Clinical Trials Associate

Employment Type

: Full-Time

Industry

: Miscellaneous



Quidel Corporation is a leading manufacturer of diagnostic healthcare solutions serving to enhance the health and well being of people around the globe with well known and respected products that provide healthcare professionals with accurate and cost-effective diagnostic information at the point of care (POC). Our core competencies and capabilities focus on immunoassay and molecular testing in the areas of: infectious disease, cardiology, women's health, and virology.Assist in all clinical team activities for start-up, oversight, and study closure to include coordinating the preparation and assembly of clinical trial supplies, equipment and materials, and distribution to clinical sites with minimal/moderate supervision. Maintain related tracking information of all clinical materials, shipments, and inventory. Ensure proper receipt, storage, tracking, shipping, and retrieval of clinical samples. 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. 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.ESSENTIAL FUNCTIONS:* Responsible for maintaining Trial Master Files for all clinical studies* Work closely with the clinical team to provide in-house support for all phases of clinical studies* Assemble and ship investigational material kits and supplies for clinical studies* Under the direction of the Trial Manager, ensure that sites are properly supplied with necessary materials throughout the clinical study* As necessary, assist with data entry and the auditing of clinical study data* Responsible for the receipt, storage, tracking, shipping, and retrieval of clinical samples* Ensure that samples shipped to the clinical team are picked up in a timely manner* Ensure that the samples shipped to the clinical team are properly handled and stored, and that any necessary environmental conditions (e.g. cryopreservation) are maintained* Track and maintain proper documentation for sample inventory, usage, freeze-thaws, and estimated volumes* Generate timely reports on sample inventory

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