Senior Clinical Research Associate

About the Role

This position is accountable for managing clinical study projects and study sites from the phase of site selection and initiation through to study monitoring and eventual close-out. The role requires adherence to Tigermed or sponsor SOPs, International Conference on Harmonization Good Clinical Practice standards (ICH-GCP), and other relevant regulations. It is essential that all data generated at assigned sites meet high-quality standards, are submitted on schedule, and remain within budget.

Primary Responsibilities

• Oversee selection, initiation (SIV), and monitoring of study sites ensuring suitability based on sponsor criteria including available resources and personnel expertise.
• Conduct pre-study visits to confirm site eligibility and capacity.
• Train site staff during initiation visits, ensuring thorough understanding of protocols and compliance requirements.
• Monitor compliance of Principal Investigators and study personnel with safety reporting regulations as outlined by protocols and GCP.
• Track recruitment rates to ensure enrollment goals are met across studies.
• Implement monitoring visits per SDV plans and SOPs, resolve site issues promptly, and prepare monitoring reports in a timely manner.
• Coordinate timely delivery of study materials, including investigational drugs, devices, and case report forms.
• Prepare and submit ethical committee documentation specific to each site.
• Provide ongoing training on ICH-GCP, study protocols, and procedural standards.
• Manage collection, maintenance, and archiving of essential regulatory documents through all study phases.
• Ensure safety data dissemination and SAE reporting adhere to SOPs and regulations.
• Manage study budgets and contractual agreements prior to site initiation and oversee payment schedules with proper documentation.
• Maintain and update study tools and systems efficiently.

Qualifications

• Bachelor's degree or higher in Medicine, Pharmacology, Biology, or related fields.
• Minimum of three years' experience as a Clinical Research Associate.
• Strong knowledge of GCP standards and clinical trial operational procedures.
• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook.