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.
