Address: Missouri City, TX *****

Phone: 832-***-****

Email: adjmyb@r.postjobfree.com

Abir Sinno

PROFESSIONAL SUMMARY

Ambitious, dedicated, hard worker researcher and pharmacist with more than 9 years of experience in research, clinical trials, and Institutional Review Boards (IRB’s). Highly experienced in the international ethical guidelines and regulations in clinical research, and the conduct of phase II, III, IV clinical trials. Very strong research and medical knowledge. Established the Standard Operating Procedures (SOP’s) of a Clinical Research Unit and worked closely with the IRB president on developing the IRB SOP’s.

WORK HISTORY

01/2015-01/2020

Institutional Review Board (IRB) Member, Secretary-General, Rafik Hariri University Hospital (RHUH-IRB is registered in the FDA as a foreign IRB and has a FWA number)

Managing IRB meetings, communicating IRB decisions to investigators and sponsors.

Preparing and updating IRB SOP’s in collaboration with the IRB president.

Representative speaker of the IRB in national meetings.

IRB Member reviewer of students’ research proposals and investigators-initiated studies

Pharmacist and research consultant voting member during IRB meetings serving the board with my research and pharmacy expertise.

Communicating and explaining IRB rules and regulations to hospital investigators.

Solving all queries of sponsors and investigators related to IRB SOP’s. 03/2011 – 01/02020

Clinical Research Coordinator (multiple roles), Rafik Hariri University Hospital

(RHUH), Clinical Research Unit (CRU), Lebanon

Quality assurance coordinator: creating and implementing the Clinical Research Unit SOP’s. Ensuring studies are carried out according to study protocol, FDA regulations, ICH Good Clinical Practice (GCP), local government regulations, and hospital regulations. GCP training of new staff. Solving and implementing corrective and preventative action plans under the supervision of the head of the unit.

Research assistant in investigator-initiated studies: Assisting in protocol writing. Developing informed consent forms, case report forms and source documentation forms. Speaker in Investigator meetings, trainer about case report forms (CRF) completion and GCP.

Pharmacist of the Clinical Research Unit: ensuring proper Investigational Products storage according to Good Storage Practices, stock and inventory control, IP accountability, handling, dispensing IP, performing patient’s visits and counseling patients.

Research Coordinator: Acting as intermediary and liaison between hospital, investigators, and clinical research organizations (CRO’s) and/or sponsors.

Assisting in monitoring visits, audit visits, site qualification visits, site initiation visits, close out visits.

SKILLS

• Project management

• Data management:

EDC Medidata Rave

InForm Oracle RDC

BioClinica Dacima

ePRO SPSS SAS

• Advanced power point

presentation skills

• Advanced written and oral

communication skills

• Quality control and Quality

assurance

• Research Ethics standards

• Clinical trials

• Public health

• Epidemiology

• Drug expert

EDUCATION

• MPH Epidemiology,

University of Texas Medical

Branch at Galveston

(4.0 GPA) – 2021

• MS Epidemiology,

American University of

Beirut (AUB) – 2019

• B.S. Pharmacy, Lebanese

American University (LAU)

– 2007

• French and Lebanese

Baccalaureate (with honor),

Carmel Saint Joseph School

PROJECTS

• Novartis trials:

CRAD001, Phase III, oncology

Steadfast, Phase IV

interventional, endocrinology

Transition, Phase IV

interventional, cardiology

LCZ compassionate use

program, Phase IV, cardiology

• Roche studies:

ARAMA, Phase IV, rheumatology

PegBase, Phase IV,

gastroenterology/infectious disease

• Janssen trials:

Galaxy, Phase II, gastroenterology

• Pfizer trials:

B3281006, Phase III, oncology

B7981007, Phase II,

gastroenterology (ICON CRO)

• Ipsen trials:

Adiase, Phase IV, gastroenterology

• Boehringer Trials:

Gloria AF, Phase IV, cardiology

BI 1275, Phase III, endocrinology

• Astellas trials:

WSA-CS-008, Phase III,

Infectious Diseases

• Shire trials:

MADCAM, Phase III,

gastroenterology

• Merck Studies:

DYSIS, Phase IV, cardiology

• Novo-Nordisk trials:

NN2211, Phase IV, endocrinology

• Sanofi-Aventis Trials:

VTE safety zone, Phase IV,

cardiology

CABAZ-C, Phase IV, oncology

• IQIVIA CRO Trials:

TAO, Phase III study, cardiology

• Parexel CRO trials:

ATPCI, Phase III, cardiology

• PPD CRO trials:

10TASQ10, Phase II, oncology

• Clintec CRO trials:

LUX-Breast, phase III, oncology

Identifying subjects, screening, reviewing inclusion and exclusion criteria, and randomization of study subjects. Additionally, performing any duty related to a pharmacist in the study. Informing the subject of all pertinent aspects of the study and assisting in obtaining informed consent. Instructing each subject on the correct use of the Investigational Product. Monitoring and following up with study participants on study requirements. Ensuring safety and well-being of study subjects are being protected.

Collecting/Reporting data on paper and electronic Case Report Forms. Resolving queries in databases.

Identifying staffing needs based upon study protocol and helping the principal investigator in staff recruitment and training. Budget development under the supervision of the principal investigator.

