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
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