Senior Clinical Research Associate (CRA III) - East Coast

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. 

Essential Duties and Responsibilities

The CRA III reports to the Study Manager and is required to be able to perform all levels of activities typically associated with lower level CRA I/II roles, in addition to the following more complex duties and responsibilities. Other duties may be assigned depending on the needs of the organization:

• Responsible for completeness of study files
• Assisting the SM in the development of project plans, monitoring plans and communicating the plan and timelines to CRAs
• Review of protocols and investigator brochures against ISO14155
• 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.
• Leading the development of source worksheets and participant information and informed consents against protocol requirements
• Assists in drafting / reviewing Case Report Forms with Data Management
• Monitoring and tracks study implementation and progress
• Preparation of study progress reports as required (internal and external)
• Assisting the SM in organizing communication flow across the study team
• Acts as liaison between CRAs and other functional departments (Presidio cross functional representative)
• Provides study updates in company meetings (Cross Functional, All Hands, etc)
• Identifies problems that impact or potentially impact study goals
• Implements strategies to resolve study related issues in consultation with SM
• Leadership of CRA Team:
  • Leads the development of monitoring plans
  • Mentors the study monitoring team
  • Coordinates monitoring activities
  • Conducts co-monitoring / training visits (acting as the Lead CRA)
  • Identifies CRA performance issues and communicates issues to SM
  • Assists the SM in reviewing visit reports of other CRAs (depending on the level of experience)
  • Supports all on-boarding efforts for CRA team members
• Organizing and participating in investigator and team meetings and site meetings:
  • CRA IIIs must be able to give presentations during meetings and take a lead role in project team meetings with CRAs and/or sites members
• Prepares and reviews documentation for site payments
• Quality:
  • Provide input to improve and ensuring study quality
  • Prepare for audits and inspections
  • Provide critical review of departmental SOPs and provide feedback
• Project Management:
  • CRA III roles may be expected to project manage small studies (1-3 sites) independently

The CRA III role has a greater emphasis on study coordination, however, this role may also be responsible for directly monitoring sites within a clinical trial. The CRA III 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

• B.S. or higher degree in Engineering or associated fields, or equivalent industry experience
• 5 years of Clinical Research experience with ideally > 2 years in medical device clinical trials
• Ability to create, implement and evaluate operational and administrative processes
• ISO14155 and ICH GCP knowledge
• Flexibility to travel extensively, internationally and within the US
• Knowledge of principles of clinical research study design and approaches to statistical analysis.
• Strong knowledge of Good Clinical Practice (GCP) and US and international regulations for clinical trials
• Extensive knowledge of US FDA CFR and Australian TGA regulations and guidelines applicable to conducting clinical trials (i.e. GCP certification or similar).
• Experience managing small or large clinical trials from protocol development to final report
• Demonstrated knowledge of protocol and device development processes, clinical study design, study planning and management, and data monitoring.
• Demonstrated ability to lead CRA teams.
• Demonstrated ability to take ownership of projects to successful conclusion.
• Demonstrated experience in project management and budgeting experience.
• Proficient in the use of computer and software systems

Physical Demands

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