Senior Clinical Research Associate, Monitoring and Compliance Specialist
hace 4 semanas
About the Role:
We are seeking a skilled Senior Clinical Research Associate to join our team. As a key member of our organization, you will play a vital role in ensuring the successful execution of clinical studies.
Key Responsibilities:
- Conduct site-level monitoring visits, evaluations, and audits to ensure compliance with study protocols and regulations.
- Maintain accurate records and documentation, including site-specific information, audit reports, and quality control data.
- Collaborate with cross-functional teams to identify and address any issues or concerns that may impact study success.
- Develop and implement training programs for CRAs to enhance their skills and knowledge.
- Provide expert advice on local regulatory requirements and ensure adherence to federal regulations, GCPs, and AbbVie SOPs.
- Identify areas for process improvement and develop solutions to increase efficiency and effectiveness.
- Perform remote data review and provide feedback to investigators/sites based on site performance.
Requirements:
- Bachelor's degree in a health-related field (e.g., medical, scientific, nursing, pharmacy) preferred.
- Minimum 5 years of experience in site monitoring, with a strong understanding of clinical research and regulatory guidelines.
- Excellent analytical, problem-solving, and communication skills, with the ability to work effectively in a dynamic environment.
- Demonstrated business ethics and integrity, with a commitment to upholding the highest standards of professionalism.
Salary Information:
The estimated annual salary for this position is $85,000 - $110,000, depending on location and qualifications.
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