Jessica Bartlett
Peoria,AZ
Summary
Seasoned clinical research professional with a proven track record in training, quality assurance, and regulatory compliance. Demonstrates strong problem-solving skills and adaptability, driving operational efficiency and patient outcomes through innovative practices. Recognized for fostering team success and implementing effective processes that ensure audit-ready compliance. Aiming to leverage expertise in a challenging role to further enhance research quality and patient care.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Process Training Coordinator
IQVIA
10.2023 - 01.2025
- Designed and implemented interactive training programs, improving onboarding efficiency.
- Identified and addressed training gaps, enhancing compliance, and staff performance.
- Collaborated with leadership to develop long-term training strategies aligned with operational goals.
- Delivered in-person and virtual training sessions.
Senior Quality Assurance Specialist
IQVIA
03.2023 - 10.2023
- Conducted internal audits, ensuring 100% compliance with GCP and regulatory standards.
- Educated site staff on regulatory requirements, improving audit readiness across sites.
- Developed and implemented CAPAs to address and prevent recurring issues.
- Reviewed and verified essential documents, including source data, informed consent forms, and regulatory files.
Site Development Specialist/Clinical Study Manager
Elligo Health Research
04.2021 - 05.2022
- Established new research sites, reducing activation time through streamlined processes.
- Coordinated study startup, maintenance, and closeout for multiple clinical trials.
- Conducted IRB submissions and ensured timely reporting to regulatory bodies.
- Supported investigator training and onboarding, fostering effective site operations.
Vaccine Team Lead/Quality Training Specialist
Elligo Health Research
07.2019 - 04.2021
- Provided leadership and guidance to team members, ensuring that tasks were completed on time and to a high standard.
- Designed and managed onboarding and training programs for new hires, including curriculum design, mentorship, and progress tracking.
- Delivered virtual and on-site training.
- Identified training gaps and collaborated with senior leadership to develop solutions, increasing compliance rates across teams.
- Oversaw clinical SOP lifecycle management, ensuring updates, training compliance, and alignment with regulatory requirements.
- Conducted comprehensive clinical data collection, including patient interviews, adverse event monitoring, and compliance assessments for study medication regimens.
- Coordinated study startup, maintenance, and closeout for multiple clinical trials.
- Prepared and managed regulatory submissions, IRB submissions, and reporting to maintain compliance and ethical standards.
Lead Research Coordinator/In-house Monitor
Elligo Health Research
08.2012 - 07.2019
- Conducted internal audits of source documents, case report forms, and regulatory files to ensure compliance with GCP and regulatory standards.
- Developed corrective action plans and monitored completion by staff to address audit findings.
- Managed performance evaluations, provided coaching and counseling, and facilitated staff development and training.
- Coordinated all phases of clinical studies (startup, maintenance, and closeout) while collaborating with investigators and research teams.
- Completed regulatory submissions and maintenance.
- Completed IRB submissions and reporting.
- Conducted systematic data collection, including patient interviews, adverse event monitoring, laboratory reviews, and medication compliance assessments.
- Led the development and implementation of Standard Operating Procedures (SOPs) to streamline processes and enhance quality.
- Trained and mentored new study coordinators, ensuring competency in pharmaceutical research coordination.
Education
GED -
Rio Salado Community College
08-2007
Medical Assistant
The Bryman School of Phoenix
08-2004
Skills
- Leadership
- Strong organizational and time-management skills
- Exceptional communication and interpersonal skills
- Detail-oriented and able to handle multiple tasks simultaneously
- Quality Assurance & Compliance oversight, monitoring, & reporting
- Deviation management
- Knowledge of multiple EHR, EDC, IWRS, and CTMS systems
Certification
- Association of Clinical Research Professionals - CCRC
- CITI - GCP for Clinical Trials with Investigational Drugs and Biologics, Human Subjects Research, Conflict of Interest, OSHA Bloodborne Pathogens, PPE, Researchers, Shipping and Transporting of Regulated Biological Materials
Timeline
Senior Process Training Coordinator
IQVIA
10.2023 - 01.2025
Senior Quality Assurance Specialist
IQVIA
03.2023 - 10.2023
Site Development Specialist/Clinical Study Manager
Elligo Health Research
04.2021 - 05.2022
Vaccine Team Lead/Quality Training Specialist
Elligo Health Research
07.2019 - 04.2021
Lead Research Coordinator/In-house Monitor
Elligo Health Research
08.2012 - 07.2019
- Association of Clinical Research Professionals - CCRC
- CITI - GCP for Clinical Trials with Investigational Drugs and Biologics, Human Subjects Research, Conflict of Interest, OSHA Bloodborne Pathogens, PPE, Researchers, Shipping and Transporting of Regulated Biological Materials
GED -
Rio Salado Community College
Medical Assistant
The Bryman School of Phoenix
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