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

ODg3a2NLNHFOQm1YNGhsOHhTWXNjZWlqeXc9PQ==
  • HistoSonics, Inc.
  • Plymouth, MN

Job Description

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.

#LI-Remote

Job Tags

Full time, Temporary work, Interim role, Live in, Local area, Remote work, Night shift,

Similar Jobs

Affirmed Home Care

Pediatric LPN/RN Private Duty Nursing Job at Affirmed Home Care

 ...Weekends and Overnights Available Are you an experienced LPN or RN looking to provide high-acuity, one-on-one care in a home...  ...client with tracheostomy and ventilator Environment: In-home, private duty care Team-Oriented: Work collaboratively with a supportive... 

Volunteers of America Colorado

Part Time Delivery Driver Job at Volunteers of America Colorado

Description: WHAT MAKES VOA SPECIAL? VOAC recognizes the unique needs of the older adult who needs a wheelchair ramp to stay at home safely, and the preschooler whose family needs additional resources. VOAC supports veterans efforts to exit homelessness as well as provides...

Titan Placement Group

Advanced Practice Provider (Nurse Practitioner or Physician Assistant) Job at Titan Placement Group

 ...Advanced Practice Provider (Nurse Practitioner or Physician Assistant) Titan Placement Group invites you to explore an opportunity in Ferndale, California. This historic town is a hidden gem on California's North Coast, known for its charming main street, rich artistic... 

Zaxby's

General Manager Job at Zaxby's

Hungry For A Great Career? To our guests, Zaxbys is more than just a place to eat its a place to have fun, spend some time with friends and experience great food. Definition To manage a Zaxby's unit toward the attainment of agreed upon sales and profit goals,...

BritBox International

Associate Production Manager Job at BritBox International

 ...Job Title: Associate Production Manager Location: New York/ Hybrid WFH Company: BritBox International Reporting to: Senior Production...  ...to BritBox, the ultimate streaming destination for British TV. We bring you an unparalleled collection of thoughtfully curated...