Clinical Research Associate II - 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. The CRA role is one which can be distinguished across three different levels in industry. These levels are CRA I, CRA II and CRA III (also referred to as a Senior CRA). The level of responsibility and role complexity escalates as the CRA moves from a CRA I to III. The essential duties and responsibilities of each of the CRA roles is described below:

Essential Duties and Responsibilities

CRA I:

The CRA I reports to the Study Manager or the CRA III. Duties and responsibilities include the following. Other duties may be assigned depending on the needs of the organization:

• Review protocols, investigator brochures
• Set up and maintenance of study files, including administration of Florence eTMF where used in Presidio clinical studies and supporting any use of CTMS in Presidio clinical studies
• Drafting and review of participant information sheets and informed consents
• Review of CRFs
• Assist in investigator selection processes, including:

• Searching for sites
• Preparing NDAs
• Preparing and sending feasibility questionnaires
• Performing pre-study visits (with CRA III or SM as required)

• Setting up the clinical study sites, including:

• Ensuring each center has the 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)

• Monitoring the clinical study throughout its duration, which will involve:

• Visiting the study sites or performing remotely (or both)
• Verifying that data entered on to the CRFs is consistent with participant clinical notes, known as source data verification (SDV)
• 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
• Overseeing device accountability

• General study management including:

• Site communication
• Internal communication
• TMF filing
• Assist in the distribution and management of inventory of clinical trial supplies
• Preparation of annual trial progress reports for IRBs/ECs and Regulatory Authorities under supervision of a CRA III or SM
• Assist in reporting Serious Adverse Event to IRBs/ECs and Regulatory Authorities under supervision of a CRA III or SM
• Preparing submissions to Institutional Review Boards (IRBs) / Ethics Committees (ECs) and Regulatory Authorities under the supervision of a CRA II, III or SM, and assisting in administrative tasks for submissions
• Keeping study trackers/study progress overviews up to date

• Assisting in performing User Acceptance Testing of EDC with Data Management
• Working together with Data Management to obtain a clean database and to solve queries in preparation for milestone activities such as database locl
• Assisting in preparing study related training materials
• Participating in project meetings and investigator meetings and writing minutes
• Preparations for audits and inspections
• Completion of TMF and ISF routine audits
• Assisting in organizing investigator meetings

CRA II:

The CRA II reports to the Study Manager or the CRA III and is required to be able to perform all CRA I activities, with the following additional duties and responsibilities. Other duties may be assigned depending on the needs of the organization:

• Be able to independently perform submissions, or preparations for site submissions, to Institutional Review Boards (IRBs) / Ethics Committees (ECs) and Regulatory Authorities and follow up till approval is obtained
• Oversee the distribution and management of inventory of clinical trial supplies ensuring that device accountability requirements are adhered to
• Independently prepare clinical trial agreements and participate in budget negotiations between site and Presidio
• Independently prepare annual trial progress reports for IRBs/ECs and Regulatory Authorities
• Assist sites with reporting Serious Adverse Event to IRBs/ECs and Regulatory Authorities and investigators
• Independently perform User Acceptance Testing of EDC
• Independently manage electronic tools such as CTMS or eTMF systems
• Independently prepare study related training materials
• Provide input for updates of SOPs and drafting of new quality documentation
•  Assist in giving on-the-job training and instructions to CRA I level team members and support any co-monitoring requirements as requested by the CRA III

CRA III (Senior CRA):

The CRA III 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:

• 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

CRA I:

• B.S. or higher degree in Engineering or associated fields, or equivalent industry experience
• Ability to create, implement and evaluate operational and administrative processes
• ISO14155 and ICH GCP knowledge
• Knowledge of US FDA CFR and Australian TGA regulations and guidelines applicable to conducting clinical trials (i.e. GCP certification or similar)
• 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
• Ability to understand basic and complex medical details

CRA II:

 All of the above, plus:

• 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
• Be a "doer," with a "roll-up-your-sleeves" attitude who is attracted to the entrepreneurial environment, which requires hard work and strong commitment.
• At least 2 years of Clinical Research experience in medical device clinical trials

CRA III (Senior CRA):

All of the above, plus:

• 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
• Extensive knowledge of US FDA CFR and Australian TGA regulations and guidelines applicable to conducting clinical trials (i.e. GCP certification or similar).
• 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.

Physical Demands

· Varied sitting, standing and walking

· Ability to lift and carry 50lbs. or less

Position Details

 · Position is in South San Francisco or Melbourne depending on recruitment plan. Travel to remote sites may be necessary.

Application Information

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

Brad Sheehan

Director Clinical and Regulatory

bsheehan@presidiomedical.com

Please reference: Clinical Research Associate [I, II or III – strike out NA roles]