Summary
Overview
Work History
Education
Skills
Accomplishments
Therapeutic Experience
Timeline
Hi, I’m

Christina Norwood

Slidell,LA
Christina Norwood

Summary

  • Dedicated 10 year experienced CRA/In-House CRA in the Contract Research Organization (CRO) Industry
  • Expert across several phases of studies inclusive over several therapeutic areas and indications.
  • Vast knowledge in managing the TMF ensuring inspection readiness, study start-up, and eTMF management over multiple study projects to ensure quality assurance and Regulatory documents are in compliance.

Overview

11
years of professional experience

Work History

Novartis Pharmaceuticals
Morristown, NJ

Site Support Lead
04.2022 - Current

Job overview

  • Drive proactive risk mitigation and effective startup scenario generation and planning through data driven analysis utilizing internal and external data sources
  • Manages all drug supply management from tracking importation, inspection, delivery to depot and entry into inventory.
  • Drive and track confidentiality agreement collection as applicable.
  • In collaboration with Contracts & Payments team, drive Investigator/site contracts negotiation and execution.
  • Drive Preparation, filing, and quality check verification of start-up documents, including Country and site TMF.
  • Lead US study start-up meetings with CRAs, CRA Managers, and CSM as applicable and coordinates Site Initiation planning.
  • Track milestones and analyses US study start-up data (metrics) of TMF on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement. Provide CSM and Global team regular study start-up update including KPI and mitigation actions.



Syneos Health
Morrisville, NC

CRA II
11.2018 - 04.2022

Job overview


  • Performs site qualification, site initiation, interim monitoring, site management activities and close-out visits (performed on-site or remotely) ensuring regulatory, ICH-GCP and/or Good Pharmacoepidemiology Practice (GPP) and protocol compliance
  • Verifies process of obtaining informed consent has been adequately performed and documented for each subject/patient, as required/appropriate
  • Routinely reviews Investigator Site File (ISF) for accuracy, timeliness, and completeness. Managed quality and reconciles contents of ISF with Trial Master File (TMF)
  • Ensures investigator/physician site is aware of requirement of archiving essential documents in accordance with local guidelines and regulations
  • For assigned activities, understands project scope, budgets, and timelines; manages site-level activities / communication to ensure project objectives, deliverables and timelines are met
  • Provides guidance at site and project level towards audit readiness standards and supports preparation for audit and required follow-up actions


Syneos Health
Morrisville, NC

TMF Specialist
11.2019 - 04.2022

Job overview

  • Supports TMF Management by contributing to customer solutions/proposals and any associated Costing
  • Drives consistent TMF set-up, structure, and completeness reports
  • Actively involved in risk management/mitigation to ensure high-quality audit ready TMF
  • Designs and/or delivers study specific TMF training in various formats via teleconference, video conference, and/or in person
  • Prepares and participates in audits/inspections to ensure ongoing readiness of TMF
  • Provides regular feedback to Project Team on TMF health/status including actionable metrics for projects/program as necessary, provided re-training to Project Team
  • Presents assigned projects/programs current TMF status, risks, issues, and associated actions
  • Represents TMF QC/Completeness Review, and oversees TMF
  • Liaise with department management to monitor TMF team performance to budget and document any out-of-scope work in Change Notification Form/Change Orders as required
  • Develops and enhances training material applicable to TMF Lead responsibilities for departments


Premier Research
Morrisville, NC

CRA II
03.2018 - 11.2018

Job overview

  • Monitors (remote, onsite or other approved mode of monitoring) with focus on data integrity and patient safety in accordance with specific country regulations -
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Facilitated quality of TMF by establishing project schedules and monitoring support to encourage accuracy and efficiency.
  • Takes initiative to move project/program forward by reducing backlog and keeping it at a minimum - Monitors with knowledge of quality/scope and budget parameters
  • - Escalates issues and feedback for the team - Works with Clinical Manager (CM) to enhance and proactively manage site visits and trial issues during monitoring phase
  • Assists project team with assessing project feasibility and recruitment, as applicable
  • Maintains project tracking system of subjects and site information as applicable
  • Manages investigative sites via telephone calls between visits Ensures adherence to study timeline and budget

Parexel

CRA
04.2014 - 03.2018

Job overview

  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.

Education

American Sentinel University
Aurora

Master of Business Administration
2021

University of New Orleans
New Orleans, LA

Bachelor from Psychology
2008

Skills

  • Schematics Interpretation
  • Video Conferencing
  • Project Records
  • Overseeing quality assurance of TMF
  • Highly skilled in VeevaVault, Trial Interactive and Florence

Accomplishments

  • Management of eTMF across 30 clinical studies
  • Documented and resolved TMF quality assurance management which led to no audits


Therapeutic Experience

Cardiovascular
-Hypertension -
-Myocardial Infarction
Hematology -
-Aplastic/hypoplastic anemia
Immunology / Inflammatory
-Ankylosing Spondylitis
-Sjogren Syndrome
Infectious Disease
Human Immunodeficiency Virus

-Rare Disease
Inflammatory Diseases

-Arthritis
Oncology
-Cancer, B -Cell Lymphoma

-Breast Cancer

-Non-Hodgkin's Lymphoma

-Adenocarcinoma

-Thyroid cancer

Psychiatry

-Schizophrenia

Timeline

Site Support Lead

Novartis Pharmaceuticals
04.2022 - Current

TMF Specialist

Syneos Health
11.2019 - 04.2022

CRA II

Syneos Health
11.2018 - 04.2022

CRA II

Premier Research
03.2018 - 11.2018

CRA

Parexel
04.2014 - 03.2018

American Sentinel University

Master of Business Administration

University of New Orleans

Bachelor from Psychology

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Christina Norwood