Overview
Work History
Education
Licensure
Timeline
Generic

RACHEL COVACIU

Valparaiso,IN

Overview

8
8
years of professional experience

Work History

Regulatory Affairs Manager

The University of Chicago
07.2023 - Current
  • Prioritize project-related tasks to efficiently complete essential tasks.
  • Manage the preparation, submission, and tracking of regulatory documents, including INDs, CTAs, and protocol amendments, ensuring accuracy and timely submission.
  • Collaborate with cross-functional teams, including clinical operations, quality assurance, and medical affairs, to ensure cohesive regulatory processes and successful clinical trial approvals.
  • Provide regulatory guidance to clinical teams on study design, protocol development, and risk mitigation strategies for global clinical trials.
  • Implement best practices in regulatory affairs and streamlined processes to improve efficiency and regulatory outcomes.

Clinical Research Coordinator II

University of Chicago-Neurology
05.2022 - 07.2023
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Conducted clinical trials and arranged patient visits according to protocol.
  • Collected data on research progress, adverse reactions, deviations, and results.
  • Performed QA/QC procedures, worksheets and study materials, and ordered supplies.
  • Ensured regulatory and subject compliance.
  • Helped create and implement improved ICF procedures.
  • Maintained information on protocol and case reports for each trial and identified subject eligibility.
  • Prepared consent amendments and processed specimens.
  • Prepared sponsor files for FDA compliance and GCP guidelines.
  • Maintained trial policy records and procedure materials.

Research Coordinator

University of Chicago-IPPH
12.2021 - 04.2022
  • Conducted clinical trials and arranged patient visits according to protocol.
  • Collected data on research progress, adverse reactions, deviations, and results.
  • Ensured regulatory and subject compliance.
  • Helped create and implement improved ICF procedures.
  • Maintained information on protocol and case reports for each trial, developed flow sheets and identified subject eligibility.
  • Prepared consent amendments and processed specimens.
  • Prepared sponsor files for FDA compliance and GCP guidelines.
  • Maintained financial uploads and weekly reports.
  • Maintained trial policy records and procedure materials.

Research Assistant

University of Chicago-IPPH
08.2021 - 12.2021
  • Participated actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities.
  • Organized research materials, maintaining a well-ordered workspace conducive to productivity.
  • Assisted with participation recruitment, scheduling, and obtaining informed consent.
  • Adhered to study protocols attentively and report deviations, AEs, and SAEs.
  • Collected biometric data and biospecimens; process specimens for shipping.

Emergency Room Technician

Methodist Hospitals Northlake
08.2019 - 07.2020
  • Responded quickly and calmly to emergency situations, providing life-saving measures when necessary.
  • Performed and measured the patient's vital signs, properly recorded and reported them to physicians and nurses; documented care provided and the patient's status as directed by the nurse.
  • Improved patient care by efficiently performing emergency room procedures such as wound dressing, splinting, phlebotomy, and CPR.
  • Trained new employees and performed stocking of supplies and ordering


Phlebotomist

St. Mary Medical Center
10.2016 - 04.2019
  • Enhanced patient experience through compassionate care and communication during blood draw procedures.
  • Collected blood and urine specimens using venous and micro techniques for med techs to analyze the results
  • Verified specimen collection information in laboratory information system
  • Communicated with patients and staff to provide information regarding status of orders
  • Followed established policies and procedures that aim to ensure sterile and accurate techniques are consistently utilized to provide the best results for patient and providers
  • Performed sterile procedures, i.e blood patches and was one of two trainers in the hospital on the procedure
  • Performed central processing tasks and prepared specimens to be sent out
  • Trained new employees on hospital software and improving techniques for efficient workflow


Education

Doctorate of Pharmacy -

Midwestern University
Downers Grove, IL
05-2027

Master of Science - Biomedical Sciences

Marian University
Indianapolis, IN
05-2021

Bachelor of Science - Human Biology

Indiana University
Bloomington, IN
05-2016

Licensure

05/2024 to Current                  Pharmacy Technician, IL                    049.312239

10/2016 to Current                  Phlebotomy Technician                     S8X4F8B9

Timeline

Regulatory Affairs Manager

The University of Chicago
07.2023 - Current

Clinical Research Coordinator II

University of Chicago-Neurology
05.2022 - 07.2023

Research Coordinator

University of Chicago-IPPH
12.2021 - 04.2022

Research Assistant

University of Chicago-IPPH
08.2021 - 12.2021

Emergency Room Technician

Methodist Hospitals Northlake
08.2019 - 07.2020

Phlebotomist

St. Mary Medical Center
10.2016 - 04.2019

Doctorate of Pharmacy -

Midwestern University

Master of Science - Biomedical Sciences

Marian University

Bachelor of Science - Human Biology

Indiana University

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RACHEL COVACIU