Hannah Anderson

Portland,OR

Summary

Clinical Research Associate with 5 years of sponsor-side field CRA experience managing Phase I–IV clinical trials across multiple therapeutic areas, including oncology devices and cardiovascular. Experienced in overseeing up to 15 sites through onsite and remote monitoring, ensuring compliance with ICH-GCP standards, fulfilling regulatory requirements, and adherence to study protocols. Demonstrated ability to coordinate vendor access, maintaining audit readiness, and building strong relationships with investigators and cross-functional teams.

Overview

years of professional experience

Work History

Clinical Research Associate / CRA Mentor

AstraZeneca

06.2022 - Current

Manage up to 15 investigative sites across up to 4 concurrent protocols, including complex endpoint-driven and cardiovascular studies.
Conduct an average of 6–8 onsite monitoring days per month, in addition to remote monitoring and site management activities.
Perform Site Qualification, Initiation, Monitoring, and Close-Out Visits (SQV, SIV, IMV, COV) in alignment with ICH-GCP and sponsor SOPs.
Conduct risk-based monitoring and site quality assessments to proactively identify compliance risks and performance issues.
Identified and escalated protocol compliance deviations related to use of incorrect informed consent versions; collaborated with leadership to implement a CAPA, increased monitoring frequency, and strengthened Principal Investigator engagement to restore compliance and prevent recurrence.
Conducted CRA onboarding support and training sessions, including co-monitoring guidance, protocol education, and eTMF process training.
Maintain the goal of having sites Ready to Enroll within 2 weeks of their Site Initiation Visit.
Maintain audit-ready documentation and support internal audits and regulatory inspections, including preparation activities and documentation review.
Supported database lock activities, ensuring timely resolution of queries and reconciliation of outstanding items.
Oversee investigational product accountability processes, ensuring accurate tracking, documentation, and reconciliation.
Collaborate cross-functionally with Clinical Study Teams, vendors, and data management to support study timelines and data integrity.

Clinical Research Associate II

AbbVie (Contract)

11.2021 - 06.2022

Executed monitoring activities across immunology and gastrointestinal studies, including site evaluations, monitoring visits, and follow-up actions.
Performed risk-based monitoring using study metrics and KRIs to identify site-level risks and ensure data quality.
Re-trained site personnel on protocol requirements and GCP compliance as needed.
Coordinated communication between sponsor teams, vendors, and investigative sites to support study execution.
Maintained regulatory and essential documentation within Veeva Vault systems.

Site Monitor

Pharmaceutical Product Development (PPD)

08.2020 - 07.2021

Managed regulatory documentation and EDC oversight activities in accordance with sponsor monitoring plans.
Conducted site management calls to review KPIs, protocol compliance, and site performance metrics.
Reconciled 3,000+ protocol deviations within established timelines to support quarterly data lock activities.
Performed risk-based assessments evaluating PI oversight, subject safety, and data quality.

Data Specialist

Colorado Blood Cancer Institute / Sarah Cannon

Denver, CO

08.2019 - 08.2020

Supported data collection for early-phase CAR-T therapy clinical trials in hematologic malignancies.
Applied CTCAE v5.0 criteria to assess and document adverse event toxicity grades.
Assisted with patient recruitment, pre-screening, and enrollment documentation.
Maintained accurate clinical data entry using Medidata RAVE and EMR systems.

Education

Bachelor of Science - Public Health

University of Nevada Reno

05-2017

Skills

Medidata RAVE
Veeva Vault (VCV, VQV)
Clario
IRT/IWRS (Signant, Calyx, Medrio)
Power BI
Control Tower

Microsoft Office Suite (SharePoint, Excel, Word, Outlook, PowerPoint)
Site management
Pharmacovigilance
Electronic Data Capture
Patient Reported Outcomes
Electronic Source

Timeline