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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 environment. Exposure to Biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. Exposure to electrical office equipment. Frequently sits for 4-6 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Occasionally walks. Occasionally bends and twists neck and waist. Light to moderate lifting and carrying objects with a maximum lift of 25lb. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Frequently performs tasks by following a set of written or oral instructions/procedures. Travel in the United States, occasional international travel.
Pay Scale
The estimated pay scale for this Clinical Affairs Specialist role based in San Diego, CA, is $103,078 to $128,848 per year. Additionally, the position is eligible to participate in up to 8% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!
Third Party Agency and Recruiter Notice:
Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.
Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg
Learn more about Grifols