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Clinical Research Associate
1 month ago
Job Summary: We are seeking a dedicated Clinical Research Associate (CRA) to join our dynamic team. The CRA will play a pivotal role in managing and monitoring clinical trials to ensure compliance with regulatory requirements, study protocols, and quality standards. This position offers an opportunity to contribute to groundbreaking research while working closely with a multidisciplinary team.
Key Responsibilities:
- Study Management: Oversee and coordinate all aspects of clinical trials, including site selection, initiation, monitoring, and closeout activities.
- Site Monitoring: Conduct regular site visits to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements. Resolve any issues or deviations.
- Data Collection and Management: Ensure accurate and timely collection, recording, and reporting of clinical trial data. Review data for completeness and consistency.
- Regulatory Compliance: Maintain up-to-date knowledge of regulatory guidelines and ensure that all documentation and practices adhere to local, state, and federal regulations.
- Collaboration: Serve as a primary point of contact between the sponsor and clinical sites. Facilitate communication and support for site staff, including training and education on study protocols.
- Documentation: Prepare and review study-related documents, including informed consent forms, case report forms, and monitoring reports. Ensure proper filing and archiving of study documentation.
- Problem-Solving: Identify and address issues that may impact the progress or integrity of the study. Implement corrective and preventive actions as needed.
Qualifications:
- Education: Bachelor's degree in Life Sciences, Nursing, or a related field. Advanced degree or certification (e.g., Clinical Research Coordinator (CRC), Clinical Research Associate (CRA)) is a plus.
- Experience: Minimum of 2-4 years of experience in clinical research, including experience with site monitoring and regulatory compliance.
- Skills: Strong understanding of GCP, clinical trial processes, and regulatory guidelines. Excellent organizational, communication, and interpersonal skills. Proficiency in MS Office Suite and clinical trial management systems (CTMS).
- Other: Ability to travel to clinical sites as required. Strong attention to detail and problem-solving skills. Ability to work independently and as part of a team.
Benefits:
- Competitive salary and performance-based incentives
- Comprehensive health, dental, and vision insurance
- Retirement savings plan with company match
- Paid time off and holidays
- Professional development opportunities
