Clinical Research Coordinator

Main Duties And Responibilities Assure proper conduct of the study according to protocol and international regulations and guidelines. Providing training & orientation for study staff and ensuring that training and delegation records are filled properly. Cooperation with Principle/Clinical investigator to ensure the safety and protection of study subjects. Ensure that the subject’s health insurance policy covers the study period, and JFDA(Jordan Food and Drug Administration). study approval is available in the study Master File Before. Ensure that all materials/equipment required by study protocol are available before starting the study conduct. Collects data as required by the protocol. Assures timely completion of Case Report Forms. Perform any additional tasks attributed to it in order to develop the quality and output level of the department Ensure preparing and reviewing of study staff schedule and following up on their activities during the study. Supervising the nursing staff dedicated to conducting tests and collecting samples according to the study protocol. Monitor screening of study subjects, ensuring adherence to study inclusion/exclusion criteria. Monitor the procedure of ECG (Electrocardiogram), vital signs measurement, and all biological sample duties (harvesting,labelling, separation, packaging, storage, and transportation to the analytical department). Assures that amended informed consent forms are appropriately implemented and signed by all screened study subjects. Ensure that all necessary correspondences with the subject, part-time staff, restaurant, and contracted medical lab (if needed) are done. Ensuring that all study participants are enrolled on the JFDA database. Dosing the study subject under investigator supervision. Review study data-related excel sheet documents. Work on Clinical Information management system (Prestosoft) and print the required study forms Ensure obtaining volunteers’ informed consent before starting screening. Review Trial Master File During, source documents including CRF(Case Report Form) & ICF. (Informed Consent Form). Report deviation of the study protocol and collaborate with the investigator to inform regulatory, sponsor and/or IRB. Prepare a summary of the lab results not significant deviations report. Measuring height and weight of subjects, reporting smoking, alcohol intake and concurrent medication during screening. Completes study documentation and maintains study files in accordance with sponsor requirements on the agreed timeline. Attend JFDA inspection during the study and respond to their inquiries. Assure quality & timely submission of data to QC(Quality Control), QA (Quality Assurance), and DM( Data Management). Follow up and close out QA audit Prepare, check and review PRU platform related data. Job Requirements Bachelor &/or Master’s degree in Life Sciences or Pharmacy or a related field, or diploma degree in Life Sciences or Pharmacy or a related field with at 0-5 years working experience. Communicator with a positive attitude towards work. Good knowledge of GCP and international guidelines. Good command of Arabic and English languages both spoken and written. Managerial, organizational and leadership skills. Interact effectively with many different personalities and/or team members Good communications skills, flexible and dependable. Reacts fast in emergency situations while keeping clear vision. Computer knowledge. Show more Show less