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.