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 Principal CRA is to oversee and ensure 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 Principal 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 requirements.  The essential duties and responsibilities of Principal CRA role are described below:

 

Essential Duties and Responsibilities

 

  • Review of protocols and items that are relevant for monitoring:
    • Safety reporting requirements
    • Monitoring activities
    • Source worksheet / data collection tools
    • Data management
    • Descriptions of procedures during subject visits
    • Visit windows, etc.
  • Leads the development of monitoring plans
  • Leads the development of participant information and informed consents against protocol requirements
  • Monitors and tracks study implementation and progress
  • Oversees maintenance of and contributes to study files, including administration of Florence eTMF where used in Presidio clinical studies
  • Assists in organizing communication flow across the study team
  • Prepares study progress reports as required (internal and external) and provides study updates in company meetings (Cross Functional, All Hands, etc)
  • Identifies problems that impact or will potentially impact study goals
  • Implements strategies to resolve study related issues in consultation with team members
  • Supports investigator selection processes, including:
    • Searching for sites
    • Preparing NDAs
    • Preparing and sending feasibility questionnaires
    • Performing pre-study visits (with CRAs as required)
  • Sets up the clinical study sites, including:
    • Ensuring each center has sufficient clinical trial materials
    • Participating in training of site staff on the clinical study, GCP, study standard operating procedures and applicable regulations (assisting in the performance of initiation visits)
  • Oversees monitoring the clinical study throughout its duration, which will involve:
    • May from time to time need to participate in visiting the study sites in person or performing monitoring remotely (or both)
    • May from time to time need to participate in closing out of study centers on completion of the trial or for other reasons (close out visits)
    • Writing accurate and timely visit reports in accordance with the monitoring plan
  • Contributes to overseeing device accountability for clinical studies:
    • Assists in the distribution and management of inventory of clinical trial supplies
    • Assists in accountability reconciliation
    • Contributes to device deficiency documentation processes
  • Organizes and participates in investigator and team meetings and site meetings:
    • Principal CRA must be able to give informative presentations during meetings and take a lead role in project team meetings with CRAs and/or sites members
  • Oversees documentation preparation and reconciliation for site payments
  • Contributes to:
    • Preparing submissions, including annual trial progress reports, to Institutional Review Boards (IRBs) / Ethics Committees (ECs) and Regulatory Authorities
    • Reporting Serious Adverse Events to IRBs/ECs and Regulatory Authorities as required
    • Keeping study trackers/study progress overviews up to date
  • Data Management:
    • Assists in drafting / reviewing Case Report Forms with Data Management
    • Assists in performing User Acceptance Testing of EDC with Data Management
    • Works with Data Management to obtain a clean database and to resolve queries in preparation for milestone activities, such as database lock
  • Quality:
    • Provides input to improve and ensure clinical study quality
    • Provides critical review of departmental SOPs and provides feedback
    • Prepares for audits and inspections
    • Completes TMF and ISF routine audits

 

    • Other responsibilities as needed.

Qualification Requirements

 

Experience

  • B.S. or higher degree in Science or Nursing, or equivalent industry experience
  • Knowledge of ISO 14155, ICH GCP, US FDA CFRs and Australian TGA regulations and guidelines applicable to conducting clinical trials
  • Flexibility to travel extensively, internationally and within the US
  • Be responsive, "quick-on-their-feet", when experiencing changes in Company objectives, understanding that we operate in a start-up environment
  • Proficient in the use of computer and software systems
  • Able to understand basic and complex medical details
  • Be a "doer," with a "roll-up-your-sleeves" attitude who is attracted to the entrepreneurial environment, which requires hard work and strong commitment
  • Experience managing small or large clinical trials from protocol development to final report
  • At least 5+ years of Clinical Research experience with ideally > 2 years in medical device clinical trials
  • Ideally experienced in the Active Implantable Medical Device Industry, along with executing studies under the Investigational Device Exemption program
  • Demonstrated knowledge of protocol and device development processes, clinical study design, study planning and management, and data monitoring

 

Physical Demands

 

  • Varied sitting, standing and walking
  • Ability to lift and carry 50lbs. or less

 

Position Details

 

  • Position is located in San Mateo, CA
  • Travel to remote sites may be necessary.
  • This role is not eligible for sponsorship.

 

Application Information

 

Please send an up-to-date CV or resume along with a brief introduction to:

            Brad Sheehan

            Senior Director Clinical and Regulatory

            bsheehan@presidiomedical.com

            Please reference: Principal CRA