A.H. Sawas, PHD

adr9u9@r.postjobfree.com **** Kilarney Ridge Loop, Cary, NC 27511

adr9u9@r.postjobfree.com Mobile 919-***-**** or 1-860-***-****

Accomplished researcher and educator with over 30 years of experience in pharmacology, toxicology, and higher education has been achieved. Decorated instructor with a solid track record of establishing new standards, programs, and best practices to improve overall quality of universities and educational institutions were established. Effective communicator with reputation for collaboration with professionals and students across countries, cultures, and languages. Areas of Expertise include:

Basic & Clinical Pharmacology Research

Toxicology

Regulatory Compliance

Clinical trial monitoring manager

Research Ethics

ISO System Consultancy

COVID-19 vaccine monitoring

Animal Testing

Environmental Issues

Quality Assurance

Curriculum Development

Staff Training & Leadership

Process Improvement

Principle Human Protection administrator 2021 – up

Meharry Medical College, TN:

· Assist in the development of new and revision of existing policies and procedures in support of Meharry’s IRB. Maintain current references on regulations and policies. File regulatory documents appropriately to maintain accurate and complete records of all IRB activities.

· Maintains a formal training program in protection of human subjects as required by the OHRP.

· Ensures clinical trial studies at Meharry (both industry-sponsored and university-sponsored), comply fully with FDA requirements.

· Work with the IRB Chair/Vice Chair and members to ensure that all research and research related items submitted to the IRB are reviewed and acted upon in a timely manner in accordance with IRB SOPs. Keeps abreast of regulations, practices and procedures that affect the protection of human subjects while working with the IRB Chair to ensure that IRB members remain knowledgeable on such matters.

· Serve as a resource for the human subjects’ protection program related to questions on preparing submissions and compliance with IRB Standard Operating Procedures (SOPs).

· Review submitted protocols and ensure compliance with federal regulations, coordinate expedited review of eligible submissions, screens protocols submitted to the IRB to determine whether they are Exempt or qualify for Expedited/Full Board review.

· Screen incoming applications to identify those that require additional reviews (IACUC, IBC, Radiation Safety, etc).

· Manage communications between the IRB, sponsors, PIs, and the IRB office; draft and distribute the IRB meeting agenda and protocol documents for review; draft and distribute IRB minutes in a timely manner per IRB SOPs; document the IRB’s determinations in letters and distribute to stakeholders.

· Maintain databases and spreadsheets for tracking studies and IRB submissions

· As accreditation programs from external IRBs and Human Protection Programs change, ensure the Meharry’s IRB and Human Subject Program are informed.

· Assist with additional tasks as needed.

Clinical Trial consultancy solution, NC, USA 2018 – 2020

MONITOR AND Consultant:

· Assigned site manager and monitor for COVID-19 vaccine.

· Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically

· Assists in the preparation and review of protocols, eCRFs, study manuals, and other study documents as requested by Clinical Trial Manager

· Works with the Study Start-up Group to coordinate activities with the site in preparation for the initiation of studies. Obtains and reviews regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents

· Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities

· Trains site staff on the EDC system and verifies site computer system

· Conducts periodic site file audits to ensure compliance with GCPs and Novella standard operating procedures

· Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner

· KING ABDULAZIZ MEDICAL CITY (NGHA- JCI accredited institute 2016) · Saudi Arabia · 2012 – 2017

IRB Research Scientist

· Review bioethics of research projects of NGHA in multiple regions including Riyadh, AlHasa, Jeddah, and Madinah to gain approval for clinical trial and quality research protocol proceedings

· Ensure compliance with ICH/GCP of documents, investigator skill level, and site preparedness by site monitoring for compliance.

· Examine exclusion/inclusion criteria and adverse effects as part of risk management efforts

· Protect patient safety with pharmaco-vigilance focused on personalized medicine approach and monitoring clinical trial protocol proceeding.

· Outline adverse effects with illustrations, case analysis, and inspection data to clarify any misconceptions. Analysis of adverse effects including serious adverse effects, investigating possible relation and ensuring patient ethical management.

· Deliver bioethics instruction to medical/pharmacy students, MSc bioethics program, and pharmacokinetic training of King Abdullah International Medical Research Center (KAIMRC)

· Collaborate with clinical research units and scientific researchers to promote ethical scientific research programs as well as compliance with ICH/GCP by conducting awareness educational training.

· Developed module to standardize IRB office review, monitoring adverse effects and overcoming variations.

· Preparation of monitoring report and clinical trial motion of approval for IRB board.

· Direct involvement in interventional clinical on MERS-CoVe management and narrow therapeutic drug clinical pharmacokinetics.

