Senior Clinical Studies Associate

Senior Clinical Studies Associate

Job Scope

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.

This position is onsite in our Stillwater, MN location.

Key Duties and Responsibilities

• In collaboration with other Dia Sorin staff, identify potential external sites for the evaluation of new Dia Sorin IVDs and performance of clinical trials.
• Perform detailed investigations, including site visits, to evaluate the technical capability of potential external collaborators.
• Participate in the development of clinical trial protocols, which will include evaluation of the individual site’s technical and logistical capabilities to perform the protocols.
• Initiate contract negotiations with external collaborators and present to the appropriate Dia Sorin personnel for final signature. Periodically review the sites for contract compliance during the clinical trial process.
• Coordinate and manage the clinical specimen acquisition process.
• Coordinate any training required at external collaboration sites, which may include providing on‑site training.
• Act as the primary contact person between Dia Sorin and external collaborators for the exchange of information regarding contracts, IRB/HIPAA information, clinical trial instructions, technical data, and reports.
• Monitor the performance of clinical trial sites by reviewing procedures, personnel and data generated at the sites including period visits to all clinical trial sites.
• Serve as the coordinator of cross‑functional departments and teams such as R&D, manufacturing, Regulatory Affairs, Marketing, and Technical Services to bring products through the regulatory process and launch to the field.
• Work with the clinical trial sites to ensure clinical trial data is published in peer‑reviewed journals or other appropriate platforms.
• Assist in developing the economical models for the proper positioning of new products for the market.
• Identify speakers, venues, and other resources for the pre‑market positioning of new products.
• Institute and maintain a cost accounting and management system for external test and clinical trial sites.
• Research technical questions through review of periodicals, interaction with in‑house personnel, the Internet, and any other resource.
• Responsible for performing assigned tasks in accordance with applicable safety regulations and instructions, as well as correcting unsafe work habits and practices and/or bringing to the attention of the Safety Team or a supervisor any practice or condition that may be detrimental to the safety and health of the employees. You also have a responsibility to cooperate in all safety or health‑related programs and assist in solving safety and health problems.
  
  Violations of safety directives and procedures will be handled in accordance with the established Company disciplinary process.
• Perform other duties as assigned.

Education, Experience and Qualifications

• Bachelor's Degree (RN a plus) Required
• Advanced Degree, e.g., Master or Doctorate Preferred
• 5+ Years experience in the field of IVD and 5 or more years’ experience in laboratory medicine. Required
• The person should have experience and be competent in…