Rania Riad

*** ******** **. ****** **

909-***-****

Email: adzjsp@r.postjobfree.com

Personal Summary:

Hardworking, well mannered, friendly with a positive attitude to work. Able to uphold high standards of service and speed while adhering to regulations and procedures. Experience of working in fast paced facilities, completing tasks in a timely manner with ability to work independently or as a team, a quick learner who can easily obtain the goal.

Work History:

•Senior Lead Clinical Research Studies Coordinator

ObjectiveHealth Clinical Research 02/2023-Present

•Clinical Research Quality Assurance/ Regulatory Specialist

CenExel Centers of Excellence Clinical Research 01/2021-02/2023

•Volunteer first responder fire fighter rescuer/EMT

Speedway Fire Department 2020 Present

•Volunteer English ESL/ TOEFL Teacher at POLY language Institute, and the leader of weekly book meeting and discussion 2019-2020

•Clinical Research Site Director, Sub Investigator, and Senior Lead Project Manager

Rawan Institutes, Egypt 03/2013-09/2019

•Clinical Laboratory scientist

Prof. Hanan S. laboratories professor of Immunology and Microbiology in Tanta Faculty of Medicine, Egypt 1/2009-12/2013

•Clinical pharmacy Manager

The Egyptian Ministry of Health Governmental Ophthalmology and Dentistry Hospital 06/2006-09/2019

Experience:

•Clinical Research Quality Assurance, Control/Data Management and Regulatory Experience:

*Participated in 70+ clinical studies phase I-IV for:

Gilead Sciences Inc., Vertex Pharmaceuticals Incorporated, Teikoku Pharma USA, Inc., Pfizer, Mylan Pharmaceuticals Inc., Intra-Cellular Therapies, Inc., Eli Lilly and Company, Eisai Inc., Eccogene Inc., Bristol-Myer Squibb Co., AbbVie, Inc., ACADIA PHARMACEUTICALS, INC, AMGEN, INC., BIOGEN, CALI PHARMACEUTICALS, CELGENE INTERNATIONAL, JANSSEN, BRAINTREE, NOVAVAX, UPSHER-SMITH LABS. with 100+ training Certificates and Licenses.

*checking the source, complex payments processing, invoices, expenses, quarterly payments, cost tracking spreadsheets, sending notifications, resolving queries, reviewing informed consents, IRB submission and continuing reviewing, Vendors forms and communications, assisting in CAPA checking DOA, roasters, checking charts, eligibility inclusion exclusion criteria, preparing for monitors visits, Complete CRFs/Data query Resolution/Reviewing EDC transcription (e.g, Data Management and regulatory Activities), HCP reporting, supervise devices Calibration and maintenance, inspect for appropriate disposal for medical devices, Quality Documentation and batch record review, and Training new hires.

*Demonstrated knowledge of GCP/ICH guidelines, FDA regulations, GMPs, GLPs, IQ/OQ/PQ with Complete proficiency using Quality Management systems, CTMS, Clinical and medical affairs contractual costs using current processing systems, TMF platforms, Shared Investigator Platform, FIRECREST, iMedidata, Clinical Conductor, Real-time clinical management systems, UltiPro, Paylocity, MedPace, Protocol First, Florence, Labcorp, drugDevSpark, Viedoc, Oracle Inform, Exostar, Veeva Vault, box, CRIO, Complion, Smartsense, Intergy, EHR, Longboat and Impala.

• Senior Lead Clinical Research Coordinator/Quality Assurance Experience:

*Worked on 150+ Phase I-IV Interventional Trials and Observational studies for treatment, prevention, Screening, Cohort, Case control, Cross sectional, Multi-arm Multi-Stage (MAMS), Pilot and feasibility for Oncology, Biomarkers, Hepatology, CNS, Gastroenterology, Hematology, Hormone Replacement, Cardiology, Ophthalmology, Endocrinology, Dermatology, Genetics, Genomics, Mental Health, and auditory conditions.

*Preparation of research budgets, contact vendors, communicating with patients, investigators and laboratories, coordination between departments and organizations.

* Quality Control/Assurance, Regulatory, and Data management activities

*Consenting and interviewing subjects, taking vital signs & Electrocardiogram, recording adverse reactions, analyzing problems and assist in resolutions.

