Clinical Research Associate II

4 weeks ago

Seattle, United States AL Solutions Full time
Job DescriptionJob Description

Company Overview: AL Solutions is partnered with a groing Biotech. With a focus on quality, innovation, and patient safety, our client is committed to driving excellence in clinical research.

Position Summary: We are currently seeking a dedicated and experienced Clinical Research Associate II (CRA II) to join our team. As a CRA II, you will be responsible for overseeing and monitoring clinical trials at various investigational sites in accordance with study protocols, Good Clinical Practice (GCP), and applicable regulatory requirements.

Responsibilities:

  • Conduct site initiation, interim monitoring, and close-out visits to ensure protocol compliance and high-quality data collection.
  • Perform source document verification, query resolution, and data review at study sites.
  • Ensure accurate and timely completion of monitoring reports, study documentation, and regulatory filings.
  • Develop and maintain strong relationships with investigators, site personnel, and study teams.
  • Identify and address any site-related issues or challenges that may impact study conduct or data integrity.
  • Assist with the selection and qualification of investigational sites, ensuring they meet study requirements and have adequate resources.
  • Collaborate with the Data Management team to ensure accurate and timely data collection and reporting.
  • Stay updated with relevant industry guidelines, regulations, and best practices.

Requirements

Qualifications and Experience:

  • Bachelor's degree in a scientific or healthcare-related discipline.
  • Minimum of 2 years of experience as a Clinical Research Associate, preferably in a CRO or pharmaceutical setting.
  • Strong understanding of ICH-GCP guidelines and regulatory requirements.
  • Demonstrated experience in site monitoring, including site initiation, interim monitoring, and close-out visits.
  • Excellent communication and interpersonal skills, with the ability to build and maintain relationships.
  • Detail-oriented and organized, with the ability to manage multiple tasks simultaneously.
  • Proficient computer skills, including knowledge of electronic data capture systems and clinical trial management systems.
  • Willingness to travel to investigational sites as required.

Benefits

401k

Competitive Salary

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