We are looking for a talented Clinical Research Associate to joining an awesome Biotech company in San Diego, CA!
SUMMARY OF POSITION:
The CRA will help plan and conduct site initiation (including onsite training and setup), study source data review and verification. The CRA will also verify that onsite testing has been correctly conducted and recorded, that biological specimens have been appropriately handled, stored, labelled, and shipped, and that investigational product accountability has been properly documented.
This position requires up to approximately 50% travel. When not traveling this position assists with in-house clinical team activities, such as assembly of clinical study supplies and materials, instrument configuration, inventory, shipment and tracking of study materials, maintenance of files and records in the Trial Master File (TMF), data entry and data management activities.
- Ensure clinical study data are accurate via source verification, query initiation and resolution
- Ensure sites are following the clinical study protocol, GCP, and all applicable regulations
- Conduct study site selection, qualification, training, start up, and close out
- Support IRB submissions
- Act as a primary contact between the site and the study sponsor
- Ensure proper inventory, storage, shipment, and tracking of study materials
- Ensure proper handling, storage, tracking, and shipment of clinical specimens
- Assist with data entry as necessary
- Maintain Trial Master Files for all assigned clinical studies
- Assemble and ship IUO kits and supplies for clinical studies
EDUCATION, SKILLS & EXPERIENCE
A BS/BA is required (biology, chemistry, or related scientific or engineering field preferred). A minimum of 2 years’ direct experience in clinical study monitoring is required. Experience in IVD is preferred, with a proven track record of progressive clinical study responsibility.
NOTE: Candidates that are offered a position are required to pass pre-employment drug and background screening. Qualified candidates with criminal histories, are considered in a manner that is consistent with local, state and federal laws.