What are the responsibilities and job description for the Clinical Research Associate (CRA) position at Exero Medical?
We are seeking a resilient and meticulous Clinical Research Associate to join our team at Exero Medical Inc. The ideal candidate will be well-versed in clinical trial management, and rigorous, detail-oriented, and precise in their analysis reports.
Objectives of this role:
- Support execution of Exero’s clinical program in the United States
- Ensure compliance with protocols, standard operating procedures, and Good Clinical Practice (GCP) guidelines.
- Conduct regular site visits throughout the United States to monitor trial activities and data collection.
- Review and analyze clinical trial data for accuracy and completeness.
Your tasks:
- Conduct source data verification and ensure data quality.
- Manage trial supplies and investigational product accountability.
- Provide training to study staff on study protocols and GCP guidelines.
- Regular communication and coordination with clinical trial sites related to patient enrollment, data collection, monitoring, and other trial-related activities
- Regular communication and coordination with Exero’s global clinical and R&D team
Required skills and qualifications:
- Bachelor's degree in life sciences or related field
- Minimum 2 years work experience with at least 1 year of experience in a similar role.
- Knowledge of regulatory requirements and guidelines, such as Good Clinical Practice (GCP) and International Council for Harmonization (ICH).
- Certification in clinical research, such as the Association of Clinical Research Professionals (ACRP) certification.
- Knowledge of clinical trial data management systems and electronic data capture.
- Experience with site selection, initiation, management, source data verification, and monitoring activities.
- Strong attention to detail and accuracy in data management.
- Exceptional communication skills
Preferred skills and qualifications:
- Working knowledge of medical terminology and anatomy.
- Experience in the medical devices industry.
- Experience in clinical trials data management.
- Excellent project management and leadership skills with attention to detail.
- Ability to work collaboratively with study teams and cross-functional departments globally.
Exero Medical's mission is to empower health care providers with high-quality, actionable post-operative data that can save lives, improve prognosis, and reduce cost of care. The company's flagship product, the xBar system, has been granted Breakthrough Device Designation by the FDA. Exero Medical was founded in 2018 and is based in the United States and Israel.
Salary : $60,000 - $90,000