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 Summary :
The Principal Clinical Research Associate (Pr. CRA) develops, manages and executes high-quality global clinical studies in collaboration with the Clinical Affairs team in accordance with applicable regulatory requirements and the company's strategic imperatives. The Sr. CRA leads all activities of site management including qualification, training, activation and monitoring. The Sr. CRA will ensure site performance and study compliance.
Key Responsibilities :
- Manages clinical sites - including qualification, training, activation, interim and close-out monitoring and primary point of contact for study sites
- Assists in the development and execution of clinical study documents including Protocol, Informed Consent, Case Report Forms and Study Tools
- Prepares and conducts site visits - including site qualification, study initiation, interim monitoring, and close-out visits
- Assists in preparing interim study analyses, annual reports, and clinical study reports
- Maintains study timeline and milestones
- Determine and oversee site investigational product requirements and accountability and other supply requirements
- Effectively and professionally interacts with Primary Investigators, Research Coordinators, and other site staff to ensure efficient site management throughout the study
- Supports the planning and coordination of Investigator Meetings
- Assists the Regulatory Affairs and Quality Assurance teams in preparation for reporting and submissions
- Assists in internal and external audits
- Takes responsibility for ongoing file maintenance (study team training records, site and study files, etc.) to enable audit-readiness
- Communicates and elevates risks and potential mitigations throughout studies to Clinical Affairs team
- Represent HistoSonics and maintain strong relationships with investigators, study site personnel, and collaborator
Qualifications and Skills :
- Bachelor's degree in relevant area of study
- Minimum of 8 years' medical device CRA experience
- Knowledge of, and experience with, the FDA and the EU regulatory environments
- Excellent written and verbal communication skills; comfortable with participating in high-level technological and clinical discussions; ability to discuss complex technology in clear, discernible terms with less technically knowledgeable parties as well as presentation skills are required along with top level interpersonal and facilitation skills.
- Demonstrated ability to develop and maintain relationships, internally and externally.
- Demonstrated ability to effectively prioritize multiple tasks and deadlines and possess excellent follow through skills. Highly motivated, efficient, and enterprising with an inherent ability to drive tasks and projects to full completion.
- Demonstrated record of converting strategic plans to prioritized product, development, and/or operational objectives
- Strong analytical, critical thinking, and problem-solving skills with an attention to detail and organizational goals.
- Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time.
- Demonstrated ability to handle shifting priorities in a fast-paced environment while maintaining communication with team and manager
- Proficient in Microsoft Office, Word, and Power Point and clinical database management software
Working Conditions :
Physical abilities - must be able to lift 20lbs
Mental abilities - ability to view computer screen for 8 hours per day
Work is performed on-site in an office environment with exposure to electrical office equipment
Travel
Must be willing and able to travel (by automobile or air, day trips and overnight stays) up to 30% of the time.
Periodically drive to local site locations/meetings
Salary Range : $125,000-$140,000, plus bonus.
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. HistoSonics, Inc.
Job Tags
Full time, Temporary work, Interim role, Local area, Remote job, Shift work, Night shift,