Senior Clinical Research Associate I

Overview

As a Senior Clinical Research Associate I, you drive site management and monitoring to deliver safe, compliant, and high-quality clinical trials. You partner with the Site Care Partner and study team to ensure site activation through database lock, timely issue resolution, and robust patient safety measures. You will coach investigators and staff, oversee regulatory adherence, and maintain strong external relationships to advance trial goals. This role offers the opportunity to influence trial execution on a global scale within a patient-centric, quality-driven culture.

Pay / Benefits

• remote work
• flexible workplace culture
• significant travel opportunities
• diversity and inclusion commitments
• Disability Confident employer
• career development opportunities

Responsibilities

• Manage investigator sites from activation to database lock, meeting timelines and quality standards
• Serve as primary site contact during study conduct and coordinate with SCP for site delivery quality
• Train and coach site personnel on protocol and risk management; address site questions
• Attend investigator meetings as needed and support recruitment initiatives at site level
• Conduct onsite/remote monitoring per Monitoring Plan; handle AE/SAE follow-up and regulatory reporting
• Identify and resolve site issues; implement corrective/preventive actions and closeout activities
• Ensure investigational product oversight at sites (receipt, storage, handling, accountability) and support database release
• Support sponsor regulatory interactions/inspections and manage audits
• Submit required trial master file documentation, site reports, deviations, and progress metrics on time
• Provide guidance to investigators on patient safety and eligibility; monitor data queries and study progress

Key requirements

• Bachelor’s degree in life sciences or professional degree in life sciences; Oncology experience preferred
• Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA and local regulations
• Minimum 3 years of clinical research site monitoring experience ( Oncology experience preferred)
• Global clinical trial experience and fluency in English (and local language as applicable)

• Strong communication and interpersonal skills
• Ability to work in a matrix team and influence across functions
• Problem-solving and proactive risk management
• ICH/GCP knowledge
• Clinical trial monitoring and data management
• AE/SAE assessment and regulatory reporting

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