Senior Clinical Research Coordinator

Main Duties And Responsibilities Ensure proper coordination with the Documentation and Logistics Team for the data entry and review of study source documents. Coordinate clinical studies and ensure their proper conduct in accordance with approved protocols, applicable local and international regulations, and relevant guidelines. Review clinical study documentation and evaluate Clinical Research Coordinator (CRC) performance. Provide training and orientation for clinical staff. Evaluate the Clinical Information Management System and coordinate with the Documentation and Logistics Team to identify and implement improvements. Collaborate with the CRC Supervisor and Site Supervisor to ensure the safety and protection of study subjects. Coordinate with the Purchasing Department to ensure the availability of all materials and equipment required by study protocols before study initiation. Ensure the preparation and review of clinical staff schedules. Supervise clinical study activities, including screening, admission, dosing, and follow-up, to ensure compliance with approved study protocols. Follow up on obtaining JFDA approval for study subjects, as applicable. Review the status and contents of essential documents required for clinical study conduct. Evaluate study deviations, ensure accurate and timely reporting, and collaborate with investigators to notify regulatory authorities, sponsors, and/or Institutional Review Boards (IRBs), as applicable. Attend JFDA inspections conducted during clinical studies and respond to inspectors' inquiries. Ensure the accurate, complete, and timely submission of study data to Quality Control (QC) and Quality Assurance (QA). Follow up on QA audit findings and ensure their timely resolution and closure. Prepare daily, weekly, and monthly reports related to clinical operations and study progress. Prepare weekly clinical schedules and monitor their implementation. Conduct in-process and final reviews of study files and prepare corresponding summary reports. Update and review Standard Operating Procedures (SOPs) and related forms. Follow up on the implementation of training procedures and the maintenance of training records for all clinical staff. Monitor and track CRC Key Performance Indicators (KPIs) in accordance with approved schedules and agreed timelines. Perform regular facility inspections to ensure compliance with applicable requirements. Identify and explore potential solutions to operational problems and share recommendations for process improvement. Perform any other duties assigned by the direct manager. Job Requirements Bachelor's degree in Life Sciences, Pharmacy, or a related field. Minimum of 4–6 years of relevant work experience. Positive attitude, professionalism, and a proactive approach to work. Good knowledge of Good Clinical Practice (GCP), international guidelines, and applicable regulations. Proficiency in both Arabic and English, written and spoken. Strong managerial, organizational, and leadership skills. Ability to interact effectively with individuals of diverse personalities and collaborate with cross-functional teams. Excellent communication skills, flexibility, and dependability. Ability to respond promptly and effectively to emergency situations while maintaining sound judgment. Good computer skills and proficiency in relevant software applications. Show more Show less