Jessica L. Packwood
Charlotte,NC
Summary
Accomplished Senior Clinical Research Associate with a proven track record of excelling in employee mentorship and client relationship management. Experience spans leading complex clinical trials, enhancing trial efficiency, exhibiting expert oversight, and GCP adherence. Recognized for implementing innovative solutions and fostering strong site relationships, I drive project success and compliance.
Overview
11
11
years of professional experience
Work History
Senior Clinical Research Associate I
ICON
04.2022 - 10.2024
- Verified informed consent procedures and protocol had been performed in accordance to applicable regulations.
- Maintained the integrity of clinical data while the study was conducted in compliance with approved protocol, GCP, applicable regulations and SOPs.
- Managed the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
- Verified proper management and accountability of Investigational Product (IP).
- Wrote and submitted reports of investigational site findings and updated applicable tracking systems.
- Managed essential documents as required by local regulations and ICH-GCP guidelines before, during and after a clinical study.
- Independently conducted initiation, monitoring, and closeout visits in accordance with all ICH-GCP guidelines, applicable regulations, SOPs and study processes.
- May be assigned studies that require complex therapeutic knowledge.
- KEY CONTRIBUTIONS: Successfully completed the Oncology University Fundamentals Program, which consisted of 30 hours of online training on cancer topics through the internal PRA-LMS and 15 hours of instructor-led remote training designed to explore aspects of basic oncology monitoring with monitoring simulation activities. Provided corrective and preventative actions (CAPAs) after independently assessing risk at the site level and escalated as applicable. Worked closely with sites in assisting various site staff with resolution of investigational site/data queries. Most sites managed met targeted enrollment and/or exceeded enrollment, showed adequate PI oversight, and all TMF documents kept current and up-to-date.
Clinical Trial Visit Leader
ICON
04.2022 - 10.2024
- Conducted regular site visits to oversee CRAs with less than 2 years of experience to support trial operations firsthand, ensuring proper execution of protocols.
- Identified potential investigators and clinical sites for study start up (SSU) initiatives.
- Developed robust data management plan(s) to ensure accurate recordkeeping throughout the study lifecycle.
- KEY CONTRIBUTIONS: Provided training and coaching feedback as a mentor and visit leader for green CRAs. Championed patient safety by implementing monitoring procedures and promptly addressing any concerns or adverse events. Mentored an upward of 10 CRAs how to improve clinical trial efficiency by streamlining processes and implementing quality control measures.
Senior Clinical Research Associate I
Piper Companies (PRA/ICON)
02.2022 - 04.2022
- Site management, co-monitoring or primary, and site liaison to investigator sites.
- Monitored patient safety and protocol violations.
- Monitored and maintained ICH-GCP compliance.
Clinical Research Associate II
Premier Research
09.2020 - 02.2022
- Delivered quality, timely, monitoring reports for sponsor approval per the Clinical Monitoring Plan (CMP) timelines.
- Responsible for the validity, correctness, and completeness of the clinical data reviewed and collected at assigned sites as dictated by ICH GCP/ISO14155, protocol and client requirements.
- Monitored (remote, on-site or other approved mode of monitoring) with a focus on data integrity and patient safety in accordance with specific country regulations.
- KEY CONTRIBUTIONS: Maintained communication with study sites as directed per CMP. Through feasibility, pre-study site visits, and collection of data, assisted in selecting final sites selected for studies. Consistently met deliverables of assigned projects and helped to mitigate relative risks with potential patient population and patient safety.
Clinical Research Associate II
Syneos Health (formerly InVentiv)
10.2019 - 08.2020
- Administered protocol and study-related training to assigned sites and established lines of communication with sites to manage ongoing project expectations and issues.
- Performed Site Selection, Initiation, Interim Monitoring visits as assigned study teams were in startup.
- Ensured the safety of study subjects with ever-changing study needs per COVID-19 global pandemic.
- Conducted additional on-site and remote visits in accordance to edited clinical monitoring plan (CMP) guidelines per COVID-19 global pandemic.
