Clinical Research Specialist
Hikma Pharmaceuticals
Total years of experience :8 years, 6 Months
Support the Institutional Official in obtaining initial accreditation and re-accreditation of the Association for the Accreditation of Human Research Protection Programs, Inc. (AHHRPP).
Develop and communicate policies and procedures for the program activities according to regulatory requirements and ethical conduct of research principles.
Conduct routine and for cause reviews/audits to assure compliance with the program policies and procedures.
Develop and implement educational plans for HRPP staff, IRB members and KHCC investigators.
Develop and coordinate public outreach activities plans and materials.
Collect, analyze and report program performance data, regularly.
Conduct surveys to evaluate effectiveness of various aspects of the program, and identify improvements
to program policies, procedures and guidelines.
Act as liaison between program supporting entities and provide regulatory and procedural guidance.
Receive and respond to questions, concerns and complaints regarding the program.
Plan and coordinate the initiation of research protocols.
Write and submit grant applications and IRB applications.
Conduct literature reviews related to different aspects of cancer care.
Develop case report forms, surveys, informed consents and other project related documents.
Translate documents, informed consents and surveys from English to Arabic.
Coordinate the collection and analysis of project data.
Monitor the progress of project activities and budget according to the project action plan.
Communicate regularly with project team at different sites to ensure information flow and adherence to goals, policies, budgets and timelines.
Prepare periodic and ad hoc reports and presentations as required by project managers, funding agencies, and/or regulatory bodies.
Implement quality control process throughout the conduct of the project.
Participate in the development of informational brochures and booklets, strategic frameworks and article manuscripts.
Manage the day-to-day operations of the IRB Office including IRB review process of research proposals and meetings.
Assist in the developing, drafting, recommending, and implementing policies and procedures to enhance efficiency of committee operations and general office functions.
Participate in the review of research proposals and KHCC BioBank documents and forms.
Provide guidance to internal and external investigators and research team regarding procedural requirements for submission to the IRB, review type, documents required for submission and key
principles related to research ethics.
Act as liaison between IRB chairperson, IRB members, investigators, clinical research coordinators and
national authorities regulating clinical research in Jordan.
Participate in training and orientation tasks of new committee members.
Organize research ethics workshops and other educational activities.
Work collaboratively with the IRB Chair to facilitate ongoing development, implementation and
maintenance of the human subject’s protection program.
Graduated with Distinction. Awarded the Vice-Chancellor’s Scholarship. Dissertation entitled “Anticoagulants Safety in Clinical Practice”, 2015. A 2-year retrospective study of near-miss events and medication errors related to anticoagulant therapy at Addenbrooke's Hospital located in Cambridge, England.