* Work with the PI to develop and implement recruitment strategies in accordance with HRPO (IRB) requirements and coordinate appropriate and timely payments to participants.

*Cooperate with the sponsor compliance and monitoring efforts related to subjects’ protection HIPPA and reports instances of noncompliance to the appropriate compliance office.

* Assist the PI in development of materials and tools necessary for training according to protocol requirements, schedule of visits, execution of research plan and maintain documentation of training

*Coordinate with Principal Investigator to help ensure that clinical research and related activities are performed in accordance with regulations, policies and procedures.

* Collaborate with PI and institution to respond to any audit findings and implement approved recommendations.

* Assist Investigators to assure that all persons engaged in the research project have met training requirements.

*Labeling, storage and shipment of samples.

•Clinical laboratory scientist Experience:

-Valid License for Biosafety, Biosecurity, Shipping and transport of Regulated Biological Materials-

* Performing high complexity testing in hematology, chemistry, blood bank, microbiology, molecular cell biology and Fluorescence in Situ Hybridization, ELISA

Immunological investigation, coagulation profile evaluation, blood smear, fertility assessment, hormonal assay, PCR, urine, blood and sputum cultures and synovial, plural, ascitic fluids, allergy testing, DNA sequencing, fragment testing and blood transfusion investigations, screening of Down Syndrome, Flowcytometry and electrophoresis.

* Analyzing the chemical constituents of the patient's body fluids

* Testing blood for drug levels to determine the effectiveness of treatments.

* Determining blood-clotting abnormalities

* Cross-matching donor blood for transfusions

* Evaluating test results for accuracy and interpreting them for the physician

* Operating sophisticated lab equipment such as cell counters and microscopes

* Storing and retrieving equipment and chemicals according to the manufacturer's specifications

* Logging data from medical tests and entering results into a patient's medical record

* Discussing the results and findings of lab tests and procedures with physicians

•Pharmacy Manager Experience:

*Building professional relationships with patients, and healthcare providers.

*Communicating with physicians and nurses to reconciliate patient's medications, educating patients and coordinating their compliance.

*Dispensing prescription medication and counseling patients

*Training the pharmacy staff and mentoring them

*Managing the inventory, ensuring safe storage for prescription drugs and controlled substances.

*Educate healthcare providers colleagues and communicate with them to ensure patients safety

* Perform Administrative Tasks like keeping patient files up to date, making sure needed products are stocked and required reports get generated and filed.

* Deal with Insurance companies to ensure payment and resolve coverage denials.

Skills:

•Phlebotomy, ECG, Vital signs, patient monitoring and first aid experience.

• Superior attention to minor details, great analytical and problem shooting and solving skills.

• Excellent knowledge of medical, clinical, healthcare, pharmaceutical terminology.

•Highly focused on providing patients with experience in medical records.

•Bilingual fluency (Reading, writing and conversation) English, French being a graduate of Notre Dame Des Apôtres school, Arabic, and some Spanish.

• Complete proficiency using Quality Management systems, CTMS, EDC, Veeva Vault, Clinical and medical affairs contractual costs using current processing systems, TMF platforms, Shared Investigator Platform, FIRECREST, iMedidata, Clinical Conductor, Real-time clinical management systems, UltiPro, Paylocity, CRIO, Complion, Protocol First, MedPace, Florence, Intergy, Labcorp, drugDevSpark, Viedoc, Inform, Exostar, box, Longboat and Impala.

•Demonstrated computer skills and data entry (IT certificate)

•Excellent Written, Verbal communication skills including body language.

•Multitasking abilities for projects while maintaining SOPs with superior attention to details in a timeline environment.

•Demonstrated ability to compound and dispense medications and pharmaceutical supplies.

•Comprehensive understanding of chemicals used in different concentrations, adverse effects and drug interactions.

