Lead Clinical Research Associate

Lead Clinical Research Associate

The Lead Clinical Research Associate (LCRA) performs site management and re-monitoring activities for assigned legacy studies to ensure that previous monitoring work complies with the study-specific Monitoring Plan, protocol, standard operating procedures, ICH GCP, and applicable regulatory requirements. This role provides leadership, subject matter expertise, and operational support to investigative sites and study teams, particularly for re-monitoring activities where previous site staff or study team members may no longer be available.

The LCRA evaluates prior CRA activities, reviews monitoring visit reports, identifies quality and compliance risks, supports remediation and CAPA activities, and communicates key issues and trends to the Clinical Trial Manager and broader management team.

Responsibilities:

• Perform site management and re-monitoring activities for assigned legacy clinical studies to ensure compliance with protocols, monitoring plans, SOPs, and regulatory requirements.
• Review previous monitoring activities, including monitoring visit reports, protocol deviations, and site-level compliance, to assess the adequacy and quality of prior oversight.
• Conduct detailed source data review and verification as appropriate, including chart review, to confirm data accuracy, completeness, and alignment with source documentation.
• Review informed consent documentation to ensure proper consent processes, version control, and adherence to regulatory and ethical requirements.
• Perform comprehensive TMF/eTMF, ISF, and essential document reviews, including regulatory binder review and reconciliation, to support inspection readiness.
• Identify quality, compliance, and inspection-readiness risks at both site and study levels, and document findings in a clear and structured manner.
• Support remediation activities by providing evidence-based recommendations and working with study teams and sites to address identified issues.
• Conduct on-site and remote re-monitoring visits, providing ongoing site support and guidance on corrective and preventive actions.
• Track findings, deviations, and issues arising from re-monitoring activities and support the implementation and follow-up of CAPA plans.
• Escalate significant issues, risks, and trends to the study team, Clinical Trial Manager, and management as appropriate, ensuring timely communication and resolution.
• Maintain study trackers, logs, and documentation to support project oversight, audit trails, and regulatory inspection readiness.
• Apply senior monitoring and oversight expertise across site management, re-monitoring, CAPA support, TMF/ISF reconciliation, and risk management activities.
• Contribute to legacy-study remediation initiatives by ensuring that historical data, documentation, and processes meet current quality and compliance expectations.
• Travel regionally within the USA, as required (up to approximately 70%), to perform on-site visits and provide direct site support.

Essential

Skills:

• Previous experience reviewing monitoring visit reports, with the ability to assess the quality and adequacy of prior monitoring activities.
• Proven ability to provide clear, evidence-based remediation recommendations based on review of historical monitoring activities and documentation.
• Strong capability to identify quality and compliance risks and to recommend and support appropriate remediation and CAPA activities.
• Advanced TMF/eTMF and ISF inspection-readiness expertise, including regulatory binder review and reconciliation.
• Proficiency with Microsoft Office applications, including Excel, and experience with CTMS and clinical trial systems.
• Ability and willingness to travel regionally within the USA up to approximately 70%.
• Minimum 7 years of clinical research experience, including at least 5 years of hands-on on-site monitoring experience.
• Minimum 2 years of monitoring oversight experience, including on-site oversight visits.
• Hands-on experience conducting site qualification visits (SQV), site initiation visits (SIV), interim monitoring visits (IMV), and close-out visits (COV).
• Advanced TMF/eTMF inspection readiness and CAPA management experience.
• Neurology clinical trial experience and Phase 13 clinical trial experience.
• Strong knowledge of ICH GCP, applicable regulations, and ICH E6(R3).

Additional Skills &

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, or a related field.
• Legacy study re-monitoring experience (preferred).
• PET or MRI trial experience (strongly…