Presidio Medical, Inc.
Location
South San Francisco, CA | United States
Job description
Organization Overview
Presidio Medical is developing neuromodulation technology with the potential to transform the field of neuromodulation with an initial focus on treating chronic pain. Presidio is led by a highly experienced team with a successful track record of medical device commercialization with deep expertise in pain management and neurostimulation. The expertise has allowed Presidio to develop a comprehensive design and development plan to move quickly through prototype builds, animal studies, and clinical use. Enabled by this prior activity, initial clinical work has demonstrated therapeutic efficacy with exceptional outcomes. The team is now working on the next generation system for further clinical work and to develop Presidio’s commercial system.
Job Summary
The main responsibility of a CRA is to verify that the rights and well-being of human subjects are protected and that the reported trial data are accurate, complete, and verifiable from source documents. Most importantly, the CRA makes sure that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with ISO14155, and with applicable regulatory requirement. The essential duties and responsibilities of each of the Senior CRA role is described below:
Essential Duties and Responsibilities
The Senior CRA reports to the Study Manager and is required to be able to perform all CRA I and II activities, with the following additional duties and responsibilities. Other duties may be assigned depending on the needs of the organization:
The Senior CRA role has a greater emphasis on study coordination, however, this role may also be responsible for directly monitoring sites within a clinical trial. The Senior CRA role is required to have expertise in planning, decision making, escalating, and defining priorities and the implementation of tasks autonomously. A deep understanding of clinical study regulatory requirements and ensuring compliance, as well as people leadership and well developed interpersonal skills, is key to this position.
Qualification Requirements
Experience
Senior CRA:
All of the above, plus:
Physical Demands
Position Details
Application Information
Please send an up-to-date CV or resume along with a brief introduction to:
Brad Sheehan
Director Clinical and Regulatory
Job tags
Salary