Clinical Research Associate II

About the Company

PSI is a prominent Contract Research Organization boasting over three decades of experience. The company is recognized for striking an ideal balance between stability and innovation, benefiting both its clients and employees. PSI emphasizes delivering high-quality and punctual services across numerous therapeutic areas.

Job Overview

In the role of Clinical Research Associate II, you will undertake diverse monitoring responsibilities on clinical trials spanning various therapeutic disciplines. You will ensure adherence to the industry's top quality standards throughout your assignments.

Key Responsibilities

• Serve as the primary liaison among the project team, sponsor, and clinical study sites.
• Establish and maintain positive relationships with clinical site personnel engaged in the study.
• Prepare for and execute site selection, initiation, routine monitoring, and close-out visits, providing detailed reports.
• Monitor and confirm that participant recruitment targets are defined, communicated, documented, and achieved timely, while ensuring site-level project deadlines are met.
• Facilitate accurate and swift communication of adverse events and protocol/process deviations from trial sites.
• Conduct source data verification and resolve data queries at the site; assess and manage site-specific study risks.
• Oversee the handling, accountability, usage, reconciliation, and return of investigational products and clinical supplies at sites.
• Review essential clinical study documentation and reconcile Investigator Site Files and Trial Master Files at the site level.
• Maintain quality through data integrity and compliance adherence at clinical sites.
• Conduct site audit preparation visits and assist in addressing audit findings.
• Participate as needed in site audits and client visits.
• Manage document and supply flow between project teams, sites, laboratories, reviewers, and warehouses.
• Deliver project-specific training to site investigators.
• Assist in preparing Investigator newsletters.
• Support Site Management Associates in maintaining site and corporate tracking systems.
• Contribute to the development of regulatory and ethics committee submission packages.
• Facilitate collection of IP-RED packages at site and country levels.
• Help review and reconcile Trial Master Files at country and site levels.

Required Qualifications

• College or university degree in Life Sciences or equivalent education, training, and experience.
• Preferred residence in the Central or West Coast regions of the United States.
• At least two years of independent on-site clinical monitoring experience.
• Proficiency in conducting all types of monitoring visits spanning Phase I to III clinical trials.
• Mandatory experience in oncology clinical trials; gastrointestinal or radiopharmaceutical experience is preferred.
• Full professional proficiency in English.
• Competency with MS Office tools.
• Capability to plan, multitask, and effectively collaborate within a dynamic team environment.
• Strong communication, teamwork, and problem-solving skills.
• Willingness and ability to travel up to 75% of the time.
• Possession of a valid driver’s license if applicable.

Additional Details

This position offers an excellent chance to enhance your professional skills, expand your expertise in various therapeutic areas, and establish yourself as an authority in clinical research.

Note: Candidates requiring work authorization through a visa now or in the future will not be considered for this role by PSI.