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 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.
The 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.
The Individual
Required Skills:
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.
Preferred Skills:
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.
The Key Working Relationships
Internal partners: Works collaboratively across different business units including R&D, shipping, manufacturing, clinical operations, regulatory and scientific affairs.
External partners: Clinical Site Coordinators, Principle Investigators and Clinical Sample Procurement Companies.
The Work Environment
The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include handling of viral and bacterial hazards, potentially hazardous chemicals, as well as infectious or potentially infectious bodily fluids, tissues, and samples. Up to 75% of the time at desk, standing or sitting extended periods of time. Flexible work hours to meet project deadlines.
Ortho may amend, terminate, or enhance the benefits provided, as it deems appropriate.
Equal Employment Opportunity
QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com.
#LI-HF1