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Lead Clinical Research Regulatory Administrator Data Manager Resume Example

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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Professional Summary

Experienced Regulatory Administrator with a demonstrated history of working in the hospital & health care industry. Skilled in Electronic Data Capture (EDC), Oncology, Pulmonary, Good Clinical Practice (GCP), Regulatory Documentation, and Clinical Research. Strong clinical research professional with a Master of Science degree focused in Clinical Research and Product Development from University of North Carolina, Wilmington.

Education
Masters of Science: Clinical Research and Product Development, Expected in 2018
to
University of North Carolina - Wilmington, NC
GPA:
  • Graduated with 3.9 GPA
Bachelor of Science: Public Health, Expected in 2010
to
Andrews University - Berrien Springs, MI
GPA:
Certifications

Certified Clinical Research Professional (CCRP), SoCRA

Rave EDC Essentials for Clinical Research Coordinators

Certified Nursing Assistant (CNA)

Therapeutic Areas

Oncology Phase II & III Clinical Trials {Adult, Pediatric}

Pulmonary Phase II, III, & IV Clinical Trials {Adult}

Work History
Lead Clinical Research Regulatory Administrator/Data Manager, 01/2018 to Present
Davita Conyers, GA,
  • Ensures that all necessary IRB reports are submitted on a timely basis.
  • Maintains tracking of all documents submitted to the IRB to ensure that they appear on the agenda and are acknowledged by the IRB with a letter.
  • Assists the Research Manager in developing and maintaining databases, spreadsheets and other tools for reporting activities.
  • Prepares regulatory documents for initiation of new research studies and maintained them in a complete, comprehensive, and efficient manner.
  • Performs regular audits and maintenance of all Regulatory documents for trials that are open with the IRB or in the follow-up phase.
  • Demonstrates an understanding of FDA Regulations, Good Clinical Practice Guidelines, and ICH Guidelines.
  • Responsible for meeting with Monitors during visit and resolving issues that arise from the Monitoring visits.
  • Ensures that the Regulatory Binders are maintained and up to date throughout the course of the study.
  • Assists in completing Close-out visits of all completed studies.
  • Responsible for IRB submission of protocol amendments, amendment training for site, maintaining and updating training logs, and notifying site of consenting requirements Acts as a liaison for Novant Health Clinical Research with the trial sponsors and maintains continuous communication and efficient coordination of all activities involved in initiating new studies and maintaining regulatory documents for all studies.
  • Continually reviews data submission status and assists staff with completion of projects and queries.
  • Assures completion of correct case report forms and timely data submission.
  • Develops processes related to specific needs of the successful conduct of cancer clinical research.
  • Makes follow-up phone calls to patients as needed, consent patients as directed, and electronically build study related flow sheets to be used as source documents for research coordinators.
Clinical Research Coordinator/Data Manager, 06/2018 to 01/2018
Crozer-Keystone Health System Glen Mills, PA,
  • Performed data entry by submitting data collected at study visits into various sponsor specific data capture systems (EDC) Reviewed medical records obtained from study patients and updated site database.
  • Reviewed data for obvious data corrections and assisted with query resolution.
  • Scanned documents into Electronic Medical Record system for clinic.
  • Performed data entry by submitting data collected at study visits into various sponsor specific data capture systems (EDC) Reviewed medical records obtained from study patients and updated site database.
  • Reviewed data for obvious data corrections and assisted with query resolution.
  • Scanned documents into Electronic Medical Record system for clinic.
Dialysis Patient Care Technician, 12/2018 to 11/2018
Fresenius Medical Care City, STATE,
  • Accountable for outstanding customer service to all external and internal customers, resolving issues with all customers in a timely manner.
  • Developed and maintained relationships through effective and timely communication.
  • Initiated dialysis treatment according to prescribed orders including blood flow (QB) and dialysate flow (QD).
  • Responsible for calculating and entry of individual patients' dialysis machine programming for Ultrafiltration (UF) goal; treatment time; Sodium (Na) modeling; and UF modeling as prescribed.
  • Performed and recorded Pre and Post dialysis evaluation, weight and vital signs with initial identification.
  • Conducted all tasks necessary for preparation for dialysis treatment and documented where appropriate.
  • Reviewed treatment sheets for completeness, ensuring nursing signatures were documented, and ensured omitted entries were completed or corrected where appropriate.
Regulatory Affairs Coordinator, 01/2018 to 08/2018
Stryker Medical City, STATE,
  • Reviewed customer complaints and entered technical report information into database for further investigation.
  • Partnered with cross-functional teams and the Quality Assurance Investigator group to achieve organization metric requirements.
  • Ensured timely, accurate, and complete failure investigations projects of product complaints leading to root cause analyses and corrective/preventive action.
  • Performed detailed audits on technical reports written by service technicians to ensure documents met Regulatory and FDA standards.
  • Conducted the tracking of regulatory documentation utilizing relevant tools as appropriate.
  • Ensured timely closure of complaints to comply with FDA requirements.
Skills

Oracle, InForm Electronic Data Capture (EDC), and Medidata Rave. Microsoft Office Suite including Outlook and PowerPoint. Windows XP and Mac OSX.

IBM AS400, PTC NetRegulus, and J.D. Edwards EnterpriseOne Solution Explorer.

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Resume Overview

School Attended
  • University of North Carolina
  • Andrews University
Job Titles Held:
  • Lead Clinical Research Regulatory Administrator/Data Manager
  • Clinical Research Coordinator/Data Manager
  • Dialysis Patient Care Technician
  • Regulatory Affairs Coordinator
Degrees
  • Masters of Science
  • Bachelor of Science

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