AMVETS Jobs

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role As we continue to grow as QuidelOrtho, we are seeking a Clinical Trials Associate to support our Clinical Affairs team. This person will be responsible for assisting 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. Assist in the operation and maintenance of our Biorepository and all reference laboratory samples. Develop skill and knowledge with regulatory procedures and become familiar with Quidel product development procedures. Interact with study coordinators and in-house study participants. This position is onsite in Athens, OH. The Position Assists with data entry as necessary, and audits field clinical trial data for inclusion in regulatory submissions. Help implement and maintain clinical trial tracking databases for each clinical study. Responsible for maintaining Trial Master Files for all clinical studies. Works closely with the clinical team to provide clinical support. Assists in the conduct of readability studies to validate ease-of-use of test materials and reliability of draft procedures. Assembles and ships IUO kits and supplies for clinical studies. May helps clinical team identify clinical trial sites. Assists in the preparation for initiation of clinical studies and monitors and tracks the progress of those studies via in-house oversight. Supports obtaining IRB study approvals through direct communication with clinical sites enabling acquisition of required regulatory submission documents. Recruits subject for in-house specimen acquisition and maintains necessary supplies for specimen acquisition in support of development needs. Perform other work-related duties as assigned. The Individual Required: Requires a BS/BA in any biological science or Medical Technologist degree (or equivalent combination education and/or work experience) with a minimal of 1-2 years progressive clinical research experience.<