CRA/Sr CRA - Client decicated (FSP)

Work Schedule

• Standard Monday through Friday schedule.

Work Environment

• Office-based work environment with remote and onsite clinical monitoring visits.

Role Overview

Clinical Monitoring Duties

• Monitor investigator sites using risk-based monitoring, root cause analysis, critical thinking, and problem-solving.
• Review source data, source documents, case report forms, investigational product inventories, and site records.
• Document observations, escalate deficiencies, and follow issues through resolution.
• Maintain contact with sites between visits to confirm protocol compliance and timely data recording.
• Participate in investigator meetings, site selection, site initiation, trial closeout, and retrieval of trial materials.
• Ensure essential documents are complete and conduct onsite file reviews.
• Track trial status, provide progress updates, and maintain clinical trial management systems.
• Facilitate communication among investigative sites, the client company, and the project team.
• Respond to regulatory requirements, audits, and inspections.
• Complete expense reports and timesheets and contribute to project improvements.

Education and Experience

• Bachelor's degree in a life sciences-related field, registered nursing certification, or equivalent relevant qualification.
• Comparable experience of approximately one year as a clinical research monitor or completion of the PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• Demonstrated clinical monitoring skills and knowledge of medical or therapeutic areas and medical terminology.
• Working knowledge of ICH-GCP, applicable regulations, and procedural documents.
• Well-developed critical thinking and problem-solving skills.