Job Description

This is a remote position.

Position: Clinical Research Associate (CRA) Cardiovascular

Location: Remote (applicant should be willing to travel as needed)

We are seeking a dedicated and detail-oriented Clinical Research Associate (CRA) with a strong background in cardiovascular studies. The ideal candidate will play a crucial role in the management and monitoring of clinical trials, ensuring compliance with regulatory requirements, study protocols, and GCP guidelines.

• Study Monitoring: Conduct on-site and remote monitoring visits to assess study compliance, patient safety, and data integrity.
  
• Site Management: Collaborate with site staff to facilitate the successful execution of clinical trials, including training and support for site personnel.
  
• Data Review: Review and verify clinical data collected to ensure accuracy and adherence to protocols.
  
• Regulatory Compliance: Ensure that all clinical activities comply with FDA regulations, ICH guidelines, and institutional policies.
  
• Documentation: Maintain thorough documentation of monitoring visits, site communications, and any findings or issues.
  
• Adverse Event Reporting: Oversee the identification and reporting of adverse events, ensuring timely and accurate documentation.
  
• Study Coordination: Assist in the preparation and submission of regulatory documents, ethics committee submissions, and study materials.
  
• Collaboration: Work closely with cross-functional teams, including project managers, data managers, and medical monitors, to support study objectives.
  
• Training: Provide training and guidance to site staff on study protocols and procedures.
  

• Education: Bachelor’s degree in Life Sciences, Nursing, or a related field. Advanced degree preferred.
  
• Experience: Minimum of 2 years of experience as a CRA, with a focus on cardiovascular clinical trials.
  
• Knowledge: In-depth understanding of cardiovascular diseases and related clinical trial methodologies.
  
• Skills:
  • Strong organizational and time management skills.
    
  • Excellent verbal and written communication abilities.
    
  • Proficient in data management and analysis tools.
    
  • Ability to work independently and as part of a team.
    

Requirements

Certifications: CRA certification (e.g., ACRP, SOCRA) is preferred.

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