Clinical Research Associate II

BrioHealth Solutions is a med-tech company developing patient-centric heart failure therapies, including the BrioVAD Left Ventricular Assist System. The Clinical Research Associate II will support clinical trial execution by monitoring sites, ensuring data integrity and protocol compliance, managing regulatory submissions and trial supplies, and maintaining clinical systems throughout the study lifecycle.

Responsibilities

Perform all CRA I responsibilities, with increased independence, complexity, and accountability as outlined below

Conduct Site Qualification Visits (SQVs), Site Initiation Visits (SIVs), Interim Monitoring Visits, and Close-Out Visits in accordance with the Monitoring Plan and ICH-GCP

Build and maintain strong, professional relationships with investigative sites through: -On-site and remote monitoring activities. -Source data verification (SDV) and review of CRFs against source documentation. -Oversight of protocol compliance and data quality. -Timely and accurate preparation of monitoring visit reports. -Management and reconciliation of investigational device accountability

Independently manage site-level regulatory submissions, including IRB/EC and applicable regulatory authority submissions, ensuring completeness, accuracy, and timely follow-up through approval

Oversee the distribution, tracking, and reconciliation of clinical trial supplies, ensuring compliance with investigational device accountability and study requirements

Independently prepare and submit annual progress reports and other required continuing review documentation to IRBs/ECs and Regulatory Authorities

Support investigative sites with the identification, documentation, and reporting of Serious Adverse Events (SAEs) in accordance with protocol, SOPs, and regulatory requirements

Independently perform User Acceptance Testing (UAT) for Electronic Data Capture (EDC) and other clinical systems, documenting findings and supporting resolution

Utilize and maintain clinical trial systems, including CTMS and eTMF, ensuring accuracy, completeness, and inspection readiness

Independently develop and maintain study-related training materials and support site training as needed

Contribute to the review, revision, and development of SOPs and other quality documents to support continuous improvement of clinical operations

Provide on-the-job training, mentorship, and guidance to CRA I team members; support co-monitoring activities and escalation as requested by CRA III or Clinical leadership

Preferred

current GCP certification preferred

Google Cloud Platform Certification

Company

Develops ventricular assist systems for advanced heart failure treatment

Burlington, Massachusetts, USA

https://briohealthsolutions.com/

Founded in 2008

51-200 employees

Qualifications

Bachelor's degree or higher in a scientific or healthcare-related discipline, or equivalent relevant industry experience

Minimum of 3 years of clinical research experience, with demonstrated experience supporting medical device clinical trials

Strong working knowledge of ICH-GCP, U.S. FDA regulations (21 CFR), and applicable clinical trial requirements

Demonstrated ability to independently manage operational and administrative clinical trial activities, including process development, execution, and continuous improvement

Proficiency with clinical trial systems and tools, including EDC, CTMS, and eTMF platforms

Solid understanding of clinical trial design principles, data collection methodologies, and basic statistical concepts relevant to clinical research

Ability to interpret and apply medical and scientific information, including both foundational and complex clinical concepts

Strong organizational, documentation, and communication skills, with the ability to manage multiple priorities in a regulated environment

Current GCP certification preferred

Minimum of 3 years of clinical research experience, with demonstrated experience supporting medical device clinical trials.

Required skills

Medical Device Clinical Trials, ICH-GCP, U.S. FDA Regulations (21 CFR), GCP Certification, Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), Clinical Trial Design, Clinical Data Collection Methodologies, Statistics, Clinical Concepts

Preferred skills

current GCP certification preferred, Burlington, Massachusetts, USA, https://briohealthsolutions.com/, H1B Sponsorship, Data Powered by, Distribution of Different Job Fields Receiving Sponsorship, 50, Represents job field similar to this job, Engineering and Development, Management and Executive, Trends of Total Sponsorships, *2026, (1), 2025, Growth Stage, Leadership Team, Petrus Jansen, Vice President Medical Affairs, Recent News, PR Newswire, 2026-04-27, Company data provided by, AI Tools, Customize Your Resume, Maximize your interview chances, Build Cover Letter, Make your application stand out, Analyze How Well You Fit, Understand your strength & weakness

Experience

3+ years