Senior Clinical Studies Associate

About the role

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.

Responsibilities

• Identify potential external sites for the evaluation of new DiaSorin 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 DiaSorin personnel for final signature.
• Periodically review the sites for contract compliance during the clinical trial process.
• Carefully 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 DiaSorin and external collaborators for the exchange of information regarding contracts, IRB/HIPPA information, clinical trial instructions, technical data, and reports.
• Maintain oversight of the performance of clinical trial sites by reviewing procedures, personnel, and data generated at the sites including period visits to all clinical trial sites.
• Work with the clinical trial sites to ensure clinical trial data is published in peer-reviewed journals or other appropriate platforms.
• Aid 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.

Qualifications

• Bachelor's Degree (RN a plus)
• 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.
• Experience and competency in interacting and communicating with external collaborators and clients.
• ACRP-CP Certification Preferred
• Knowledgeable of and technically competent with all of DiaSorin’s products in development and slated for clinical trials.
• Training and experience in laboratory platforms similar to those that will be used in future clinical trials.
• A background in Medical Technology is not required but would be a definite advantage.
• The position requires the maintenance of documentation to meet specific quality standards.
• Excellent communication, project management, time management, and people skills.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to work with mathematical concepts such as probability and statistical inference.
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.