Back pain affects 50 million Americans and is the number one cause of disability in the US with a societal cost of approximately $560 billion annually. There are also over 100 million opioid prescriptions written annually, highlighting the underlying need for improved pain management solutions. While the approximately 80,000 annual Spinal Cord Stimulation (SCS) implants was a $2.5B market in 2019 and growing (8% to 10% CAGR for the prior five years), the market is ripe for disruption. Additionally, SCS devices and procedures have favorable reimbursement with existing codes in place for physicians and facilities (hospitals and ASCs).
Founded in 2017, Presidio Medical is a well-financed, clinical stage, medical device company with a transformational neuromodulation platform technology. The company is based in South San Francisco and is growing rapidly. The company’s first indication is in chronic pain. Due to the proprietary stimulation compatibilities, Presidio Medical’s technology is targeting a significant unmet pain segment which can unlock and potentially double the addressable market. In addition, Presidio has begun work outside of the lucrative SCS market and is exploring other indications with undesired nerve activity. The company is actively engaged in targeted R&D projects for patients in other disease states who will potentially benefit from the company’s proprietary technology.
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 II reports to the Study Manager and is required to be able to perform duties including:
- 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
- Assist in study start up
- 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
- Perform study Monitoring
- Assist in study management including site communications, internal communications and site and study auditing
- Duties may be assigned depending on the needs of the organization:
- 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
- Proficient in the use of computer and software systems
- Ability to understand basic and complex medical details
- 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
- At least 2+ years of Clinical Research experience in medical device clinical trials
- Varied sitting, standing and walking
- Ability to lift and carry 50lbs. or less
- Position is in South San Francisco but travel to remote sites may be necessary.