Clinical Trials Associate

As we continue to thrive together QuidelOrtho is seeking a Clinical Trials Associate to support in all clinical team activities for start-up, oversight, and study closure to include coordinating the preparation and assembly of clinical trial supplies and materials for distribution to clinical sites with minimal/moderate supervision. Maintain related tracking information of all clinical materials, shipments, and inventory. Assist the Data Management team in tracking and management of Case Report Forms (CRFs) and Laboratory submission Forms (LSFs). Assist in maintaining files and tracking of all written and electronic documentation for all study records and site interactions in the Trial Master File (TMF). Communicate with sites regarding query resolution to ensure compliance with specified protocols and accuracy of submitted data. Participate in data entry, data auditing, clinical site queries and overall clinical data flow from multiple clinical sites in a timely and professional manner. Coordinate in-house specimen procurement studies. Willingness and ability to learn, understand and apply regulatory guidelines and Good Clinical Practices (GCP’s) applicable to IVD and Medical Devices for conducting clinical field trials, CLIA Waiver and 510(k) submission studies. Be familiar with GCP, FDA regulations and relevant Standard Operating Procedures for clinical research. Develop skill and knowledge with regulatory procedures and become familiar with Quidel product development procedures. Interact with study coordinators and in-house study participants.