BrioHealth Solutions · 1 day ago
Clinical Research Associate II/III
United States
Full-time
Remote
Mid, Senior Level
$120K/yr - $140K/yr
3+ years expBrioHealth Solutions is expanding its Clinical team and seeking a Clinical Research Associate (CRA II/III) to support the execution of clinical trials for their novel LVAS device. This role is responsible for monitoring trial conduct, ensuring data integrity, and supporting compliance across sites throughout the clinical study lifecycle.
BiotechnologyMedicalMedical Device
Hiring Manager
Steve K.
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
Qualification
Required
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
Preferred
Current GCP certification
Company
BrioHealth Solutions
We are a global team of like-minded Med-Tech professionals focused on patient centric solutions in a collaborative environment leading to excellent outcomes.
51-200 employees
H1B Sponsorship
BrioHealth Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
$214.83MKey Investors
HSGBluesail Medical
2025-07-21Series Unknown· $100M
2022-01-25Series D· $100M
2019-06-24Corporate Round· $14.83M
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