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
Seniority level
Associate
Employment type
Full-time
Job function
Research, Analyst, and Information Technology
Industries
Primary and Secondary Education and Non-profit Organizations
Referrals increase your chances of interviewing at AL Solutions by 2x