CRA/Sr CRA - Client decicated (FSP)

Role Overview

Responsibilities

• Monitor investigator sites using risk-based monitoring and investigate site process failures.
• Apply corrective and preventive actions, review trial data, and assess investigational product records.
• Document observations, escalate deficiencies, and follow issues through resolution.
• Maintain contact with investigative sites between monitoring visits.
• Participate in investigator meetings, site identification, site initiation, and trial closeout.
• Ensure essential documents are complete and conduct onsite file reviews.
• Provide trial status updates and maintain clinical trial management systems.
• Facilitate communication among sites, the client company, and the project team.
• Respond to company, client, and regulatory audits or inspections.
• Complete administrative tasks and contribute to project tools and process improvement.

Education and Experience

• Bachelor's degree in a life sciences-related field, Registered Nursing certification, or equivalent qualification.
• Comparable experience to one year as a clinical research monitor or completion of the PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• Equivalency through appropriate education, training, or directly related experience may be considered.

Knowledge and Skills

• Clinical monitoring skills and medical or therapeutic area knowledge.
• Working knowledge of ICH-GCP, applicable regulations, and procedural documents.
• Critical thinking, problem-solving, and root cause analysis skills.
• Ability to support data reliability, audit readiness, and collaborative site relationships.

Schedule

• The listed work schedule is standard Monday through Friday.

Workplace

• The role operates in an office environment and includes remote or onsite visits to investigator sites.