Clinical Research Associate

Company: Vyaire Medical
Location: Irvine
Posted on: November 17, 2020

Job Description:

Clinical Research AssociateAbout USAt Vyaire, we help the world breathe easier. As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are a young company with a long history of revolutionary products. We devise extraordinary solutions that allow patients to lead ordinary lives. We believe the best way to create value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen. We are dedicated to anticipating what's next and get it done. We thrive on contributing and making a difference.To learn more, visit our website: www.vyaire.comWatch our video: https://www.youtube.com/watch?v=ZDrQoMbMRrI&feature=youtu.beAbout this roleVyaire teams are dedicated to connecting clinicians and patients with the highest quality respiratory healthcare solutions in the market. At Vyaire, you will find a company that puts the customer at the center of all we do. Our culture is one that rewards performance and each interaction we have with a customer furthers our mission to be the global leader in respiratory care.The Clinical Research Associate is responsible for clinical studies, site management and compliance monitoring of assigned clinical projects undertaken in support of a given product line or marketing initiative. This position must ensure that all activities will be conducted in accordance with Government Regulations (FDA, MDD and International), Good Clinical Practices (GCP) and Department Operating Procedures (DOP).Essential Functions:Can conduct full range of data collection duties, including equipment setup and operations, execution of study per procedures, collect data, verify results and transfer data back to Vyaire, etc.;Plan, implement and conclude clinical studies in support of project timelines/market release goals with minimal supervision; An advanced individual may conduct more complicated studies, as well as contributes to study proposals and protocols, applying principles of clinical study design and research methodology to assigned research projects;Prepares and documents study plans, contracts, budgets, informed consents, IRB submissions, case report forms (CRFs), and other study related materials to assure quality, consistency, compliance, organization, storage and accuracy across all assigned projects;Contribute to clinical study design, proposals, protocols, etc., understanding basic scientific content, experimental design, and analytical approaches used;Can effectively work and communicate with investigator, staff and patients in professional, sensitive and mature manner;Conduct site monitoring (qualification, initiation, monitoring and close out visits) to insure and document site is trained to follow study procedures per protocol;Likewise, can monitor safety reviews and adverse event reporting for investigational medical devices to assure adherence to Good Clinical Practices (GCP), FDA and MDD regulations;Can suggest improvements to departmental procedures relating to GCP monitoring aspects;Participate in the vendor selection process and oversee and track ongoing CRO and vendor activities as appropriate.Verify work and invoices, approve and request payments for sites, CROs and vendorsCan understand and operate Vyaire's products, data acquisition systems, following best practices for execution of study protocol and use of equipment;Insure essential study documents are properly organized and stored as quality records;Can conduct basic data analysis using spreadsheets, preparing basic calculations, statistics, graphs and tables;Writes clear, succinct and detailed clinical study and technical summary reports;Ability to travel extensively, perhaps 25-50% of the time, locally and domestically; Travel requirement is subject to change based on business needs;Must be able to lift and carry up to 20 pounds in order to: pack, ship, move, unpack, set up and execute equipment for study at clinical site, and then repack and ship back to Vyaire;Perform special projects as requestedQualifications:Experienced with Good Clinical Practice (GCP) in conduct of clinical studies;Working for both Sponsor and CROExcellent written and verbal communication skills essential;Must be capable of interacting with all levels of management, coworkers, investigators and subjects;Proficiency with Microsoft Office, computer data acquisition, data analysis, graphing and plotting results and report writingAbility to independently set and manage multiple priorities;Demonstrates advanced judgment and decision making ability in the execution / oversight of clinical studies;Ability to travel to data collection sites, local and domestic, may require up to 25-50% of time;Ability to lift and carry up to 20 pounds;Preferred QualificationsExperience with medical devices;Strong clinical background (e.g., Anesthesiology, respiratory therapy, physiology);Excellent knowledge of FDA and ISO Good Clinical Practice (GCP) Regulations, Medical Device Directive, Canadian Medical Device Regulation, and other international requirements;Preferably certified as a Clinical Research Associate;EducationPh.D. or M.S. preferable, Bachelor's degree required, preferable in Science or in a related field is required. CRA certification training is preferred. Combination of education and related experience will be considered in lieu of a Ph.D. or M.S.Atlanta, GA, Dallas, TX, Irvine, CA, Mettawa, IL, New York City, NY, Orlando, FLFull time

Keywords: Vyaire Medical, Irvine , Clinical Research Associate, Healthcare , Irvine, California