Clinical Research Associate (CRA) - Cardiovascular ()

Position: Clinical Research Associate (CRA)
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.
• Certifications: CRA certification (e.g., ACRP, SOCRA) is preferred.

Department: Direct Clients
This is a contract position