Clinical Research Associate II - West or Pacific Northwest US - FSP

Parexel•United States-California-Remote, CA

About The Position

Parexel is seeking Clinical Research Associate IIs in the West or Pacific Northwest United States. The Clinical Research Associate II acts as the primary site contact and site manager throughout all phases of a clinical research study and takes overall responsibility for allocated sites. The role manages and monitors study sites in accordance with applicable Good Clinical Practice requirements, sponsor procedures, local laws and regulations, protocols, monitoring plans, and related documentation. The position builds and maintains site relationships, supports site readiness and selection, performs remote and on-site monitoring, and conducts site visits throughout the study lifecycle. It ensures study data are complete, accurate, and unbiased, and that subjects’ rights, safety, and well-being are protected. The CRA communicates with investigators and site staff, manages regulatory and study documentation in relevant systems, and identifies and resolves site performance, quality, or compliance issues. The role also contributes to CRA team development by sharing expertise and best practices, mentoring or acting as a subject matter expert, and supporting audits, inspections, and co-monitoring visits. The CRA is expected to work independently across multiple protocols, sites, and therapy areas, maintain compliance with Parexel and client requirements, and travel domestically and internationally approximately 65%–75% of working time, typically about two to three days per week.

Requirements

At least 2 years of direct site monitoring experience in biotech, pharmaceutical, or CRO settings.
Bachelor’s degree with a strong emphasis in science and/or biology.
Fluency in local languages and English, verbally and in writing, and excellent communication skills, including the ability to understand and present technical information effectively.
Good understanding and working knowledge of clinical research, clinical trial phases, current GCP/ICH requirements, and country clinical research laws and guidelines.
Good understanding of global and country/regional clinical research guidelines and ability to work within them.
Hands-on knowledge of Good Documentation Practices.
Proven site management skills, including management of site performance and patient recruitment.
Demonstrated high-level monitoring skills and independent professional judgment.
Good IT skills, including Microsoft Office and clinical IT applications on computers, tablets, and mobile devices, and ability to adapt to new applications.
Ability to understand and analyze data and metrics and act appropriately.
Ability to manage complex issues in a solution-oriented manner, perform root cause analysis, and implement preventive and corrective actions.
Effective time management, organizational, interpersonal, conflict management, and problem-solving skills.
Ability to work independently across multiple protocols, sites, and therapy areas.
High accountability and urgency, with the ability to prioritize and handle multiple tasks in a changing environment.
Ability to work effectively in a multicultural matrix environment and establish culturally sensitive working relationships.
Customer focus, a high-quality and compliance mindset, and a positive, growth-oriented, self-driven approach.
Professional demeanor and communication consistent with organizational policies and practices.
Ability to travel domestically and internationally approximately 65%–75% of working time, with expected travel of about two to three days per week.
Current driver’s license.

Responsibilities

Develop strong site relationships and ensure continuity of site relationships through all phases of a trial.
Perform clinical study site management and monitoring in compliance with ICH-GCP, sponsor SOPs, local laws and regulations, the protocol, the Site Monitoring Plan, and associated documents.
Develop an in-depth understanding of the study protocol and related procedures.
Coordinate and manage tasks with other sponsor roles to achieve site readiness.
Participate in and provide input on site selection and validation activities.
Perform remote and on-site monitoring and oversight to ensure site data are complete, accurate, and unbiased and subjects’ rights, safety, and well-being are protected.
Conduct validation, initiation, monitoring, and closeout visits, and prepare clear, comprehensive, and accurate visit and non-visit contact reports promptly.
Collect, review, and monitor regulatory documentation for study start-up, maintenance, and close-out.
Communicate with investigators and site staff about protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, audits and inspections, and site performance.
Identify, assess, and resolve site performance, quality, or compliance problems, escalating issues through the defined CRA Escalation Pathway as appropriate and in collaboration with the Clinical Research Manager and Partner Line Manager.
Maintain information and documentation in the Clinical Trial Management System, electronic Trial Master File, and other systems within required timelines.
Contribute to CRA team knowledge as a process subject matter expert or buddy/mentor and share best practices as appropriate.
Support or lead audit and inspection activities as needed and perform co-monitoring visits where appropriate.
Complete required training, timesheets, and expense reports, and update the CV as required.
Maintain working knowledge of and comply with Parexel and client processes, ICH-GCP, and other applicable requirements.