Clinical Research Associate II

BrioHealth Solutions; United States; On-site; USD 70,000 - 90,000; Full time

Job summary

BrioHealth Solutions is looking for a Clinical Research Associate II to join its Clinical team and support clinical trials for an innovative heart failure therapy. The ideal candidate has at least 3 years of clinical research experience, strong understanding of regulations, and excellent organizational and communication skills.

This role offers a hands-on opportunity to contribute to the advancement of patient care through clinical studies. Travel may be required beyond 30% depending on study needs.

Qualifications

• Minimum of 3 years of clinical research experience supporting medical device clinical trials.
• Strong working knowledge of ICH-GCP and U.S. FDA regulations.
• Current GCP certification preferred.

Responsibilities

• Conduct Site Qualification Visits and Site Initiation Visits.
• Manage site-level regulatory submissions ensuring accuracy.
• Perform User Acceptance Testing for clinical systems.

Skills

Clinical research experience

Understanding of ICH-GCP

Organizational skills

Communication skills

Ability to manage multiple priorities

Education

Bachelor’s degree in a scientific or healthcare-related discipline

Tools

EDC

CTMS

eTMF

Job description

Overview

We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes. We have developed an advanced and unique heart failure therapy technology in the BrioVAD® Left Ventricular Assist System (LVAS). We are introducing the BrioVAD LVAS to Heart Failure clinicians for use with the large number of indicated and untreated patients who could benefit from chronic mechanical circulatory support. The initiation of our INNOVATE™ Trial in the US is only the beginning. We are building a team to develop advanced technology intended to further improve patient outcomes, increase therapy acceptance, and enabling chronic MCS therapy to be accessible to more patients across the globe.

The Role

BrioHealth Solutions is expanding its Clinical team and seeking a Clinical Research Associate II to support the execution of clinical trials for our novel LVAS device. This role is responsible for monitoring trial conduct, ensuring data integrity, and supporting compliance across sites throughout the clinical study lifecycle.

This is a hands-on opportunity to contribute directly to a first-in-class therapy advancing care for patients with advanced heart failure. If you are a detail-oriented CRA who thrives in fast-moving, early-stage clinical environments, we encourage you to apply.

What You\'ll Do

• 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, and 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.

What You Bring

• 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; current GCP certification preferred.
• 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.
• Willingness and ability to travel greater than 30%, as required by study and site needs.