Education:

Bachelor’s degree (Clinical Pharmacy Sciences)

***CERTIFICATES and LISENCES (All are available upon request):

*Board Pharmacy Equivalency 2014

*TOEFL certificate Advanced level reading, writing, listening and speaking

*First aid and CPR

*GCP for Clinical Trials with Investigational Drugs and Biologics

*Biomedical Research, Human Subject Protection

*Information Privacy Security IPS

*Emergency First Aid

*Basic Life Support CPR and AED

*Personal Protective Equipment

*IATA Transportation of Dangerous Goods

*License of Biosafety, Biosecurity, Shipping and Transport of Regulated Biological Materials

*Mental Health for Higher Ed and Healthcare

*Understanding and Addressing Mental health Campus: Opportunities and Challenges in Higher Education

*Veeva Valut CDMS for Clinical Research Coordinators

*Data Integrity And Source Documentation

*SOP-CR-009.01 Rating Scales

*Medidata MEDS Reporter: Rave Modules, Rave EDC, Rave EDC(SMIT), and MEDS Reporter

* Medidata Rave Reporter: Rave Modules, Rave EDC, Rave EDC(SMIT), and MEDS Reporter

*Medidata Classic Rave EDC Essentials

*Veeva Valut CDMS What’s New in 22R1

*Veeva Valut CDMS What’s New in 22R3

*Bloodborne Pathogens for First Responders

*Blood borne Pathogens for Public Entities *Spinal Motion Restriction

*Abdominal Aortic Aneurysm

*Abdominal Trauma

*12-Lead EKG

*Airborne and Bloodborne Pathogens

*Absorbents and Spills

*Eating Right for Health and Fitness

*Human Subjects Research

*Good Clinical Practice - Clinical Staff (GCP)

*Information Privacy & Security - Clinical Staff (IPS)

*Responsible Conduct of Research *Conflict of Interest

*OSHA Bloodborne Pathogens

* COVID-19: Back to Campus

*COVID-19: Insights for Higher Ed Leaders

*Participating in Vaccine Research

*Remote Contact Tracing

*What You Need to Know About COVID-19 Vaccine

*Top Noncompliance Risks and Mitigation Strategies

*Guide to Being a Sponsor-Investigator

*Accreditation 101 for New and Adjunct Faculty

*Artificial Intelligence (AI) and Human Subject Protections

*Blockchain and Higher Education *Bring Your Own Device (BYOD) Studies

*Building a ClinicalTrials.gov Compliance Program – Tips for Investigators and Institutions

*ClinicalTrials.gov Enforcement

*Cost Allowability on Federally Sponsored Awards

*COVID-19 and Human Research Protection Programs

*COVID-19: Supporting Ethical Care and Responding to Workforce Concerns in a Public Health Emergency

*CRISPR Genome Editing: Rewriting DNA and the Future of Humanity

*Data Management and Security for Student Researchers

*Decentralized Clinical Trials (DCTs) and Your Workforce

*Ethics & Policy Issues in CRISPR Gene Editing

*Export Compliance: An Overview for Staff, Students, and Faculty

*Facial Recognition Considerations for Researchers

*FCPA and University Research: What Faculty and Administrators Need to Know

*FERPA and Online Learning in the Time of COVID-19

*Review of the Law for Researchers and IRBs

*GDPR & Human Subject Research in the U.S.

*Gender and Sexual Minorities (GSM) in Human Subjects Research

*Getting Started in Grant Writing: An Introduction for Graduate Students, Postdocs, and New Faculty

*Health Disparities: Promoting Equity and Diversity in Clinical Research

*Higher Education Accelerated Credit

*How to Effectively Manage a Research Administration Team

*Importance of Peer Review and Data Validation in Research

* Improving the Clinical Trial Participant’s Experience: From

*Informed Consent and Clinical Investigations: A Focus on the Process

*Recruitment through Study Closure

* Informed Consent and Research with Wearable Tech

*Intellectual Property and Working with Your Technology

Transfer Office

*IRB Administrator Professional Development and Self- Advocacy

*International Students in Focus at U.S. Higher Education Institutions (HEIs)

*IRB Protocol Noncompliance: When Research Goes Rogue, What Next?

