Clinical Research Associate

QuidelOrtho•Athens, OH

22h•Onsite

About The Position

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. As we continue to grow as QuidelOrtho, we are seeking a Clinical Research Associate to help to write clinical protocols for beta-site and formal clinical studies; and identifies, sets up and monitors clinical trials for new IVD (in vitro diagnostics and medical devices) investigational products, including instruments and test devices. This position onsite and is located in Athens, OH.

Requirements

BS / BA in scientific discipline or equivalent combination of education and work experience.
A minimum of 2 years progressive biological laboratory employment and/or clinical research monitoring experience required in the IVD (in vitro diagnostic).
Understanding of relevant ISO Regulations and GCP.
This position is not currently eligible for visa sponsorship.

Nice To Haves

Additional experience in study design, data management and statistical analysis in the IVD.
Certification or prior experience in clinical trials design, clinical monitoring, and/or management.
Experience in the medical device or bio/pharma industry.
Experience with SOP development.
A strong background in laboratory science, with monoclonal antibodies application, cell based system application, and molecular application experience.

Responsibilities

Ensures clinical study data are accurate via source verification, query initiation and resolution.
Ensures sites are following the clinical study protocol, GCP, and all applicable regulations.
Conducts study site selection, qualification, training, start up, and close out.
Supports Institutional Review Board/Ethics Committee submissions.
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.
Ensures compliance U.S. QSR and ISO9000 regulations, Good Clinical Practice, FDA regulations and relevant Standard Operating Procedures for clinical research.
Acts as a primary contact between the site and the study sponsor.
Ensures proper inventory, storage, shipment, and tracking of study materials.
Ensures proper handling, storage, tracking, and shipment of clinical specimens.
Assists with data entry as necessary.
Maintains Trial Master Files for all assigned clinical studies.
Assists in developing departmental Standard Operating Procedures.
Assembles and ship IUO kits and supplies for clinical studies.
Perform other work-related duties as assigned.