Senior Clinical Research Associate – FSP

Parexel

. Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols .

Posted 10/13/2026full-timeRemote • California • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical site monitoring, ensuring compliance with Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), and study protocols. Proven ability to collaborate with cross-functional teams, mentor junior staff, and implement effective patient recruitment and retention strategies.

Highest-signal resume keywords

Clinical Site MonitoringGood Clinical Practices (GCP)Oncology ExperienceMS Office 365 Proficiency5+ Years Monitoring Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research ExperienceRoot Cause AnalysisRisk-Based MonitoringSite AssessmentPatient Recruitment Strategies

Soft Skills

Excellent Communication SkillsStrong Organizational AbilitiesTeam CollaborationMentoring

Tools & Technologies

MS Office 365SharePoint

Industry Keywords

BiotechnologyPharmaceuticalContract Research Organization (CRO)Medical DeviceICH GuidelinesFDA Regulations

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Conduct and provide support for in-house and outsourced clinical site monitoring activities to ensure adherence to Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), and study protocols
Collaborate with study teams during start-up/feasibility and conduct site identification and assessment tasks
Identify root causes and proactively escalate and resolve CRA and site performance issues through collaboration with stakeholders
Provide monitoring expertise, mentoring, and training to less experienced team members as required
Build positive working relationships and proactively seek feedback from site teams, including Principal Investigators, Study Coordinators, Pharmacists, and Site Administration
Partner with study teams and sites on site outreach activities, including patient recruitment and retention strategies
Provide input and lead cross-functional teams in determining monitoring strategy, including risk-based monitoring
Use regional knowledge to localize study processes and documents where possible
Represent Monitoring at Investigator Meetings as required
Collaborate with study teams and stakeholders to conduct site assessments, identify performance issues, and implement solutions aligned with project goals and operational efficiency
Perform other tasks as required

Requirements

What you’ll need

Ability to travel domestically
Demonstrates ability to work independently and in a team environment
Proficiency with MS Office 365 (e.g., Word, Excel, PowerPoint, Outlook, SharePoint)
Excellent oral and written communication skills and strong organizational abilities
Relevant clinical research experience in biotechnology, pharmaceutical, Contract Research Organization (CRO), or medical device settings
Demonstrates working knowledge of GCP, ICH guidelines and FDA regulations
Experience in Oncology preferred
5+ years of relevant monitoring experience
BA/BS, nursing degree, or advanced degree
Degree in the life sciences preferred