Job Description

Roles: The Lead CRA will assist with an immediate backlog of clinical monitoring trip report reviews. This role will serve as a quality oversight partner, evaluating CRA performance, ensuring monitoring quality, and supporting the development of monitoring processes and standards.

Candidates must reside within close proximity to a major airport to support regional travel.

Key Responsibilities

• Review, audit, finalize, and clear a backlog of clinical monitoring trip reports to ensure documentation quality, completeness, and compliance.
• Conduct Accompanied Monitoring Visits (AMVs) to assess Clinical Research Associate (CRA) monitoring performance, protocol knowledge, site management, and adherence to Good Clinical Practice (GCP).
• Evaluate CRA monitoring activities to ensure compliance with study protocols, Clinical Monitoring Plans (CMPs), Standard Operating Procedures (SOPs), and applicable regulatory requirements.
• Identify monitoring gaps, protocol deviations, and quality issues, and provide constructive feedback and recommendations for improvement.
• Document findings, complete oversight reports, and track follow-up actions resulting from AMV assessments.
• Support the planning, execution, documentation, and continuous improvement of the AMV program.
• Collaborate with Clinical Operations and Quality teams to enhance monitoring quality and consistency.
• Contribute to the development, review, and refinement of Clinical Monitoring Plans (CMPs) and monitoring Standard Operating Procedures (SOPs), as needed.
• Maintain high standards of data integrity, inspection readiness, and regulatory compliance.

Required Qualifications

• Bachelor's degree in Life Sciences or a related discipline, or equivalent combination of education and experience.
• Significant experience as a Clinical Research Associate (CRA), Clinical Quality professional, Clinical Trial Manager, or similar role within the pharmaceutical, biotechnology, or CRO industry.
• Demonstrated experience monitoring or auditing Central Nervous System (CNS) clinical trials.
• Experience conducting Accompanied Monitoring Visits (AMVs), co-monitoring visits, or other CRA oversight and assessment activities.
• Strong knowledge of ICH-GCP guidelines, FDA regulations, and clinical trial monitoring best practices.
• Experience reviewing monitoring documentation, including trip reports, for quality and compliance.
• Excellent written and verbal communication skills with strong attention to detail.
• Ability to manage multiple priorities in a fast-paced environment while meeting quality expectations.

Preferred Qualifications

• Experience supporting studies in Major Depressive Disorder (MDD) and/or Generalized Anxiety Disorder (GAD).
• Familiarity with CNS efficacy rating scales, including:
• Hamilton Anxiety Rating Scale (HAM-A)
• Montgomery-Åsberg Depression Rating Scale (MADRS)
• Experience authoring or revising Clinical Monitoring Plans (CMPs) and monitoring Standard Operating Procedures (SOPs).
• Experience supporting inspection readiness and clinical quality initiatives.

Travel Requirements

• Minimal travel initially while supporting the trip report review backlog.
• Regional travel is expected to increase as the AMV program expands and may reach up to 80% based on business needs.
• Every effort will be made to keep travel primarily within the assigned geographic region.

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