Thair

5/16/2020
Fairfax, VA

Position Desired

Healthcare, Allied Health, Clinical Research Specialist, Epidemiology
Anywhere in NY
Yes

Resume

Education
2018 Master of Public Health, George Washington University, Milken Institute School of Public
Health, Washington DC
2011 Educational Commission for Foreign Medical Graduates certified (ECFMG)
2005 Master of Science in Physiology, Baghdad University, College of Medicine
1997 M.B.Ch.B. Bachelor in Medicine and General Surgery, University of Al-Mustansiriyah, College of Medicine

Work Experience:
National Cancer Institute/National Institute of Health, Bethesda, MD
February 2020– Present
Title: Clinical Data Manager II ​​​​​​
• Worked in a diverse clinical research environment providing data management support for phases I, II and III clinical trials.
• Managed the delivery of high-quality data from project start-up and planning to project execution and project closeout on several projects.
• Independently performed project-specific quality control and quality assurance tasks on all projects responsible for as well as when requested.
• Identified project specific reports and assisted in the development of these reports.
• Abstracted data from source documents as needed, understood laboratory and diagnostic results to access and monitor toxicities, evaluated tumor responses, and managed patient and protocol information.
• Performed duties of abstraction from EMR (CRIS) and source documents and entry of study data into the clinical database(C3D)


University of Rochester Medical Center/Strong Memorial Hospital, Rochester, NY
June 2018-March 2019
Clinical Research Assistant
• Performed literature reviews and extracted information to support the study.
• Screened, recruited, enrolled eligible patients to the trial ensuring they meet the protocol criteria for exclusion/inclusion.
• Did the informed consents log and the enrollment log.
• Expertly provided education to subjects on the research protocols, ensuring the subject compliance with the research protocol.
• With minimal supervision, scheduled patient’s visits and followed-up with study subjects.
• Initiated and attended meetings with principle investigator and clinical research team in order to provide updates on the progress of the clinical trial, identify and provide support to areas needed, and help provide protocol start-up logistics.
• Documented and analyzed the collected clinical research data.
• Structured and updated the electronic database using the REDcap research database.
• Manage the delivery of high quality data from project start-up and planning to project execution and project closeout on several projects
• Independently perform project specific quality assurance tasks on all projects responsible for as well as requested
• Ensure consistency, accuracy, and adherence to federal regulations, Good Clinical Practice. Good Clinical Data Management Practices, as well SOPs and Working Instructions
• Manage patient protocol information and review protocol and incorporate protocol-specific guidelines into the review of clinical trial data on several projects simultaneously
• Contribute to the design of the database and forms, ensuring they meet requirements for the entry and reporting of clinical data of varying complexity
• Test clinical trial databases and data entry screens assuring compliance with protocol and institutional processes and procedures
• Process, track, validate data accurately and on time, in accordance with data processing and entry instructions
• Perform data abstraction and data entry on several different protocols into multiple clinical research databases
• Assisted with the maintenance of IRB documentation and met deadlines for submission.
• Prepare, review, and submit clinical data to monitoring agencies
• Corresponded with the PI and the clinical team and performed duties as assigned by the PI.
• Coordinated visits, assisted and organized tests and procedures for patients participating in the study.
• Worked with the research team to ensure smooth operation of the research.
• Ensured protocol and GCP compliance.
• Prepared the regulatory documents such as study protocol, Investigator brochures, informed consent forms.


National Heart, Lung & Blood Institute/National Institute of Health, Bethesda, MD
May 2018-July 2018
Clinical Research Associate​​
▪ Monitored NHLBI intramural and multi-institutional research protocols and ensured clinical trials are conducted in a timely manner.
▪ Assured adherence to Good Clinical Practices (GCP) and the Code of Federal Regulations (CFR).
▪ Ensured adherence to IRB and ethical requirements especially in the areas of approvals, patient safety, and protocol compliance.
▪ Ensured all Serious Adverse Events (SAEs) are documented and reported to the IRB, sponsor, and FDA in accordance with the protocol.
▪ Thoroughly checked the patient data in CRF (Case Report Form) for accuracy while ensuring the safety and confidentiality of subjects.


Mid Atlantic Urology Associates Greenbelt, Takoma Park, Rockville, MD
April 2015-June 2017
Clinical Assistant
▪ Provided clinical support to the Chair of Surgical Department at Washington Adventist Hospital by obtaining patient medical history, providing physical examination, establishing patient notes and follow up documentation using medical software (EPIC).
▪ Assisted with minor procedures such as Foleys catheter insertion and removal, sutures removal, and surgical dressing change.
▪ Assisted the clinic to transition from paper to electronic medical records by scribing patient notes to EPIC database.
▪ Helped in patient's notes documentation and follow-up of his post-operative patients.
▪ Perform data abstraction and data entry on several protocols into multiple clinical research databases




Liberty Language Services:​
November/2014-June/2015
Medical Interpreter and Patient Care Assistant:
▪ Translated medical instructions from health care providers from Arabic to English and vice versa for patients with limited English proficiency.
▪ Traveled between different inpatients and outpatient clinical settings to provide linguistic patient support.


Observership/Volunteering Experience:
October 2010- December 2019
ADAMS Compassionate Healthcare Network, Chantilly, VA
March 2019-Dwcember 2019
• Working as part of volunteer team of over 80 of medical professionals helping uninsured
• people in need and providing them with healthcare.
• Under the supervision of the attending ph...

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