Associate Researcher

Job Summary

We are looking for a Research Associate to support the oversight and management of clinical research sites. This position ensures that clinical trials adhere to study protocols, regulatory standards, and industry guidelines, while upholding excellent data quality and site compliance.

Key Responsibilities

• Perform site monitoring tasks such as site selection, initiation, routine visits, and close-outs aligned with study protocols and regulations.
• Assist study sites with planning participant recruitment and track recruitment progress to meet study timelines.
• Provide training on protocols and study requirements to sites and maintain ongoing communication to resolve study and operational challenges.
• Assess site adherence to study protocols, Good Clinical Practice (GCP), and regulatory mandates, escalating any quality issues as necessary.
• Monitor key study milestones including regulatory filings, approvals, patient enrollment, case report form completion, and resolution of data queries.
• Ensure that critical documentation is complete, precise, and properly stored in the Trial Master File and Investigator Site File.
• Generate monitoring reports, follow-up letters, and other essential study documents.
• Work closely with multidisciplinary teams to aid successful execution of projects.
• Participate in recruitment planning and tracking efforts at the site level when required.
• Support financial administration at sites, including invoice processing in accordance with study agreements when applicable.

Qualifications and Skills

• Bachelor's degree in scientific, life sciences, healthcare, or a related field preferred; equivalent experience considered.
• Experience in clinical research monitoring or completion of a Clinical Research Associate training program is desirable.
• Familiarity with Good Clinical Practice (GCP), ICH guidelines, and clinical research regulatory frameworks.
• Understanding of clinical protocols and various therapeutic areas.
• Proficient with Microsoft Office suite including Word, Excel, and PowerPoint.
• Strong communication skills, both verbal and written.
• Excellent organizational, analytical, and problem-solving capabilities.
• Effective time management and meticulous attention to detail.
• Ability to develop and sustain effective collaborative relationships with internal teams, clinical sites, and external partners.