Job: Sr. Clinical Research Associate (Sr. CRA) US
Ablative Solutions, Inc.
More than 1 billion people have hypertension (high blood pressure). More than half the people treated for hypertension and not able to do not achieve target (control) blood pressure of 130mmHG systolic over 80mmHg diastolic.
Ablative Solutions, Inc. (ASI) has developed propriety technology to treat uncontrolled hypertension
- The Peregrine System™ Kit includes the Peregrine System™ Infusion Catheter (Peregrine Catheter) and Ablative Solutions Inc.’s Dehydrated Alcohol (ETOH).
- The minimally invasive procedure is performed under mild/conscious sedation.
- The Peregrine Catheter is advanced through a small incision in the groin and guided up to the renal arteries using angiography (X-ray with contrast). The system will deliver a small dose of dehydrated alcohol to the region just outside the artery (perivascular space), where the nerves are located, to interrupt the over-signaling of the sympathetic nervous system, that contributes to hypertension; this form of therapy is called alcohol-mediated renal denervation.
The company raised $77 million in capital in January of 2019 to develop the clinical program to obtain the CE Mark and FDA approval for the Peregrine System Kit. The company is currently conducting clinical studies in Europe and the United States to collect data in support of regulatory submissions intended to gain the above approvals and bring this therapy to market.
Senior Clinical Research Associate (Sr. CRA)
The Sr. CRA is a highly motivated individual who embraces opportunity and is interested in broadening his/her skills in managing and executing clinical studies. As a pivotal member of a small clinical team, this individual will be responsible in managing all aspects of clinical studies to ensure successful execution.
The Sr. CRA will be responsible for managing clinical studies to ensure studies are completed in compliance with SOPs, appropriate regulations and Good Clinical Practice (GCP) guidelines by monitoring of clinical sites per execution of the clinical monitoring plan and ensure study files (Trial Master Files) are collected and filed appropriately. The Sr. CRA will report safety issues, patient care issues, and study design and/or study conduct issues and assist data management with site data entry timelines, data query resolution, report generation and database freeze lock. Additional responsibilities may include vendor management and oversight as well preparation of safety and final study reports.
The Sr. CRA position requires strong organizational and communication skills are required as well as extensive knowledge of conducting clinical trials, in particular those performed in US and outside of US. Individual must be detail-oriented. A Bachelor’s degree, preferably in a medical-related field, with minimum of 2 years as well as proficiency with computer software such as MS Outlook, Word, PowerPoint, Excel, is required.
Interested candidates should submit their resume and cover letter to: email@example.com