Responsible for preparing and submitting all regulatory documents to IRB, local government, sponsor and/or CRO’s. Preparing all IRB submission letters, SAE’s, progress reports, protocol deviation/violation, study renewal, study closure.

Handling laboratory kits ordering and shipping. Main experience with COVANCE labs.

Handling Investigator Site File (ISF). Handling safety events reporting within timelines.

Experienced in Phase IB, II, III, IV clinical trials and epidemiological studies. 02/2008 – 01/2011

Hospital and Oncology Pharmacist, RHUH, Lebanon

Compounding and dispensing medications, chemotherapy, and other preparations.

Reviewing medical orders for potential errors, interactions and/or wrong dosage.

Supervising drug preparation and dispensing performed by the pharmacy technicians’ staff, including compounding, packaging, and labeling of drugs.

Performing floor stock inspections of all hospital wards. Control stock level.

Training of new pharmacy personnel and students.

Providing drug information to physicians, interns, and nurses and contributing to the awareness of physicians in prescribing medications. 06/2007 – 02/2008

Full Time Pharmacist in community pharmacies, Lebanon

Pharmacist in charge. Dispensing medications, counseling, purchasing, inventory control, handling third parties, handling narcotics, administering vaccines. 02/2008 – 01/2019

Part time Pharmacist in community pharmacies, Lebanon

Dispensing medications, counseling, handling narcotics, administering vaccines.

Co-manager in a co-owned pharmacy for 2 years: pharmacy management, employees’ supervision and training.

05/2015 – 07/2015

Pharmacist Consultant, World Health Organization

Taking projects with the World Health Organization as a pharmacist contractor.

Worked on developing a WHO formulary manual based on the national list of chronic essential medicines.

01/2011-03/2011

Hospital Pharmacist, Saudi Aramco, Saudi Arabia

Outpatient and inpatient hospital pharmacist.

LANGUAGES

• English

• French

• Arabic

INTERNSHIPS

9/2020-12/2020

Research intern, Texas Department of State Health Services, USA

Worked on an electronic integrative tool (an original spiritual assessment template) for Clinical Chaplains to be integrated in the Electronic Medical Records (IRIS program) for the Interdisciplinary Teams (IDT) within the Austin State Supported Living Centers system (SSLC). Austin SSLC serves individuals with Intellectual/Developmental Disabilities (IDD). 01/2006-06/2007

Community pharmacy clerkships, Lebanon

Hospital pharmacy clerkships: Trad’s hospital pharmacy, Saint George’s hospital pharmacy, Makassed’s General Hospital, Lebanon

ICU rotation, CCU rotation, Pediatrics rotation, IM rotation, OBS rotation Pharmacy clerkship at Drug Information Center, Lebanese Order of Pharmacists. CONFERENCES

Launching of the Lebanon Clinical Trials Registry, Ministry of Public Health, Lebanon, 2019

MOH and CCNLE national workshop on research ethics, Lebanon, 2019

Janssen Investigator Meeting, Vienna, 2018

Novartis Investigator Meeting, Dubai, 2016

Lebanese Society of Medical Oncologists) workshop with Clinserv CRO, Lebanon, 2015

Novartis Investigator Meeting, Lebanon, 2015

Novartis Investigator Meeting, Jordan, 2014

Parexel Investigator Meeting, Turkey, 2014

Novartis Investigator Meeting, Dubai, 2013

GCP training with Novartis, Lebanon, 2012

GCP training with Boehringer Ingelheim, Egypt, 2012

Boehringer Ingelheim Investigator Meeting, Brussels, 2012

Novartis Investigator Meeting, Spain, 2012

Merck Serono Investigator Meeting, Lebanon, 2011

Astellas Investigator Meeting, Greece, 2011

PROFESSIONAL PRESENTATIONS

Speaker at: The National workshop in Lebanon on “Ethics of research involving human subjects and biosamples” held by the Ministry of Public Health (MOH) and the Lebanese National Consultative Committee on Ethics (CCNLE) in collaboration with WHO, UNESCO and USEK to share the RHUH-IRB experience and expertise, Lebanon, 2019

Speaker at: the LSMO (Lebanese Society of Medical Oncologists) PANARAB conference: workshop with Clinserv CRO about the” Role of a CRU in the prevention of fraud and misconduct in clinical research”, Lebanon, 2015

Speaker at: the Novartis Investigator Meeting about CRF completion and overview on GCP, Lebanon, 2015

Speaker at: the Novartis Investigator Meeting about CRF completion and overview on GCP, Jordan, 2014

CERTIFICATIONS

• Foreign Pharmacy

Graduate Equivalency

Certification in the US

(FPGEC)

• GCP certificate from

Boehringer Ingelheim,

Novartis, IQVIA

• CITI training for IRB

members and

administrators

• CITI Good Clinical

Practice Course for

Clinical Trials Involving

Drugs and Biologics

• CITI training on

Responsible Conduct of

Research

• COVID-19 Contact

Tracing training offered

by Johns Hopkins

University

• License to practice

pharmacy in Lebanon

• Member of the order of

Lebanese Pharmacists

• Worldwide Clinical Trials

BERIPLEX, Phase III, vascular

……surgery

• Other trials:

COLCOT study,Phase III, cardiology,

(Montreal heart institute)

• Investigator initiated:

Heart failure program study

MENA-HF study (sponsored by

Novartis)

Contact this candidate