Summary
Overview
Work History
Education
Skills
Certification
Timeline
Generic

Jenessa Rodriguez

Bakersfield,CA

Summary

Regulatory specialist with a strong background in clinical trial management, regulatory compliance, and GCP standards. Offering 3+ years of experience in protocol adherence and site management. Committed to contributing to high-quality clinical research and expanding knowledge in the field.

Overview

4
4
years of professional experience
1
1
Certification

Work History

Clinical Research Assistant

Kern Research, Inc.
Bakersfield, CA
12.2021 - Current
  • Ensured efficient maintenance and filing of the site file binder for both paper documents and the e-regulatory system, such as Complion, for various studies.
  • Facilitated a smooth study startup by managing the preparation of sponsor-related documentation. (e.g., organizing site file binders, implementing training for new studies, ensuring all required documents are completed and returned to sponsors such as FDF, 1572, protocol signature page, etc.)
  • Collaborated with the study sponsor and site staff for the Close Out Visit, ensuring all necessary documents were completed and returned to the study team.
  • Ensured seamless and efficient information flow between all parties involved in the trial by effectively communicating with investigators, study staff, sponsors, vendors, IRB personnel, etc.
  • Ensured proper temperature control across different areas including ambient, refrigerator, and freezer.
  • Developed study visit materials (sources, AE logs, etc.). In compliance with protocol guidelines to ensure alignment with research objectives, and regulatory standards.
  • Maintained inventory of supplies used in clinical setting.

Unblinded Pharmacist

Kern Research, Inc.
Bakersfield, CA
12.2021 - Current
  • Receiving and confirming the arrival of Investigational Product (IP) shipments at the site in the IRT system.
  • Ensuring proper disposal and return of used, unused, or expired (IP) kits, in line with Standard Operations Process (SOP).
  • Maintained and updated (IP) accountability records in the pharmacy binder.
  • Collaborated with uCRA to ensure quality assurance in pharmacy binder
  • Demonstrated expertise in administering site injections while upholding the blinding of study medication to subjects and other personnel.

PG/ Ambassador/ Pick Associate

Amazon Fulfilment Center
Bakersfield
09.2020 - 03.2021
  • PG roles include overseeing ambassador staff and ensuring they’re properly training their new hires
  • Created Schedules for employees, training new hires, handled new hires onboarding
  • Training associates on proper use of equipment and trained on proper use of PPE.

Education

Bachelor of Science - Kinesiology (Allied-Health Concentration)

Cal State University, Bakersfield
Bakersfield
05-2024

Bakersfield College
01.2022

Taft College
01-2022

Menlo College
12-2019

Skills

  • Administering subcutaneous injections
  • Medicinal Terminology Knowledge
  • Detailed Orientated
  • Proficient in Excel
  • Maintaining Quality Assurance
  • Professionalism
  • Problem-solving aptitude

Certification

  • CPR/AED Certified
  • GCP Compliance

Timeline

Clinical Research Assistant

Kern Research, Inc.
12.2021 - Current

Unblinded Pharmacist

Kern Research, Inc.
12.2021 - Current

PG/ Ambassador/ Pick Associate

Amazon Fulfilment Center
09.2020 - 03.2021

Bachelor of Science - Kinesiology (Allied-Health Concentration)

Cal State University, Bakersfield

Bakersfield College

Taft College

Menlo College

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Jenessa Rodriguez