Clinical Research Associate II

1 week ago

Seattle, Washington, United States AL Solutions Full time
Job Title: Clinical Research Associate II (CRA II)

**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 study objectives.
  • Collaborate with Data Management for accurate data reporting, ensuring seamless data integration.
  • Stay updated on industry guidelines and regulations, applying knowledge to ensure compliance.

**Requirements:**

  • Bachelor's degree in a scientific or healthcare-related discipline, such as biology, chemistry, or pharmacology.
  • Minimum 2 years of CRA experience 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 focus on data collection and verification.
  • Strong communication and interpersonal skills, with the ability to build relationships with site personnel and investigators.
  • Detail-oriented and organized, with multitasking abilities and a focus on accuracy and quality.
  • Proficient in computer skills and data management systems, with experience in data analysis and reporting.
  • Willingness to travel to investigational sites, with a flexible schedule and ability to adapt to changing circumstances.

**Benefits:**

**Competitive Salary**

**401k Plan**

**Professional Development Opportunities**

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