanding of FDA guidelines regarding clinical trials to include GCP and ICH guidelines.
- Excellent and demonstrated oral and written communications.
- Device experience preferred
To apply for this position, please send your resume to email@example.com.