Senior Clinical Research Associate

Job Overview

As a Senior Clinical Research Associate (Level I), you will perform and coordinate all aspects of clinical monitoring and site management, including remote or on-site visits to assess protocol and regulatory compliance. You will manage procedures from various sponsors and environments, ensuring trials adhere to approved protocols, ICH-GCP guidelines, regulations, and SOPs to protect subjects’ rights, well-being, and data reliability. You will also ensure audit readiness and build collaborative relationships with investigational sites.

Responsibilities

• Monitor investigator sites using a risk-based approach, applying root cause analysis, critical thinking, and problem-solving to identify and resolve site process failures, ensuring compliance and reducing risks.
• Ensure data accuracy through source data review, source data verification, and case report form review via on-site and remote activities; assess investigational product inventory and document observations timely.
• Escalate deficiencies to clinical management, follow issues to resolution, maintain regular site contact, conduct monitoring per the approved plan, participate in investigator payments, and collaborate on issue resolution.
• Provide trial status updates to the Clinical Team Manager, update study systems like CTMS, perform QC checks on reports, and participate in investigator meetings.
• Identify and initiate clinical trial sites, ensure compliance with protocol and regulations, recommend improvements, manage trial close-out, and retrieve materials.
• Ensure essential documents are complete per ICH-GCP and regulations, and conduct on-site file reviews as specified.
• Contribute to the project team by assisting in preparation of project publications and tools.

Qualifications

• Previous experience providing knowledge, skills, and capabilities comparable to 2 years preferred; equivalency of education, training, and related experience may be considered.
• Adequate experience in neurology monitoring and/or oncology monitoring; strong advisory experience in rare disease and pediatric areas.