Human Research Protection (HRPP) Monitor-King Fahad Specilalist Hospital-Dammam (Research Center) (ت

"• Conducts post IRB Approval Monitoring/Auditing visits for all ongoing research studies, visits the study departments to check on trials/research conducted, and their progress.

• Monitors compliance with HRP policies, IRB requirements and the regulations of NCBE and other regulatory bodies (e.g. Saudi FDA, MOH, US-FDA, OHRP, DHHS), and compliance with standards set by AAHRPP, GCP, JCIA, and CBAHI.
• Monitors patient safety, drug dosages given to patients, gathers all relevant information during an adverse event and monitors protocol deviation.
• Investigates allegations and findings of non-compliance. Recommends action to the IRB, based on observations during directed (for-cause) audits or audits requested by IRB. Reports potential serious or continuing non-compliance with applicable regulations or institutional policies to the IRB and/or organizational official.
• Observes the consent process for any ongoing study participants as per IRB request to verify subject comprehension and ensure all consent process elements are covered.
• Participates in the readiness process for AAHRPP accreditation.
• Mentors IRB members, investigators, research staff, and other members of research community through training, educational sessions, individual briefings and regional meetings. Communicate with local, regional, national and international research regulatory offices, provides input regarding local research policies.
• Contributes to developing and implementing HRPP quality improvement/assurance plan.
• Performs maintenance of electronic filing systems including shared folders and HRPA email account. Enters clinical trials and clinical research studies into the HRPA database.

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Qualification Requirement:

• Master”s Degree in Nursing, Pharmacy, Biology or related field. • Bachelor”s Degree in Nursing, Pharmacy, Biology or Medical degree (MBBS/MD) or related field.       • Registered with Saudi Commission for Health Specialties.

Experience Requirement:

• Two (2) years experience in related field or no years of experience for Saudis after Master's degree. • Two (2) years experience in related field or no years of experience for saudis after Bachelor.