Lead Clinical Research Associate

The Lead Clinical Research Associate is a critical core team member responsible for the oversight of a defined set of clinical trial sites within a region. They oversee clinical trial sites to ensure compliance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), and local regulations. They serve as the primary point of contact for the site and act as the primary liaison between the site and my client. The CRA will conduct site visits, oversee essential document collection and review, and prepare trip reports to summarise monitoring activities.

Essential Functions of the job:

• Performs site qualification, site initiation, interim monitoring, site management and close-out visits (performed on-site or remotely) ensuring regulatory, ICH GCP, protocol, and company SOP compliance.
• Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions.
• Identifies potential factors which might affect subject safety and clinical data integrity, immediately communicates/escalates serious issues to the project team and develops action plans.
• Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes.
• Verifies site processes to obtain informed consent have been adequately performed and documents for each subject.
• Assesses site processes, conducts source document review, and verifies site compliance with data entry requirements according to the Monitoring Plan.
• Performs Source Data Review/Source Data Verification for assigned clinical trial sites.
• Reviews investigational product inventory, reconciliation and storage at trial sites, ensuring GCP guidelines are followed.
• Reviews the Investigator Site File for accuracy and completeness.
• Provides site and regional metrics into trackers to support project-level report generation.
• Understands project scope, budgets, and timelines for own activities in the clinical operations team; manages site-level activities/communication to ensure project objectives, deliverables and timelines are met.
• Ensures all assigned sites and project-specific site team members are trained and compliant with applicable requirements.
• Prepares for and attends Investigator Meetings and/or sponsor face-to-face meetings.
• Provides guidance at the site level towards audit readiness standards and supports preparation for audit and required follow-up actions.

Qualifications:

• Minimum of 4 years of Clinical Monitor/CRA experience in a biotech, pharmaceutical, or CRO capacity.
• B.S., scientific or healthcare degree preferred.
• Strong understanding of clinical trial processes and regulatory requirements, including ICH GCP guidelines.
• Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
• Excellent organisational and communication skills.
• Ability to work collaboratively in a fast-paced, dynamic environment.
• Demonstrated ability to manage multiple tasks simultaneously and to adapt to changing priorities to meet deadlines.

Computer/Technology Skills:

• Proficient with Microsoft Office Suite, Project Management tools.
• Understanding of clinical trial systems, including EDC, IRT, CTMS, and TMF platforms, is a plus.