Data Entry Clinical Research

April C. Diaz

Curriculum Vitae

Office Address: Children’s Hospital of Michigan;

Department of Pediatrics

**** ******** *********, *******, **

48201

Email: *************@*****.***

Personal Mobile: 313-***-****

Educational Training

2019-2020 Wayne State University – Mike Ilitch School of Business, Master of Business Administration

2012-2013 University of Nebraska Medical Center, Post-Baccalaureate Degree, Cytotechnology

2008-2012 University of Nebraska – Omaha, Bachelor of Science, Biology Minor Chemistry

Experience Oct 2016 - Present Wayne State University – SOM Lead Research Assistant – Sickle Cell Research Pediatrics

Manages Regulatory Documents: IRB Initial Submission, Continuations, Amendments, and Safety Reporting

Manages Source documentation including data entry, tracking case report forms and resolving queries, and reconciling between source documents and EDC systems (i.e. Oracle Health Sciences InForm, Medidata Rave, and Perceptive MyTrials)

Coordinates participant recruitment, obtains consent forms from parent and participant, ensures participant retention, and conducts study visits

Liaison for Principal Investigator and study sponsors for study start-up (contracts and budgets) and protocol quality assurance

Manages Daily Operations of the office: staff training, staff oversight, budgeting, inventory, and project planning

Apr 2016-Oct 2016

Somnos Clinical Research

Clinical Research Coordinator- Respiratory Clinical Trials

Screened potential participants for Respiratory Clinical Trials

Conducted participant study visits including PFTs, spirometry analysis, 6-minute walk test, and data entry with EDC systems (i.e. Oracle Health Sciences InForm and Medidata Rave)

Managed IRB Submissions working with a Central IRB

Managed Regulatory Documents

Jul 2015-Sep 2015 Kessler Plastic

Surgery

Plastic Sales Coordinator

Informed patients on practice products, Invasive and Non-invasive procedures, and surgeon background

Coordinated pre-operative and post-operative tasks including consents, patient lab screening, and implant inventory

Organized in-office events to promote sales or introduce new products Dec 2014- May 2015 Nebraska Medicine

Medical Scribe

Accurately dictated patient encounters, including but not limited to patient history, physical exams, diagnostic findings, and lab test results on behalf of Emergency Physicians

Assisted with patient care under the supervision of an Emergency Physicians

Spearheaded the first Medical Scribe program at Nebraska Medicine Aug 2008 – Aug 2012 University of Nebraska Medical Center/Omaha VA Medical Center Orthopedic Research Assistant

Managed daily operations including laboratory inventory and animal care

(Sprague Dawley Rats)

Managed data collection, analysis, and presentations

Worked closely with PI, Sub-I, fellows, and residents in completion of protocol procedures

Trained new research team including pre-med students and residents Publications

2013 Poster Presentation: Cytotechnology Alumni Views On Virtual Microscopy In Cytotechnology Education (Maheswari Mukherjee, PhD, MS, CT (ASCP), Amber D. Donnelly, PhD, MPH, SCT (ASCP), April C. Diaz, BS, Stanley J. Radio, MD)

Titanium implant with nanostructured zirconia surface promotes maturation of peri- implant bone in osseointegration. Dusad A, Chakkalakal DA, Namavar F, Haider H, Hanisch B, Duryee MJ, Diaz A, Rensch A, Zhang Y, Hess R, Thiele GM, Fehringer EV. Proc Inst Mech Eng H. 2013 May; 227(5): 620-22.

Awards

• 2013 Best Sage Paper Award

Skills & Certificates

• 4 years’ experience as a Regulatory and Study Coordinator in Therapeutic Clinical Research: Hematology, Oncology, Sickle Cell Disease, & Respiratory

• Trained in multiple different Electronic Data Capture (EDC) systems: Oracle Health Sciences InForm, Medidata Rave, and Perceptive MyTrials

• Trained in EMR Systems: EPIC and Citrix (CIS)

• CITI Certificate in ICH GCP Compliance

• I.A.T.A Certification

• CITI Certificate in Human Subjects Research

• Ability to Travel 75% of the month and live 30 min away from a major international airport

• Proficient in Microsoft Office Suite: Word, Power Point, Outlook, & Excel

• Strong Communication skills; both verbal and written

• Stellar time management and social skills

References

Available upon request

Contact this candidate