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Clinical Research Associate II
2 months ago
**Company Overview:** AL Solutions is a leading provider of clinical research services, partnering with innovative biotech companies to advance medical research.
**Position Summary:** We are seeking an experienced Clinical Research Associate II to oversee and monitor clinical trials at investigational sites, ensuring compliance with regulatory requirements and industry guidelines.
**Key Responsibilities:**
- Conduct site visits to verify protocol compliance and collect data, ensuring accurate and timely reporting.
- Perform source document verification and data review to ensure data integrity and quality.
- Ensure completion of study documentation and regulatory filings, maintaining compliance with industry standards.
- Build strong relationships with site personnel and investigators, fostering a collaborative environment.
- Address site-related issues that may impact study conduct, providing timely solutions and support.
- Assist in site selection and qualification, ensuring alignment with company goals and objectives.
- Collaborate with Data Management to ensure accurate data reporting and analysis.
- Stay updated on industry guidelines and regulations, applying knowledge to ensure compliance and best practices.
**Requirements:**
- Bachelor's degree in a scientific or healthcare-related discipline, such as biology, chemistry, or pharmacology.
- Minimum 2 years of experience as a Clinical Research Associate in a CRO or pharmaceutical setting, with a strong understanding of ICH-GCP guidelines and regulatory requirements.
- Experience in site monitoring and visits, with a proven track record of ensuring compliance and data quality.
- Strong communication and interpersonal skills, with the ability to build relationships with site personnel and investigators.
- Detail-oriented and organized, with the ability to multitask and prioritize tasks effectively.
- Proficient in computer skills and data management systems, with the ability to analyze and interpret data.
- Willingness to travel to investigational sites, with a valid driver's license and ability to meet travel requirements.
**Benefits:**
**Competitive Salary and Benefits Package**
**Opportunities for Professional Growth and Development**
**Collaborative and Dynamic Work Environment**
