Summary
Overview
Work History
Education
Skills
Research Experience
Timeline
Generic

Kirsten Gordon

Philadelphia,PA

Summary

Experienced Clinical Trials Professional with over 5 years of expertise in managing and coordinating oncology, vaccine, and general medication trials. Proven track record as a Data Manager, Clinical Trials Coordinator, and Site Manager. Currently contributing to the success of clinical trials at IQVIA. Adept at ensuring compliance with regulatory standards, fostering strong relationships with stakeholders, and optimizing trial processes for successful outcomes.

Overview

19
19
years of professional experience

Work History

Site Manager

AVACARE
11.2022 - Current
  • Organized project activities and deliverables, ensuring timely completion
  • Developed recruitment and retention plans for a predominantly Hispanic population
  • Conducted quarterly performance reviews and provided constructive feedback
  • Fostered business relationships and ensured compliance with protocols and regulations
  • Monitored CRF data entry, query status, and SAEs, ensuring data accuracy
  • Conducted site qualification, initiation, monitoring, and termination
  • Participated in meetings, audits, and regulatory inspections
  • Screened potential subjects and maintained strong relationships with investigators and site staff

Clinical Trials Coordinator

Fox Chase Cancer Center
05.2021 - 11.2022
  • Maintained regulatory documentation and ensured Good Clinical Practice
  • Assisted in recruitment and monitored research participants
  • Operated EMR systems and collaborated on audit findings and corrective actions
  • Communicated study requirements to research teams and participants
  • Ensured adherence to study parameters and FDA guidelines
  • Managed study supplies and equipment, and developed treatment protocol calendars
  • Mentored new CRNs and CRCs, and developed SOPs for training

Clinical Trial Coordinator II

Jefferson CRO-Melanoma
07.2019 - 05.2021
  • Maintained regulatory documentation and ensured compliance with IRB and FDA standards
  • Coordinated external monitoring visits and communicated with sponsors regarding study updates and data queries
  • Managed data collection strategies and query resolution for multiple trials
  • Created source documentation and prepared quarterly safety reports
  • Operated EMR systems and navigated multiple Electronic Data Capture systems

Medical Assistant

Jefferson Medical Oncology-Melanoma
Philadelphia
06.2018 - 07.2019
  • Obtained vitals, patient histories, and performed EKGs, glucose monitoring, and phlebotomy
  • Assisted with outpatient procedures and provided emotional support to patients
  • Scheduled appointments and testing in EPIC and registered new oncology patients
  • Participated in team meetings and multidisciplinary meetings

Medical Assistant

Ritner Medical Associates
Philadelphia
10.2016 - 06.2018
  • Maintained patient flow and assisted with quality forms and triaging patients
  • Performed EKGs, vaccination injections, and pulmonary function testing
  • Managed vaccine logs, ordered medical supplies, and communicated lab results to patients
  • Assisted with billing, coding, and reconciliation of labs in the EMR

Lead Medical Assistant

Frankie's World Medical Center
09.2014 - 05.2016
  • Led a team of Medical Assistants and Home Health Aides
  • Assisted nurses with patient care and communicated with patients and their families
  • Created educational materials and maintained patient charts

Board Member/Fundraising Coordinator

Prysm Youth Center
03.2012 - 09.2014
  • Coordinated and led fundraising efforts and facilitated weekly meetings for LGBT youth
  • Attended community events to promote and educate the public on youth LGBT issues

Data Entry

Holcomb Behavioral Health
06.2013 - 06.2014
  • Entered data from department programs and attended weekly meetings to review data
  • Filed paperwork and audited old files for shredding

Certified Medical Assistant

Children's Hospital of Philadelphia
05.2006 - 10.2011
  • Assisted physicians with patient assessments and performed EKGs and vaccination injections
  • Maintained vaccine logs and created computer applications for record keeping
  • Developed patient education handouts and coordinated appointments for patients

Education

Certified Medical Assistant -

PC Age
Edison, NJ
01.2006

diploma -

Hillsborough High School
Hillsborough, New Jersey
01.1999

bachelor’s degree -

Thomas Jefferson University
Philadelphia, PA

Skills

  • Excel
  • MS Teams
  • Outlook
  • PowerPoint
  • Word
  • EPIC
  • BEACON Build templates
  • EClinical Works
  • RedCap
  • RAVE
  • InForm
  • OnCore
  • Veeva Vault
  • Signant Health
  • Flat Iron
  • Study Kik
  • Project management
  • Regulatory compliance
  • Data management
  • Recruitment strategies
  • Performance evaluation
  • Good clinical practice

