Clinical Research Associate (CA)
One of our sponsor clients is looking for a perm CRA to join their fast paced, dynamic team. They are looking for someone with at least 2 years' experience monitoring. There is a lot of room to grow and minimal travel (25% on average). This client is considering CRA II and Sr CRA level candidates.
- Act as the "Site Manager" ensuring relationship with site(s) are positive, issues are resolved quickly, and communications are strong across all verticals.
- Assist with the development of study manuals, CRFs, monitoring standards, site study tools and other study materials as required.
- Develop and implement site recruitment, selection and initiation plan.
- Manage and drive patient recruitment and enrollment tracking.
- Provide training to sites on the study protocol, study conduct, CRF completion and data management expectations.
- Ensure essential document collection for completeness per regulatory requirements.
- Serve as a liaison with Investigators, Institutions and sites to provide support during the conduct of the clinical trial and serve as a resource for protocol and procedures.
- Demonstrate knowledge of on-site monitoring to ensure compliance with GCPs, study protocols, and SOPs.
Manage one or multiple studies.
- Monitor product supplies/accountability including proper storage, dispensation, and disposal.
- Manage study completion activities including CRF collection, query resolution, record archiving and site closeout activities.
- Review in-house data and study tables.
- Mentor, coach and provide guidance to clinical staff as appropriate.
- Supervise and train other employees as appropriate.
- You will need to go into the office in Aliso Viejo CA for 3 days a week and will have one site in CA
- Must be well-versed in documentation and regulatory
- Having experience monitoring Device studies is preferred
- Bachelor's Degree Required
- A Nursing or Medical Background or a Master's Degree in a Life Science is a plus
- Being technologically savvy is a plus - currently on a TMF but will be on eTMF in the future so knowing the nomenclature for TMFs would be good