Samar Al-Saleh

• Undertake research and evaluation activities that provide government departments and local authorities with evidence
required for the formulation, implementation and evaluation of policies.
• Responsible for research department development.
• Serve as a subject matter expert by educating, consulting, and guiding researchers, faculty, staff, and students in the design and conduct of human subject research to ensure compliance with the country regulations and policy. Advise research personnel in preparing research protocols and subsequent submissions for REC review.
• Educate and guide REC members on the regional regulations and policies governing human subject research.
• Pre-review research protocol submissions to ensure that individual research protocols involving human subjects are in compliance with federal regulations, state laws and policies and procedures for conducting research. Independently conducts and document administrative and regulatory reviews within the context delegated by the REC chair.
• Compose letters that accurately communicate and document the determinations, describing any/all revisions required by the PI to secure REC approval.
• Develop and implement education sessions on topics related to human subjects’ research protections to Amana Healthcare’s researchers and REC members.
• Prepare REC meeting agendas and meeting materials for distribution to REC members. Assist the Assistant Director and REC Chair in facilitating the conduct of convened REC meetings. Prepare meeting minutes.
• Participate in the development, revision, and implementation of the research office policies and procedures, REC forms, website content, and other initiatives.
• Perform other related duties and participate in special projects as assigned.

• Responsible for the coordination and administration of clinical, develop, implement, coordinate research and administrative procedures for the successful management of clinical trials. Performing diverse administrative duties requiring analysis, sound judgment, and a high level of knowledge of study specific protocols.
• Carrying out data collection and using basic statistical tools in research to draw meaningful interpretation and reporting of the research findings .
• In collaboration with other statisticians and scientists, contribute to analyze data and statistics on living things collected during medical research studies to draw conclusions and execute research studies.
• Writing and implementing Standard Operating Procedure’s for the research department.
• Planning and Leading meeting affectively for research advisory committee members.
• Supervising clinical data collection and analyzing the data for research purposes.
• Sample Processing for clinical trials purposes by performing specimen processing, sample storage, and shipping the samples to the core laboratory as required by the protocol.

Participant in the design, implementation and monitoring of clinical trials, preparation of integrated medical reports, INDs, periodic reports, New Drug Applications (NDAs), etc. Participates in design and writing of protocols, case report forms and informed consent forms for clinical trials. Productive in recruitment/selection of new investigators, contract research organizations and outside vendors. Responsible for planning and implementing all activities required to conduct and monitor complex clinical trials and ensures that Good Clinical Practices (GCP) are followed. Conducts site visits pre- study, at study initiation, at regular intervals during the study and at study closeout. Monitors investigator performance and adherence to protocol, and proactively addresses conduct issues and
enrollment problems, auditing, source data verification and creating corrective action plans as necessary.
Ensures that Case Report Forms (CRF) are reviewed in a timely fashion and submitted to the data management group. Involved in the compilation/writing of integrated medical reports and clinical sections of INDs, New Drug Applications (NDAs) etc. Assists in preparation of presentations and manuscripts of scientific meetings and technical journals. Attends scientific/professional meetings and training courses as appropriate.

• Planning, overseeing and organizing medical research projects at Saudi Arabia’s first BioBank facility.
• Researching and souring viable research subjects. Conducting investigative interviews to collect necessary data. Ensuring consistent accuracy, confidentiality and diligence throughout.
• Representing the center in a public relations capacity, promoting its services and facilities.
• Offering analytical skills and quality control measures to ensure continued excellence across research projects.
• Creating and designing educational medical brochures for the center; providing information to people in an understandable and clear manner.
• Proof-reading, analyzing and editing medical research papers and published articles for medical journals
• Institutional Review Board (IRB) Coordinator: Secondary regulatory resource for investigators and staff for clinical and non-
clinical investigations as directed by the IRB Manager. This works in accordance with the processes and procedures that are established by IRB Leadership in accordance with ICH-GCP guidelines.
• Patient enrollment, Database management, Specimen collection, Data Collection, Source document completion and case report form filling (data retrieval)
• Attending meeting, taking minutes of meeting and submit reports that’s serves as an official record.

• Based on Phlebotomy and Hematology benches; receiving, processing and analyzing
• Conducting variety of laboratory test services including routinely or experimental processes
• Using, cleaning and maintaining various types of laboratory equipment
• Handling and storing chemicals and related materials
• Carrying out administrative tasks such as maintaining notebooks, documenting procedures,

Working as a volunteer based in Immunology Research laboratory. Providing assistance and acting as co-investigator on research paper