Legal Entity: DiaSorin Molecular LLC Organizational Area: USA & Canada Country / State: USA /California Place of Work: Cypress Home/Office Based: Office based Professional Family: Clinical Affairs Reporting To: Manager, Clinical Affairs, North America
The position oversees the clinical trial process for new diagnostic products.
The process includes participating in the development of clinical trial protocols, establishing the capabilities required for the clinical trial sites to complete the protocols, identifying sites having the proper clinical trial capabilities, managing the clinical trial contract process, and managing the clinical trial sites for compliance.
Training of clinical trial sites and internal departments such as Technical Services may be required. Coordinating the logistics of sample and data transfer as well as cost accounting of the clinical trial process will be performed.
The post-clinical trial activities of this position include coordinating cross-functional teams to launch a new product or device, ensure publications and white papers are available, and assist in the pre-market positioning of the new product. The clinical trial sites may be either domestic or international, so periodic field travel can be expected. Supports applicable regulations including ISO, Local, State, and/or Federal requirements.
Requires B.S. degree with a minimum of 7 years experience in the field of IVD and 5 or more years experience in laboratory medicine.
Principal Clinical Affairs Specialist should be knowledgeable of and technically competent with all of DiaSorin Molecular’s products in development and slated for clinical trials.
The person should have training and experience in laboratory platforms similar to those that will be used in future clinical trials.
The person should have experience and be competent in interacting and communicating with external collaborators and clients.
A background in Medical Technology is not required but would be a definite advantage.
Certification as a Clinical Research Professional (CCRP) is required or will be obtained within 2 years of hire.
Additional Salary Information: As per local and Company requirements for DiaSorin Molecular LLC. A competitive compensation package including Medical, Dental, Life, STD, LTD, 401(k) or Roth 401(k) Retirement plan.
DiaSorin Molecular is dedicated to infectious disease diagnostic testing services, products, and information. We are focused on diagnostic solutions that can help improve the health of patients and populations that can help improve the world. Our company has continued to create a culture of innovation, quality, and personalized service, and we enjoy a reputation as a resource for infectious dise...ase understanding that goes beyond the test.
DiaSorin Molecular offers products used by hospitals, commercial laboratories, physicians and public health agencies to assist with the diagnosis, treatment and management of infectious diseases.