TAIBAH UNIVERSITY · Madinah, Saudi Arabia · 2010 – 2012

Instructor of Pharmacology & Toxicology – Faculty of Pharmacy

· Designed a critical thinking, case learning pharmacology/toxicology course for medical and pharmacy students that has been adapted for the pharmacology/toxicology track

· Performed researched focused on environmental health hazards and antioxidants’ role in health prevention

UMM AL-QURA UNIVERSITY · Makkah, Saudi Arabia · 2005 – 2010

Instructor of Pharmacology & Toxicology – Faculty of Medicine

· Instructed medical students in pharmacology and toxicology courses

· Performed research on drug abuse, quality assurance of laboratory drug screening, and clinical management of addition including clinical adjunction practice for drug addiction managements at Al-Amal hospital (Jeddah)

KING ABDUL AZIZ UNIVERSITY · Jeddah, Saudi Arabia · 2004 – 2005

instructor of Pharmacology & Toxicology – Faculty of Pharmacy

· Educated pharmacy students on pharmacology, toxicology, and biostatistics

· Applied ISO standards to manage quality assurance of the education and health aspect application

· Contributed to the establishment of an animal laboratory for student illustrative instruction

STATE UNIVERISTY OF NEW YORK · Stony Brook, NY · 2001 – 2004

Undergraduate Pharmacology Lab Director – Research associate of Pharmacology – Anesthesiology Department

· Led courses in pharmacology theory and animal testing practices

· Researched drug biological interaction by using isothermal titration calorimeter

· Developed novel essay on biological toxodynamic induced by oxidative stress

Education & Credentials

CRA – Wake Technical college 2020

Doctor of Philosophy, Pharmacology

HERIOT-WATT UNIVERSITY Edinburgh, UK

Bachelor of Science, Pharmacy

CAIRO UNIVERSITY Cairo, Egypt

CITI Training 2021

Multiple training course – Human Research subject protection, IRB, Biosafety, HIPPA, Bioethics and GCP

See: accompanied sheet for details.

UNESCO Ethics Teaching Training License, 2015

ICH/GCP License, 2012 – 2015

New Jersey Environmental Health Specialist License #395, 1999—Present

Environmental Health Specialist State Examination, Rutgers University, New Jersey, 1998

Professional Affiliations

PRIM & R membership

International Association of Ethical Education (IAEE)

New Jersey Environmental Health Association

New Jersey PHA

Free Oxygen Society USA

British Pharmacological Society

British Asthma Group

Egyptian Pharmaceutical Society

Asia bioethics genetic group- Shenzhen- China

Saudi Toxicological Group

MENA Oncology Society

Saudi Environmental Society

Honors

British Council Overseas Award

Abha Cultural Club – Best Book on Drug Abuse entitled of “Cocaine from Coca Cola to Dependence.”

Publications can be supplied upon request

CITI Training courses:

Completed Courses

Learner Tools

Meharry Medical College

Bioethics

Stage 1 - Basic Course

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 18-Dec-2021

Meharry Medical College

Biomedical Responsible Conduct of Research

Stage 1 - RCR

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses a

Passed 29-Jun-2021

Meharry Medical College

Biosafety Complete Training Series

Stage 1 - Biosafety/Biosecurity

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 25-Aug-2021

Meharry Medical College

Biosafety Retraining Course

Stage 1 - Biosafety/Biosecurity

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 16-Aug-2021

Meharry Medical College

Group 1.Social and Behavioral Research Investigators and Key Personnel.

Stage 1 - Basic Course

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 15-Sep-2021

Meharry Medical College

Group 1: Good Clinical Practice w/Investigational Drugs & Biologics (ICH Focus) Course

Stage 1 - Basic Course

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 13-Jul-2021

Meharry Medical College

Group 2.Biomedical Research Investigators and Key Personnel

Stage 1 - Basic Course

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 07-Sep-2021

Meharry Medical College

Institutional Biosafety Committee Member Course

Stage 1 - Biosafety/Biosecurity

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 18-Aug-2021

Meharry Medical College

Institutional Official: Animal Care and Use

Stage 1 - Animal Care and Use

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 05-Jul-2021

Meharry Medical College

Institutional/Signatory Official: Human Subject Research

Stage 1 - Basic Course

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 25-Jun-2021

Meharry Medical College

Introduction to Biosafety

Stage 1 - Biosafety/Biosecurity

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 09-Aug-2021

Meharry Medical College

IRB Administration

Stage 1 - Basic Course

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 02-Jul-2021

Meharry Medical College

IRB Chair

Stage 1

Passed 12-Oct-2021

Meharry Medical College

IRB Reference Resource

Stage 1 - Basic Course

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 09-Oct-2021

Meharry Medical College

NIH Recombinant DNA (rDNA) Guidelines

Stage 1 - Biosafety/Biosecurity

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 17-Aug-2021

Meharry Medical College

Training for Investigators, Staff and Students Handling Biohazards.

Stage 1 - Biosafety/Biosecurity

The Post-Course Survey includes evaluation questions about your satisfaction or dissatisfaction with the course, and about CITI Program products and services overall. Completion of this survey is entirely voluntary. Participation has no effect on your course completion. Responses are confidential.

Passed 16-Aug-2021

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