Clinical Research Associate II - East Coast - San Mateo

Organization Overview

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

• 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

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