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Clinical Research Associate
Posted on 11/29/2022
INACTIVE
Locations
Athens, OH, USA
Experience Level
Entry
Junior
Mid
Senior
Expert
Desired Skills
Google Cloud Platform
Management
Communications
Requirements
  • BS / BA in scientific discipline or equivalent combination of education and work experience required
  • A minimum of 2 years progressive biological laboratory employment and/or clinical research monitoring experience required in the IVD (in vitro diagnostic), medical device or bio/pharma industry is highly desirable
  • Additional experience in study design, data management and statistical analysis in the IVD, medical device, or bio/pharma industry highly desirable
  • Certification or prior experience in clinical trials design, clinical monitoring, and/or management highly desirable
  • Experience with SOP development is preferred
  • A strong background in laboratory science, with monoclonal antibodies application, cell based system application, and molecular application experience preferred
  • Understanding of relevant ISO Regulations and GCP is required
  • A strong working knowledge or willingness to learn of regulatory requirements governing clinical laboratories required
  • Knowledge of medical terminology and good clinical practice required
  • Orientation to detail with a high level of organizational skills, and ability to work quickly and accurately in a fast-paced environment, required
  • Detail-oriented with a high level of organizational skills; good written and verbal communication skills; excellent interpersonal skills, always maintains professionalism, with ability to resolve conflict
  • Good written and verbal communication skills, required
  • Excellent interpersonal skills, ability to handle inter/intradepartmental issues in a cooperative and diplomatic manner and the ability to assert an appropriate level of authority when interacting with team members in a wide variety of experience, talent, and know-how, required
  • Advanced computer skills and statistical analysis experience, preferred
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
Quidel

501-1,000 employees

Diagnostic healthcare manufacturer
Company Overview
Quidel’s mission is to provide patients with immediate and frequent access to highly accurate, affordable testing for the good of families, communities, and the world. The company is delivering a continuum of diagnostic solutions from advanced lateral-flow, direct fluorescent antibodies, and molecular diagnostic tests that improve the quality of healthcare.
Benefits
  • Medical, dental, & vision
  • 401k
  • Income replacement
  • Employee stock purchase plan
  • Vacation & Holidays
  • Great work environment
Company Core Values
  • Customer Driven
  • Focused on Execution
  • New Product Oriented
  • Determined
  • Optimistic
  • Team Players