Meselu Amare

Alexandria, VA ***** • 727-***-**** • ad2edb@r.postjobfree.com

Professional Summary

Determined and team oriented research professional with 10+ years of experience. Skilled in project management, data analysis, and achieving desired results. Adaptable to any situation and skilled in effective communication and interpersonal relations. Highly organized ad thorough with good planning and problem-solving abilities. Ready to help team achieve company goals.

Skills

Electronic Data Capture Tools: Clinical Data Manager, REDCap, Oracle, Medidata RAVE, INFORMS, mARVIN

Therapeutic Area: Oncology (Specialized in GYN, GI, GU and Melanoma/Sarcoma)

Computer Skills: MS Office Package, Epic, Athena Health, Sovera, Sunrise XA, GE Centricity, Mosaiq Citrix.

Department of Defense(DoD) and Department of Vetrans affairs(VA) EHR systems, including AHLTA, TDMS, JLV, HIMS and DVEIVER.

Applicable Guidelines (FDA, GCP, ICH, and HIPAA, Regulatory)

Monitoring Visits

Adverse Event Documentation

Work History

Clinical Research Coordinator II, 08/2019 to Current

Henry M Jackson Foundation – Bethesda, MD

Collected data and followed research protocols, operations manuals, and case report form requirements.

Developed and maintained accurate and up-to-date case report forms and source documents.

Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.

Exercised leadership capabilities by successfully motivating and inspiring others.

Actively engage in training new staff members and undertake responsibility of creating and maintaining training materials, both for internal use and for benefit of participating sites.

Clinical Research Data Manager, 08/2015 to 07/2019

Peraton – Reston, VA

Assisted leaders and program management in coordinating and producing reports for special projects.

Identified issues, analyzed information, and provided solutions to problems.

Gained extensive knowledge in data entry, analysis, and reporting.

Performed self-audits and peer reviews when requested for regulatory compliance and verification of complete and accurate data abstraction based on medical and clinical understanding and judgment.

Managed patient privacy and security regulations including but not limited to HIPAA and HITECH ACT.

Clinical Research Data Manager, 08/2008 to 07/2015

MD Anderson Cancer Center At Orlando Health – Orlando, FL

Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets.

Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.

Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.

Followed informed consent processes and maintained records including screening and enrollment logs, drug accountability logs, subject identification logs, site signature logs.

Gained extensive knowledge in data entry, analysis, and reporting.

Collected data and followed research protocols, operations manuals, and case report form requirements.

Education

Bachelor of Science: Health Information Management, 06/2007

University of Central Florida - Orlando, FL

Associate of Arts: Associate in Art And Science, 05/2005

St. Petersburg College - Clearwater, FL

Affiliations

SOCRA

Certifications

GCP

CPR

Professional Médical Interpréter(Amharic)

Languages

English

Amharic

Native or Bilingual

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