- KEY CONTRIBUTIONS: Provided timely and accurate visit reports and maintained a 100% visit report metric in accordance to sponsor's 3-day turnaround time for drafts and 7-day turnaround for finalizations.
Clinical Research Associate I/II
Parexel
05.2015 - 10.2019
- Assessed investigational products through physical record review.
- Maintained regular contact between monitoring visits with investigative sites to confirm protocol is being followed, previously identified issues were being resolved, and dates were being recorded in a timely manner.
- Initiated clinical trial sites according to the relevant procedures to ensure compliance with the protocol, regulatory and ICH/GCP guidelines, and made recommendations where warranted.
- KEY CONTRIBUTIONS: Recognized and escalated deficiencies, as applicable. Presented potential solutions for deficiencies and followed all issues through to resolution. Facilitated effective communication between investigative sites, clients/team through oral, written, and electronic contacts.
Research Coordinator
Bay Area Regional Medical Center
08.2013 - 05.2015
- Participated in study recruitments to ensure recruitment goals were exceeded and generated reports for supervisor on patient enrollment and tracking.
- Adhered to ICH GCP, HIPAA, FDA regulations, and SOPs and maintained ongoing regulatory docs.
- Responsible for the completion of case report forms, ensured accuracy of data, and reported adverse events to sponsors.
- Responsible for drug accountability and maintained logs and inventory of study products and supplies.
- KEY CONTRIBUTIONS: Became a lead research coordinator in 6 months and was the site's primary study contact. Ensured that study related reports and patients' results were reviewed by an investigator in a timely manner. Worked most closely to PI and Sub-I team(s) on assigned studies.
Education
Bachelor of Science - Marketing
George Mason University
Fairfax, VA05.2013
Skills
- Employee Supervision
- Client Relationship Management
- Staff Training/ Coaching
- Operations Management
- Good Clinical Practice (GCP)
- Contract Research Organization (CRO)
- Visit Sign Offs
- Complex Problem-solving
Protocol Experience
- Cardio-Metabolic/ Obesity, phase II
- Dermatology/ Atopic Dermatitis, phase III
- Hepatology/ Liver Disease, phase II
- Hepatology/ NASH, phase III
- Neurology/ ADHD, phase III
- Neurology/ Pain/ Migraine, phase II
- Oncology/ Solid Tumors, phase II
- Oncology/ Solid Tumors/ Multiple Solid Tumors, phase I
- Oncology/ Solid Tumors/ NSCLC, phase I/II/III
- Psychiatry/ ADHD | phase III
- Psychiatry/ Anorexia | Bulimia | Binge Eating, phase II
- Psychiatry/ Bipolar Disorder, phase I/II
- Psychiatry/ Borderline Personality Disorder, phase III
- Psychiatry/ Major Depressive Disorder, phase II
- Psychiatry/ PTSD, phase II
- Psychiatry/ Schizoaffective Disorder, phase II/III
Vendor Experience
Almac IVRS | Mobile Health Platform (MHP) | iMedidata | Advarra central IRB | Suvoda IRT | Endpoint IRT | ONCO EMR | iKnowMed EMR | Florence eReg | Trial Interactive | CRIO EMR | COMPLION eReg | IMPACT CTMS | Medidata CTMS | Medidata RAVE | Veeva Vault eTMF | Phlex eTMF
Timeline
Clinical Trial Visit Leader
ICON
04.2022 - 10.2024
Senior Clinical Research Associate I
ICON
04.2022 - 10.2024
Senior Clinical Research Associate I
Piper Companies (PRA/ICON)
02.2022 - 04.2022
Clinical Research Associate II
Premier Research
09.2020 - 02.2022
Clinical Research Associate II
Syneos Health (formerly InVentiv)
10.2019 - 08.2020
Clinical Research Associate I/II
Parexel
05.2015 - 10.2019
Research Coordinator
Bay Area Regional Medical Center
08.2013 - 05.2015
Bachelor of Science - Marketing
George Mason University
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