Clinical Research ociate CRA

1 month ago


Dallas Center, United States Cedent Consulting Inc Full time

This is a remote position.

Position: Clinical Research ociate (CRA) Cardiovascular
Location: Remote (applicant should be willing to travel as needed)

Job Overview:

We are seeking a dedicated and detailoriented Clinical Research ociate (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 onsite and remote monitoring visits to ess study compliance patient safety and data integrity.
  • Site Management: Collaborate with site staff to facilitate the successful 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.
  • Doentation: Maintain thorough doentation 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 doentation.
  • Study Coordination: ist in the preparation and submission of regulatory doents ethics committee submissions and study materials.
  • Collaboration: Work closely with crossfunctional 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: Indepth understanding of cardiovascular diseases and related clinical trial odologies.
  • Ss:
    • Strong organizational and time management ss.
    • Excellent verbal and written communication abilities.
    • Proficient in data management and ysis tools.
    • Ability to work independently and as part of a team.


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

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

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