Clinical Research Associate at HistoSonics, Inc. Plymouth, MN

Clinical Research Associate job at HistoSonics, Inc.. Plymouth, MN.

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.

Location : Remote position, ideally candidates will live in a major metro area with an international airport in the Northeast, Southeast or West Coast.

Travel Expectation : Travel (by automobile or air, day trips and overnight stays) up to 30% of the time.

Position Summary : The Clinical Research Associate will play a key role in proactively helping the conduct of pre-market and post-market global clinical studies to ensure compliance with all the regulatory requirements and company strategic initiatives. As a member of the Clinical Affairs team, this role will work with key stakeholders to execute clinical studies. This role will be responsible for study site management, including site qualification, training, activation, and monitoring.

Key Responsibilities

• Works on assigned studies to ensure that human subject protection is maintained in accordance with Good Clinical Practice (GCP), SOPs, and applicable regulations
• Conducts on-site and remote site qualification, initiation, interim, and close-out monitoring visits
• Serve as primary point of contact for site questions relating to study enrollment and conduct; collaborate with appropriate study team members as needed
• Assists with the development and execution of clinical study documents including protocols, informed consents, case report forms, and study plans
• Communicates through verbal and written communication with site investigator and the project team on the overall site performance, trends, deficiencies, and concerns
• Ensures quality and completeness of central and site master files
• Oversees site investigational product requirements and device accountability
• Supports the planning and coordination of Investigator Meetings
• Other duties as assigned

Qualifications and Skills

• 2+ years clinical research study monitoring for medical device or related experience
• BS degree in relevant area of study
• Knowledge of federal and local regulations and policies pertinent to research involving human subjects
• Knowledge of ICH, GCP and Declaration of Helsinki
• Excellent communication, interpersonal and organizational skills
• Ability to collaborate in a team environment and work independently
• Self-starter with the ability to manage projects and effectively prioritize tasks in a dynamic, start-up environment
• Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time

HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Benefits : We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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