*IRB Review of Observational Research

*Leveraging IT Insight in IRB Review: Why Technology- Based Expertise is Critical to Human Subjects

*Managing Conflict with Your Dissertation Chair

*Managing Your Grants as Systems: A Guide for Grant Management Success

*Medical Marijuana: A Budding Field of Research

* Noncompliance and the IACUC: Basic Approaches for Success

*Nuts & Bolts of Running a Virtual IRB Meeting

*Open Access Publishing

*Partnering with Technology Companies

*Preparing to Publish in Traditional and Hybrid Journals

*Principles and Practices for Managing Undue Foreign Influence in an Academic Environment

*Privacy and Ethical Considerations for Connected and Automated Vehicles

*Race in Clinical Research: Ethics and IRB Decision Making

*Remote Informed Consent: The Same, but Different, but Still the Same

*Research Equity and the Part We Play

*Research in Wound Care

*Research with Audio-Visual Mobile Data Collection Tools: Ethics and Regulations

*Research with Native American Communities: Important Considerations When Applying Federal Regulation

*Revised Common Rule: Overview of Revisions

*Revised Common Rule: Revisions to Definitions

*Revised Common Rule: Revisions to Informed Consent

*Running a Virtual IRB Meeting

*Social Media and Research Recruiting

*The Challenge of Medicare Advantage Plans and Local Coverage Determinations

*The Playbook: Successfully Developing and Deploying Digital Clinical Measures

*Title IX and the New Regulations

*Transitioning Research to the Revised Common Rule: The

What, How, and Why

*U.S. Department of Defense (DoD) Regulations & Requirements for Human Subject Research

*Understanding 483s and Surviving Them

*Understanding and Addressing Mental Health on Campus: Opportunities and Challenges in Higher Education

*Understanding Consent Requirements and “Key Information” Under the Revised Rule

*Understanding Decentralized Clinical Trials (DCTs) and Virtual Study Visits

*Working with Your IRB

*Regulatory Document Maintenance *Record Retention

*Electronic Regulatory

*Regulatory Document Maintenance

*Subject Withdrawal, Early Term, and Lost to Follow-up

*Study Participant Safety and Adverse Events

*Obtaining Informed Consent

*Pandemic Procedures

*Vendor Selection

*Software System Validation

*Disaster Recovery

*Protected Health Information

* Standard Operating Procedures

*Handling Liquid Nitrogen

*Temperature Monitoring

*Administrative Changes to 01Jan2022 Standard Operating Procedures and Working Practices

*Regulatory Document Maintenance *Handling Medical Emergencies

*Study Participants Expressing Suicidality *Management of Investigational Product *Communicating with Colleagues

*Workplace Bullying

*Conflict Resolution in the Workplace *Ethics in the Workplace

*Promoting a Drug-Free Workplace

*Celebrating Diversity

*The Respectful Workplace: Stop Harassment in Its Tracks

*Sexual Harassment

*Know Your Rights - California Harassment Protections

*Crash Cart Maintenance

*Handling of Controlled Substances

*FDA Audits and Inspections

*Equipment Calibration *Information Technology

*Waste Management

*Facility Security

*Fraud and Misconduct

*Good Documentation Practices

* Documenting Deviations

*Study Participant Recruitment

*Sponsor Monitor Visits

*Remote Study Participant Visits

*Clinical Conductor Data Standardization

*Study Participant Admission, Confinement, and Discharge

*Escalation Process

*Quality Control/Quality Assurance

*Study Procedures

*Transfer of Charts and Regulatory Documents

*WP-LB-001.02 Laboratory Safety and Maintenance

*Blood Collection Process

*Blood Specimen Handling

*PBMC Processing

*Pharmacy and Drug Room Cleaning

*Clinical Trial Activities

*Handling Infectious Materials

*Maintaining the LAFW, CAI, and BSC

*Numerous Firecrest, LongBoat, iMediData, Veeva Valut, Videoc certificates for Various phases of Studies.

*Pathology, Anatomy, Histology, physiology, Immunology, Microbiology, Biology, Zoology, geneticists and marketing Studies.

*Numerous Training and Course certificates for Clinical Studies for: Pfizer, Vertex Pharmaceuticals.

Affiliations:

Devoted numerous hours volunteering at non-profit organizations for humanity, homeless food banks, animal rescue, student education, nursing during disasters, current volunteer first responder, EMT/fire fighter.

Links:

https://www.linkedin.com/in/rania-riad-277b08226

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