CRA/Sr CRA - Client decicated (FSP)

Work Schedule

• Standard work schedule is Monday through Friday.

Environmental Conditions

• The listed environmental condition is office-based.
• The role includes remote or on-site visits to investigator sites.

Role Overview

Clinical Monitoring

• Monitor investigator sites using a risk-based monitoring approach.
• Apply root cause analysis, critical thinking, and problem-solving to identify site process failures and corrective or preventive actions.
• Assess data accuracy through source data review, source data verification, and case report form review as applicable.
• Assess investigational product through physical inventory and records review.
• Document observations in reports and letters and escalate deficiencies through resolution.
• Maintain contact with investigative sites between monitoring visits to confirm protocol compliance and timely issue resolution.
• Conduct monitoring tasks according to the approved monitoring plan and participate in investigator payment processes.

Site and Trial Management

• Identify potential investigators and initiate clinical trial sites according to relevant procedures.
• Perform trial closeout and retrieval of trial materials.
• Ensure essential documents are complete and conduct on-site file reviews.
• Provide trial status tracking and progress updates to the Clinical Team Manager.
• Keep study systems updated according to agreed study conventions, including clinical trial management systems.
• Facilitate communication between investigative sites, the client company, and the project team.
• Respond to company, client, and regulatory audits or inspections.
• Complete expense reports and timesheets and contribute to project tools and process improvement initiatives.

Education and Experience

• Bachelor's degree in a life sciences-related field, or Registered Nursing certification or an equivalent relevant academic or vocational qualification.
• Previous experience comparable to one year as a clinical research monitor or completion of the PPD Drug Development Fellowship.
• Valid driver's license where applicable.
• An equivalent combination of appropriate education, training, and directly related experience may be considered.

Knowledge, Skills and Abilities

• Proven clinical monitoring skills.
• Understanding of medical or therapeutic areas and medical terminology.
• Working knowledge of ICH-GCP guidelines, applicable regulations, and procedural documents.
• Critical thinking, problem-solving, and root cause analysis skills.