Associate Researcher

Position Summary

We are seeking a dedicated Associate Researcher to oversee and support clinical research site management and monitoring activities. This position ensures that clinical trials adhere strictly to protocols, regulatory standards, and industry best practices while maintaining exceptional data integrity and site compliance.

Key Responsibilities

• Conduct comprehensive site monitoring including site selection, initiation, periodic monitoring visits, and close-out processes per protocol and regulations.
• Assist research sites in participant recruitment strategies and oversee recruitment progress aligned with project schedules.
• Facilitate protocol training and study-related instruction for assigned sites, maintaining consistent communication to manage study progress and address operational issues.
• Assess site adherence to study protocols, Good Clinical Practice (GCP), and regulatory mandates, escalating any quality concerns promptly.
• Monitor critical study milestones such as regulatory submissions, participant enrollment, case report form completion, and resolution of data queries.
• Ensure accuracy and completeness of essential study documentation within Trial Master Files (TMF) and Investigator Site Files (ISF).
• Generate monitoring reports, conduct follow-up communications, and prepare other required study documentation.
• Work collaboratively with cross-disciplinary study teams to facilitate efficient project execution.
• Support recruitment planning and tracking at site level as needed.
• Assist with financial management for study sites, including invoice processing according to study agreements when applicable.

Qualifications

• Bachelor's degree in scientific, life sciences, healthcare, or equivalent educational background combined with relevant experience.
• Prior experience in clinical research monitoring or completion of Clinical Research Associate (CRA) training program preferred.
• Familiarity with Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and clinical research regulatory frameworks.
• Knowledge of clinical trial protocols and therapeutic areas.
• Proficient with Microsoft Office Suite (Word, Excel, PowerPoint).
• Strong communication skills, both written and verbal.
• Excellent organizational, analytical, and problem-solving skills.
• Effective time management with keen attention to detail.
• Adept at fostering productive relationships with internal teams, clinical sites, and external partners.