Clinical Affairs Specialist

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions in San Diego, CA is seeking a Clinical Affairs Specialist. The Clinical Affairs Specialist will execute clinical studies in accordance to IVD clinical guidelines, applicable regulatory requirements, company SOPs, and study protocols. He will contribute to the preparation and management of the execution of the different stage of clinical trials for new assays for all IVD product lines, including Immunohematology, Immunoassay and NAT. In addition, the Clinical Affairs Specialist will manage the preparation and the qualification of panels needed for the execution of the clinical studies. The Clinical Specialist will travel to clinical sites to train personnels and monitor the clinical studies. This role will support local and international clinical studies.                

 

To succeed in this role, we are seeking individuals with at least a Bachelor's: Science or health-related field or equivalent education/experience and 5 years’ experience conducting development of molecular assays or clinical research or similar with previous experience in regulated environment. Equivalency is 2 years of IVD industry experience in clinical research and technical knowledge of instrumentation and platforms.

 

Primary Responsibilities

• Monitors Clinical Data, provide trends and analysis and communicates to the clinical team
• Ensures data accuracy and verifies any questionable finding with proper documentation, thorough investigation, and appropriate follow-through, completes source data verification for clinical data and creates script to facilitate the process
• Acquires clinical specimens while controlling cost toward budget, develops procedures and manages panels preparation and qualification according to procedures      
• Provides technical guidance to laboratory personnel, assists in training, and provides cross training as needed
• Assists with development of testing plan for discrepant results investigation and executes or manages the testing according to the plan
• Collaborates cross-functionally with Technical Application Specialist, Software Application Specialist and Data Management Team to help setting up clinical trial sites, participates in troubleshooting issues
• Works with the logistic department to schedule and prepare shipment of clinical reagents and panels to the testing sites according to the timeline and sites' constrains
• Travels to the sites to participate in Site Initiation Visits (SIV) and Close-out Visit (COV), assisting the lead monitor with monitoring activities and training operators on the clinical protocols
• Forecasts reagents, instrumentations and software needs for the execution of the clinical studies at the sites
• Maintains all documents related to clinical studies including completing Trial Master File
• Supports Regulatory team for BLA submission
• Participates in or support BIMO audits                                         

 

Education

Bachelor's: Science or health-related field or equivalent education/experience

 

Experience:

5 years’ experience conducting development of molecular assays or clinical research or similar with previous experience in regulated environment
Equivalency is 2 years of IVD industry experience in clinical research and technical knowledge of instrumentation and platforms

 

Equivalency:

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: if a job level typically requires an Associate's degree plus 2 years of experience, an equivalent could include 4 years of experience or a Bachelor's degree

 

Occupational Demands

Work is performed in an office and a laboratory/clinical environm