Clinical Research Associate (CRA) - Cadiovascular Job at Cedent Consulting Inc, Dallas, TX

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  • Cedent Consulting Inc
  • Dallas, TX

Job Description

Job Description

Job Description

This is a remote position.

Position: Clinical Research Associate (CRA) Cardiovascular

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

Job Overview:

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.

Key Responsibilities:
  • 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.
Qualifications:
  • 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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