BrioHealth Solutions is looking to add to our growing team. We are looking for Clinical Research Associates (CRA) who are looking to help bring our novel LVAS device to the market. The ideal candidate will be well versed in clinical trial management, where you will be helping manage the data collected during clinical trials. We are looking for an inhouse CRA II (CRA II) The essential duties and responsibilities of the role is described below: 

Responsibilities:

• The CRA II s required to be able to perform all CRA I activities, with the following additional duties and responsibilities.
• Performing pre-study visits, including but not limited to Site Qualification Visits(SQV) and Site Initiation Visits(SIV).
• Developing and maintaining close relationship with sites to monitor clinical study through:

o Visiting the study sites or performing remotely (or both)
 o Verifying that data entered on to the CRFs is consistent with participant clinical notes, known as
 o Closing out of study centers on completion of the trial or for other reasons (close out visits)
 o Writing accurate and timely visit reports in accordance with the monitoring plan
 o Overseeing device accountability

• Be able to independently perform submissions, or preparations for site submissions, to Institutional Review Boards (IRBs) / Ethics Committees (ECs) and Regulatory Authorities and follow up till approval is obtained
• Oversee the distribution and management of inventory of clinical trial supplies ensuring that device accountability requirements are adhered to
• Independently prepare annual trial progress reports for IRBs/ECs and Regulatory Authorities
• Assist sites with reporting Serious Adverse Event to IRBs/ECs and Regulatory Authorities and investigators.
• Independently perform User Acceptance Testing of EDC
• Independently manage electronic tools such as CTMS or eTMF systems
• Independently prepare study related training materials
• · Provide input for updates of SOPs and drafting of new quality documentation
• Assist in giving on-the-job training and instructions to CRA I level team members and support any co-monitoring requirements as requested by the CRA III

Required Qualifications:

• B.S. or higher degree in a science related field, or equivalent industry experience
• Ability to create, implement and evaluate operational and administrative processes
• Knowledge of US FDA CFR and guidelines applicable to conducting clinical trials (i.e. GCP certification or similar)
• Proficient in the use of computer and software systems
• Ability to understand basic and complex medical details
• Knowledge of principles of clinical research study design and approaches to statistical analysis
• Strong knowledge of Good Clinical Practice (GCP) and US regulations for clinical trials
• At least 3 years of Clinical Research experience in medical device clinical trials
• Able to travel extensively (>50%)

About BrioHealth Solutions Inc

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.