Clinical Research Associate

Integrated Resources Inc.; San Jose (CA); On-site; USD 85,000 - 120,000; Full time

Job summary

Integrated Resources Inc. is seeking a Clinical Data Manager in San Jose, California. The ideal candidate will lead clinical studies, ensuring data quality and integrity while collaborating with various professionals. This role requires strong leadership skills, a deep understanding of data management processes, and familiarity with FDA regulations.

Qualifications

• Experience in Academic CRO and clinical trials.
• Understanding of FDA regulations and regulatory submissions.
• Ability to collaborate with various stakeholders and ensure data quality.

Responsibilities

• Lead 3-4 studies and ensure data completeness and correctness.
• Support routine clinical data management and CRF/eCRF preparation.
• Identify and resolve routine queries while monitoring study progress.

Skills

Leadership

Problem-solving

Data management

Tools

Clinical data management systems

Web-based EDC

Job description

IRI believes in commitment, integrity, and strategic workforce solutions.

Integrated Resources, Inc., is led by a seasoned team with decades of industry experience. We deliver strategic workforce solutions that help manage talent and business efficiently. Since 1996, IRI has attracted and retained experts in various fields, expanding into new sectors and growing steadily.

We focus on finding qualified professionals in our specialty areas. Our partner-employers trust us to match their needs with top-tier candidates. By exceeding expectations, we build long-term partnerships rooted in performance and integrity.

Our team provides tailored solutions for each client, ensuring the right match between employers and candidates, aligned in skills and culture. At IRI, our success depends on our clients’ success.

Job Description

We are seeking a candidate with experience in Academic CRO, capable of leading 3-4 studies. The candidate should understand data management and documentation processes, and have worked on clinical trials as a clinical data manager, CRF design, or clinical data management plan. Responsibilities include collaborating with Clinical Programmers, CRAs, Statistical Programmers, Biostatisticians, and other staff to meet project timelines for data acquisition, quality checks, and reporting.

The candidate should demonstrate understanding of assigned protocols, critical tasks, and milestones. Ensuring the completeness, correctness, and consistency of clinical data and data structures is essential. The role involves supporting routine clinical data management with vendors, including data entry, quality checks, transfer, reporting, backup, and recovery. Assisting in CRF/eCRF preparation for regulatory approval, reviewing study protocols, and supporting site staff in data collection are also key duties.

The candidate must identify, track, and resolve routine queries, utilize reports to monitor study progress, and ensure timely, high-quality deliverables. Leadership and problem-solving skills are required, along with knowledge of FDA regulations, regulatory submissions, and familiarity with web-based EDC and clinical data management systems.

Additional Information

Regards,