Clinical Research Social Media

Yeme H. Arias

301-***-**** • Email: ******@****.***

Education: Daytona State College, Daytona Beach FL

Computer Science (In progress)

Clinical Research Management Inc., Coral FL

Clinical Research Associate (CRA)

Barry University, Miami, FL

Masters in Biomedical Research

Washington Hospital Center, Washington DC

Medical Technology (Internship)

Radford University/Virginia Polytechnic Institute and State University, Blacksburg, VA

Bachelor of Science, Biology/Chemistry Minors: Math/Psychology

Work Experience:

11/2019-Present Window to the Past LLC, Orange City, FL

Research and Social Media Coordinator

Gathered and organized research for a historical multimedia project

Set up social media accounts and prepared website pre-launch multimedia plan

06/2010-06/2013 Orlando Clinical Research Center, Orlando FL

Quality Assurance Coordinator

•Reviewed protocols, and informed consents of 100+ clinical research studies from phases 1 through 4

•Established and maintained communications with OCRC employees, health care providers, regulatory agencies and study sponsors

•Reviewed patient medical charts and lab reports for completeness and accuracy ensuring they were in compliance with good clinical practices

•Ensured the filing and maintenance of regulatory documents

•Reviewed serious and non-serious adverse effects and reported to Investigators

•Maintained and updated SOPs

•Ensured regulatory binder was updated and all essential documents were filed before monitoring visits

•Followed up with Query Resolution

•Assisted with the training of clinical research coordinators and research staff

•Developed control system to improve efficiency compliance and quality to ensure good clinical practices

11/2007-04/2008 Physicians Research Alliance, DeBary, FL

Lead Study Coordinator

•Traveled to multiple sites obtaining informed consents prior to screening, enrolling, and providin quality patient care in accordance with protocols and FDA, GCP/ICH guidelines

•Dispensed and retrieved study medications, accurately recorded data in source documents and CRFs, reported SAEs in timely fashion, and resolved queries

•Trained medical staff in order to increase productivity and improve time management

09/2006 - 11/2007 United BioSource, Kansas City, MO

Clinical Research Associate/Site Manager/Regulatory Document Specialist

•Monitored multiple sites from initiation to closeout in compliance with SOPs and FDA, GCP/ICH guidelines to track patient enrollment, retrieved and reviewed CRFs for consistency, accuracy and completeness, identified discrepancies and resolved queries, ensured that SAE reporting was documented and reported to sponsors and regulatory agencies

•Traveled to investigator meetings to train study personnel

•Participated in identification of potential investigators and clinical sites

08/2003-08/2004 Washington Hospital Center, Washington, D.C.

Medical Technologist Intern

•Performed clinical laboratory tests on body fluids including cells and tissues using ELISA, PCR, Western Blot, ABO cross-matching techniques in Chemistry, Hematology, Urine Analysis, Cell Culture, Molecular Biology, Microbiology, Toxicology, Coagulation and Immuno-hematology.

•Specimen Preparation techniques included making basic solutions, reagents and buffers for DNA/RNA Extractions, Protein Extractions, Stem Cell Isolations and Cell Culture.

•Calibrated and operated on Cell Dyne, Star, IL682, BNII, Vitek, Bactec 9000, Fluorescent Microscopy and Cobas PCR

04/2003-09/2003 Georgetown University Hospital, Washington D.C.

General Clinical Research Assistant

•Assisted Primary Investigators and CRCs in implementing laboratory safety and infection control procedures following Good Laboratory Practices (GPL) to ensure patient safety.

•Performed laboratory calculations such as dilutions and weights.

•Conducted clinical applications such as vital signs, ECG, lab specimen processing, phlebotomy and IV

•Performed basic lab maintenance tasks, set up medical record files, reviewed and updated SOPs and multiple protocols

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03/2000-05/2001 Georgetown University, Medical Center, Washington D.C.

Clinical Research Assistant II

Performed molecular and serological techniques for DNA isolation and amplification to ensure HLA histocompatibility for bone marrow transplants

Worked independently and demonstrated ability to multitask effectively and displayed flexibility in task completion.

Computer Skills:

Microsoft word, Excel, Power Point, Data Entry, Windows, MS Dos, Internet, Cerner, LCM, EPM, Right track I and II, Clin Rep Net, Eclipse, EEL, Elara, I Net, eIIP, iView,RDC, A-1 Computer Repair, Introduction to Programming, HTML5/CSS3

Continuing Ed:

Essential Documents; Safety Reporting Responsibilities; Confidentiality Matters; Potential Scientific Misconduct and Fraud; AEM Adverse Event Monitoring; AEM Report Form Completion; Safety Investigator Reports; Global Policy on Interactions with Health professionals ; Mater files Maintenance; Clinical Monitoring; Policy on Investigator Identification; Policy on Conducting Initiation, Interim and close out; Subject Directed Clinical Study Recruitment Materials; Investigator Initiation Package; Non Interventional Drug Studies; Regulatory Inspection; Breaking the Blind; ICH GCP Guidelines; Standard Operating Procedures; Safety Reporting Procedures; Drug Development Trials; Medical Terminology; Medical Ethics

Therapeutic areas:

Oncology, Cardiology, Asthma, Bronchitis, Obesity, Osteo-arthritis, Diabetes, Fibro-myalgia, Ulcerative colitis, Hypertension, HIV, Infectious disease. Phases I, II, III and IV studies

Professional Membership/Certification:

AAMC: Association of American Medical Colleges

IBPA: International Biopharmaceutical Association

NIH: Protecting Human Research Participants; Cancer Clinical Trial Basics; IRB Review

ASCP: Eligible

Phlebotomy and IV: Certified

CPR: Certified

Computer Skills: Microsoft Office 365, Cerner EMR, HTML, CSS, Computer Repair, Python Programming

Volunteer Activities: SCOAN Thessalonica, Greece. International Social Media Translator

Professional references will be furnished upon request.

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