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Gina Shenoda, BS, MBA
1306 Oak Circle 484-350-0116
Lansdale, PA 19446 Gina.Shenoda@gmail.com
Objective:
Seeking a position within the Clinical Research/Pharmaceutical field.
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Education:
Delaware Valley College
Doylestown, PA
BS Biology
MBA
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Professional Skills:
• Proficient in Microsoft office Word, Excel, PowerPoint
• Project facilitator
• Heavily concentrated detail oriented research skill
• Effective time management/planning and organizational skills

Computer skills include: Word, Excel, Outlook, and PowerPoint, EDC.

Languages: Fluent English, Fluent Arabic.

Training includes:
• HIPAA Compliance Plan Training
• Query Training
• SAE Reporting Session
• ISO 9001:2000 Review
• Protocol and IDB Overview
• Code of Federal Regulations Overview
• GCP/ICH Guidelines Training
• Outlook Management
• Business Writing & Grammar
• Professional Behavior
• Drug Development Overview
• Introduction to Pharma and CRO Industry
• Abbreviations and Glossary Review
• Introduction to Clinical Research Data Management Overview
• Effective Communication Skills
• SOP Development and Management
• Site activity and CRF Review
• Study File Maintenance
• Drug Accountability Monitoring Experience
• Site Monitoring Visit ( PSV/ Initiation/SMV/Close out)
• Project Initiation
• Site selection
• Ethics/FDA regulations and IRB regulatory submission.
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Activities/Volunteer Experience:
Warminster Hospital, Warminster, PA September 2001-2002
Volunteer Lab Technician
 • Conducted visitations of patients.
• Recorded medical histories in charts.
• Provided patient education.
• Responsible for inventory.

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Experience:
Luitpold Pharmaceuticals, Inc., Valley Forge, PA
Clinical Research Associate

Managing Clinical Trials sites Duties include:

• Development of study related documents: Drafting FDA Form 1572
• Patient Informed Consent Form Review
• IRB Approvals/Submissions.
• Freedom of Information searches (FOIs)
• Prepare materials for investigator meetings and CRU training meetings to ensure study consistency.
• Develop methods and track reporting of adverse events, protocol deviations, and patient status.
• Coordinates the interactions/follow-up with sites, assigned vendors or co-development partners.
• Communicate findings to CMP in a timely manner.
• Assure that adequate study and regulatory documentation is properly maintained, filed and archived.
• Assist with data analysis to ensure protocol compliance, understanding and data validity.
• Work with all relevant departments to assure the successful completion of a trial.
• Set-up, populate and maintain the clinical trial monitoring/management tracking systems.
• Available to travel and Monitor (75%) upon request.
• Responsible for PSV/SIV/SMV/Close-out/Drug Accountability Monitoring in accordance with GCP Guidelines and
regulatory requirements
• Manages investigative sites, including selection, initiation, routine monitoring and closeout visits and regular
communication to: collect accurate and complete clinical data, verify source documents, collect study documents
and ensure compliance with the study protocol and ICH/GCP Guidelines and regulatory requirements.
• Site management, communication and follow up ( Confirmation faxes, Monitoring reports, follow up letters)

• Therapeutics/Study Experience:

- Anemia & Chronic Kidney Disease

ICON Clinical Research, North Wales, PA April 2007- Present

Clinical Research Associate I
Managing Clinical Trials sites Duties include:
• Development of study related documents: Drafting FDA Form 1572
• Patient Informed Consent Form Review
• IRB Approvals/Submissions.
• Freedom of Information searches (FOIs)
• Prepare materials for investigator meetings and CRU training meetings to ensure study consistency.
• Develop methods and track reporting of adverse events, protocol deviations, and patient status.
• Coordinates the interactions/follow-up with sites, assigned vendors or co-development partners.
• Communicate findings to CMP in a timely manner.
• Assure that adequate study and regulatory documentation is properly maintained, filed and archived.
• Assist with data analysis to ensure protocol compliance, understanding and data validity.
• Work with all relevant departments to assure the successful completion of a trial.
• Set-up, populate and maintain the clinical trial monitoring/management tracking systems.
• Available to travel and Monitor (75%) upon request.
• Responsible for PSV/SIV/SMV/Close-out/Drug Accountability Monitoring in accordance with GCP Guidelines and
regulatory requirements
• Manages investigative sites, including selection, initiation, routine monitoring and closeout visits and regular
communication to: collect accurate and complete clinical data, verify source documents, collect study documents
and ensure compliance with the study protocol and ICH/GCP Guidelines and regulatory requirements.
 • Site management, communication and follow up ( Confirmation faxes, Monitoring reports, follow up letters)

• Therapeutics/Study Experience:

1. Oncology: Malignant Brain Tumor. Phase III

2. Chronic Constipation/Irritable Bowel Syndrome: Phase III
3. Down Syndrome: Phase III
4. Kawasaki Disease: Phase III
5. Flu Vaccines: Phase II, III
6. Women’s Health: Contraception, Phase III

Tri-County Eye Physicians & Surgeons, Southampton, PA August 2006 -April 2006
Ophthalmic Technician

• Participated in minor surgeries, induced, monitored, and maintained and recovered patients from local anesthesia
(cataract surgery). Provided ophthalmic assistance to doctors, including record keeping of all patient-doctor
information and interactions in the exam room. Managed visual field ancillary exams. Worked closely with the
Glaucoma specialist and tested patients for various diseases including Glaucoma and retinal disorders. Calculated
fluid rates and administered drops/medications for various surgical support functions. Took topographical pictures of
cornea, optic nerves, and macular discs. Managed and trained ophthalmic technicians.

Primary Eye Care Associates January 2002-August 2006

Ophthalmic Technician/Assistant Manager

• Executed technical and clinical functions as required by the study protocol and according to Standard Operating
Procedures. Maintained security of patient records, data, and equipment. Entered, maintained, and tracked data in
the computer database. Ensured confidentiality of study protocols and that subject was maintained. Participated in
sponsor visits and audits. Interacted with all patients. Collaborated with management to resolve technical/study
concerns and problems.