Job Description

Job Description

Job 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

And many more

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