Clinical Research Associate I 
This CRA will be primarily responsible for ensuring site compliance with specified research protocols and the accuracy of submitted data. The CRA will also be responsible for maintaining proper written documentation for the study records of all site interactions.
Responsibilities:
Key Interfaces:
Basic Qualifications:
Preferred/Desired Qualifications:
This CRA will be primarily responsible for ensuring site compliance with specified research protocols and the accuracy of submitted data. The CRA will also be responsible for maintaining proper written documentation for the study records of all site interactions.
Responsibilities:
- Presentation and training of clinical investigation plans (CIP) to site personnel, including investigators.
- Assessing the suitability of facilities at a study center.
- Acting as liaison to study center staff.
- Monitoring site’s conduct of CIPs.
- Source data/document verification and ensuring that source documentation meets FDA/GCP/ICH requirements.
- Collect data and CRF from sites
- Writing visit reports on the conduct of the CIP at each center.
- Initiating and Closing study sites
- Accounting of study related materials issued to study sites
- Filing and archiving site documentation
- Assist with other clinical research related duties as required, which may include representation on cross functional teams, preparation of regulatory submissions, document review, internal auditing. Advisory meeting preparation, etc.
Key Interfaces:
- Study investigators and study coordinators.
- Colleagues from Clinical and Regulatory Affairs.
- Project team members from Engineering, Manufacturing, Sales & Marketing, Quality etc.
Basic Qualifications:
- Great and consistent attention to detail and follow through on commitments
- Bachelor’s degree required, preferably in the life sciences, engineering,
- 1+yr Experience as Clinical Research Associate or 2+ years as Clinical Research Coordinator
- Proficient knowledge of MS Office Applications (Word, Excel, Powerpoint, Etc)
- Fundamental knowledge and good understanding of GCP’s, clinical study development process, and logistics.
- Fluency in written and spoken English.
- Excellent written and verbal communication skills.
- Excellent interpersonal, judgment, and time management
- Travel – 50-75% travel.
Preferred/Desired Qualifications:
- Proficient knowledge of interventional cardiology procedures and terminology.
- Prior experience executing interventional cardiology research studies.
- Prior experience working in a regulated environment
- CRA certification (ACRP/SOCRA) or eligible to take certification exam