JOB DESCRIPTION:

As the Specialist in R&D/Product Development, considered as highly experienced and knowledgeable resource within the organization in overseeing the direction, planning, execution, clinical trials/research and the data collection activities.

JOB RESPONSIBILTIES:

• Contributes to implementation of clinical protocols and facilitates completion of final reports.
• Recruits clinical investigators and negotiates study design and costs.
• Responsible for directing human clinical trials, phases III & IV for company products under development.
• Participates in adverse event reporting and safety responsibilities monitoring.
• Coordinates and provides reporting information for reports submitted to the regulatory agencies.
• Monitors adherence to protocols and determines study completion.
• Coordinates and oversees investigator initiations and group studies.
• May participate in adverse event reporting and safety responsibilities monitoring.
• May act as consultant/liaison with other corporations when working under licensing agreements.
• Travel up to 80%.

EDUCATION AND EXPERIENCE:

Required Experience:

• Associate's degree required
• 7 years of Cath Lab and/or Medical Device experience

Preferred Experience:

• Bachelor's Degree highly preferred.
• Coronary and peripheral technologies
• Clinical Trial Support experience
• Product Development
• Cath Lab Tech or Surgical Tech
• Medical Device experience
• OCT experience