Clinical Research Associate II - East Coast

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.

Essential Duties and Responsibilities

Duties and responsibilities include the following. 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

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

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

Qualification Requirements

Experience

B.S. or higher degree in Engineering or associated fields, or equivalent industry experience

At least 2+ years of Clinical Research experience in medical device clinical trials

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

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

Proficient in the use of computer and software systems

Ability to understand basic and complex medical details

Physical Demands

Varied sitting, standing and walking

Ability to lift and carry 50lbs. or less

Clinical Research Associate II - East Coast

Presidio Medical, Inc.

San Mateo, CA

Full Time

USD 85,000.00 - 115,000.00 per year

Published on 05/30/2025