Clinical Research Assistant

This is a fully remote position, open to applicants in United States.

📋 Description

• Facilitate the coordination and administration of clinical research studies, ensuring the integrity of study documentation, data quality, and adherence to regulatory standards throughout the research process.

• Aid in the daily management of assigned clinical studies.

• Maintain investigator site files, regulatory binders, and essential study documents.

• Prepare, review, and organize research documentation in compliance with study requirements.

• Assist in scheduling participants and coordinating study visits.

• Input, verify, and reconcile clinical data within electronic research systems.

• Track study timelines and help monitor project deliverables.

• Communicate efficiently with investigators, sponsors, study participants, and internal research teams.

• Detect and escalate documentation discrepancies or protocol deviations when necessary.

• Ensure research activities adhere to ICH Good Clinical Practice (GCP), study protocols, and relevant regulatory requirements.

• Carry out additional administrative and research support tasks as assigned.

⛳️ Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Nursing, Public Health, or a related field, or equivalent experience in healthcare.

• Strong organizational skills and problem-solving capabilities.

• Excellent verbal and written communication abilities.

• High degree of accuracy and attention to detail.

• Proficiency in Microsoft Office and web-based software applications.

• Capability to manage multiple priorities while working autonomously in a remote environment.

• Prior experience in supporting clinical research or healthcare operations is preferred.

• Familiarity with ICH-GCP guidelines and FDA regulations is preferred.

• Experience with Electronic Data Capture (EDC), CTMS, or eTMF systems is preferred.

• Understanding of clinical trial documentation and research workflows is preferred.

🏝️ Benefits

• Competitive salary

• Comprehensive medical, dental, and vision coverage

• 401(k) with employer contribution

• Paid time off and company holidays

• Remote work environment

• Professional development and career advancement opportunities