What are the responsibilities and job description for the Clinical Research Associate II position at BrioHealth Solutions?
Job Description
Job Description
About Us
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.
Job Summary
BrioHealth Solutions is expanding its clinical team and is seeking a Clinical Research Associate (CRA II) to support the launch of our innovative LVAS device. The ideal candidate will have experience in clinical trial management, specifically in overseeing and managing data collected throughout the clinical trial process. This in-house CRA role offers the chance to play a vital role in the success of our groundbreaking device. If you are passionate about making a meaningful impact on patients' lives, we encourage you to apply!
Responsibilities
Perform all CRA I activities, with additional responsibilities outlined below.
Conduct pre-study visits, including Site Qualification Visits (SQV) and Site Initiation Visits (SIV).
Build and maintain close relationships with study sites through :
On-site or remote monitoring visits.
Verifying data on CRFs against participant clinical notes.
Closing out study centers upon trial completion or other reasons (close-out visits).
Writing accurate and timely visit reports per the monitoring plan.
Overseeing device accountability.
Independently manage submissions and preparations for site submissions to Institutional Review Boards (IRBs), Ethics Committees (ECs), and Regulatory Authorities, ensuring follow-up until approval.
Oversee the distribution and management of clinical trial supplies, ensuring compliance with device accountability requirements.
Independently prepare annual trial progress reports for IRBs / ECs and Regulatory Authorities.
Assist sites with reporting Serious Adverse Events to IRBs / ECs, Regulatory Authorities, and investigators.
Independently perform User Acceptance Testing (UAT) of Electronic Data Capture (EDC) systems.
Manage electronic tools such as Clinical Trial Management Systems (CTMS) or electronic Trial Master Files (eTMF) systems.
Prepare study-related training materials independently.
Contribute to updates of Standard Operating Procedures (SOPs) and assist in drafting new quality documentation.
Provide on-the-job training and guidance to CRA I team members, and support co-monitoring as requested by CRA III.
Qualifications
B.S. or higher degree in a science-related field, or equivalent industry experience.
At least 3 years of clinical research experience, specifically in medical device clinical trials.
Proven ability to create, implement, and evaluate operational and administrative processes.
In-depth knowledge of US FDA CFR and clinical trial guidelines (e.g., GCP certification or similar).
Proficient with computer systems and software tools used in clinical research.
Strong understanding of both basic and complex medical concepts.
Knowledge of clinical research study design principles and statistical analysis methods.
Extensive knowledge of Good Clinical Practice (GCP) and US regulations for clinical trials.
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