Research Experience

· Informed choice Intervention for Colorectal Cancer Screening; Sponsor Exact Sciences

· Roche Cancer Screening Collection Study; Sponsor Roche- Site Manager and Lead CRC

· A Phase1/2 Randomized, Observer-blind, Active-Control Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA- based Influenza and SARS-CoV2 Multi-component Vaccines in Healthy Adults; Sponsor Moderna

· A randomized, double-blind, placebo-controlled, multicenter trial, assessing the impact of inclisiran on major adverse cardiovascular events in participants with established cardiovascular disease (VICTORION-2 PREVENT)- Sponsored by Novartis

· A Phase IV Study to Assess the Effect of Naltrexone Hydrochloride Extended Release (ER) and Bupropion Hydrochloride ER Combination (Contrave®/Mysimba®) on the Occurrence of Major Adverse Cardiovascular Events; Sponsor Currax

· A Phase 1/2, randomized, observer-blind, dosefinding/dose-confirmation study to evaluate the safety, reactogenicity and immunogenicity of the mRNA-based investigational pandemic H5 influenza vaccine candidate administered in healthy younger and older adults; Sponsor GSK

• Phase II Study of Organ Preservation in Early Rectal Cancer Patients; Sponsored by Fox Chase Cancer Center- Coordinator

• Gemcitabine & Nab-Paclitaxel w/5-Fluorouracil, Leucovorin Liposomal Irinotecan in Older Patients (GIANT), Sponsored by ECOG-ACRIN, Coordinator

• Phase I Study of Neoadjuvant Pulsed Low Dose Rate Radiation with Concurrent Chemotherapy for Non-Small Cell Lung Cancer and Esophageal Cancer, Sponsored by Fox Chase Cancer Center

• INCB054828 vs Chemo in Unresectable or Metastatic Cholangiocarcinoma with FGFR2, Sponsored by Incyte, Coordinator

• A Phase II/III trial of Neoadjuvant FOLFOX, with Selective Use of Combined Modality Chemoradiation, Sponsored by Alliance, Coordinator

• Study of Nivolumab or Placebo in with Resected Lower Esophageal or Gastroesophageal Junction, Sponsored by Bristol Myers Squibb, Coordinator

● A Randomized Phase II Study of Adjuvant Sunitinib or Valproic Acid in High-Risk Patients with Uveal Melanoma; Sponsored by Thomas Jefferson University and Pfizer –Lead Data Manager

● APG-115-US-002 A Phase Ib/II study of APG-115 in combination with Pembrolizumab in patients with unresectable or Metastatic Melanomas or Advanced Solid Tumors; Sponsored by Ascentage Pharma Group Inc. – Lead Data Manager

● Verastem: A Phase II trial of Defactinib (VS-6063) combined with VS-6766 (CH5126766) in patients with metastatic uveal melanoma; Sponsored by Thomas Jefferson University - Lead Data Manger

● Delcath: A Single-arm, Multi-Center, Open-Label Study to Evaluate the Efficacy,

Safety and Pharmacokinetics of Melphalan/HDS Treatment in Patients with

Hepatic-Dominant Ocular Melanoma – Lead Data Manager

Timeline

Site Manager

AVACARE
11.2022 - Current

Clinical Trials Coordinator

Fox Chase Cancer Center
05.2021 - 11.2022

Clinical Trial Coordinator II

Jefferson CRO-Melanoma
07.2019 - 05.2021

Medical Assistant

Jefferson Medical Oncology-Melanoma
06.2018 - 07.2019

Medical Assistant

Ritner Medical Associates
10.2016 - 06.2018

Lead Medical Assistant

Frankie's World Medical Center
09.2014 - 05.2016

Data Entry

Holcomb Behavioral Health
06.2013 - 06.2014

Board Member/Fundraising Coordinator

Prysm Youth Center
03.2012 - 09.2014

Certified Medical Assistant

Children's Hospital of Philadelphia
05.2006 - 10.2011

Certified Medical Assistant -

PC Age

diploma -

Hillsborough High School

bachelor’s degree -

Thomas Jefferson University
Kirsten Gordon