Clinical Research Specialist

About the Company

BiVACOR is developing the world’s most advanced total artificial heart, a technology capable of saving millions of lives around the world.

Responsibilities

• Serve as key contact for Clinical Site Research Coordinators and ensure timely, accurate data entry into the eCRF
• Provide training to study staff on study protocols and GCP guidelines
• Develop and maintain study timelines and budgets
• Develop study documents and procedures, and conduct study site file (eTMF) maintenance reviews
• Review and maintain clinical trial documents and analyze clinical trial data for accuracy
• Perform investigational product (IP) inventory, reconciliation, and review of storage and security
• Ensure sites are conducting activities per protocol, HREC requirements, and executed contracts
• Provide frequent communication to study leadership on site status updates
• Work closely with the extended study team, including CROs, vendors, and trial staff
• Follow standard operating procedures and Good Clinical Practice (GCP) guidelines

Requirements

• Bachelor’s degree in a life science-related field
• 2–4 years of experience in a clinical trials research environment
• General knowledge of regulatory requirements (e.g. TGA, FDA) and GCP
• Proficient knowledge of medical terminology and clinical trial documentation (eTMF)
• Willingness to travel nationally and internationally up to 75%

Preferred Qualifications

• CCRA, ACRP, CCRP, or SOCRA certification

Benefits

• 401(k) with company matching
• Medical, dental, and vision insurance
• Health Savings Account (HSA) & Flexible Spending Account (FSA)
• Life insurance & Employee Assistance Program
• Generous paid time off