Clinical Research Project Manager

Johnson_Shanda_**-Jan-****’ Page * of *

Shanda Johnson

Sr. CRA

ICON Clinical Research

Wylie, TX, USA

Education

Collin College

Associate of Science Degree

Major: Respiratory Therapy

American Intercontinental University

Bachelor of Science

Major: Healthcare Administration

University of Texas at Arlington

Master of Science

Major: Healthcare Administration

Summary

Over 20 years of experience working in clinical research with over 5 years of experience as CRA

Clinical Research Therapeutic Areas include:

Indication Phase I, II, III, or IV Highest Role Within Indication

Cardiology II, III Sr. CRA

Dermatology III CRA II

Neurology II, III, IV SR. CRA, Manager

Endocrinology II, III CRA I

Genetics II, III CRA I

Infectious Disease II, III CRA II

Respiratory II, III CRA II

Head and Neck Oncology II, III Manager

Melanoma II, III Manager

Sarcoma II, III Manager

Neuro Oncology I, II, III, IV Sr. CRA, Manager

Professional Licenses/Affiliations/Memberships:

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American Heart Association BLS Instructor

Society of Clinical Research Associates

National Board of Respiratory Therapy

Licensed Registered Respiratory Therapist

Experience in Electronic Data Capture trials:

RAVE, CSIV, InVicro, Quentry, InForm, REDCap, Citrix, Medidata, IMPACT, BioClinical

Languages (fluency, verbal and written): English Johnson_Shanda_17-Jan-2023 Page 3 of 5

Professional Experience

ICON Clinical Research

Sr. CRA

January 2023

Job Description

Study Assignments

Role(s): Sr. CRA Period(s):

Jan 2023- Current

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs,

applicable regulations and the principles of ICH-GCP. Depending upon experience, become involved when

required in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate. Provide a benchmark of

monitoring competence to inexperienced / less

experienced colleagues.

Role(s):

Sr. CRA

Period(s):

Jan 2023 – Current

Project Description

1. Unblinded Sr. CRA (Jan 2023 – July 2023)

Protocol 80202135SJS2001:A Randomized,

Placebo-Controlled, Double-Blind, Multicenter

Study to assess the efficacy of Nipocalimab in

Subjects with Primary Sjogren's Syndrome (pSjS).

2. Blinded Sr. CRA (Jan 2023 – present)

Protocol MOM-M281-006: Efficacy and Safety of

M281 in Adults with Warm Autoimmune Hemolytic

Anemia: A Multicenter, Randomized, Double-blind,

Placebo-controlled Study with a Long-term Open-

label Extension

3. Blinded Sr. CRA (Jan 2023 – present)

Protocol VAC52416BAC3001: Efficacy and Safety

of M281 in Adults with Warm Autoimmune

Hemolytic Anemia: A Multicenter, Randomized,

Double blind, Placebo controlled Study with a

Long-term Open-label Extension Randomized,

Double-Blind, Placebo-controlled, Multicenter Ph 3 Study to Assess the Efficacy, Safety And

Immunogenicity of Vaccination With ExPEC9V in

the Prevention of Invasive Extraintestinal

Pathogenic E-coli in Adults over 60 with a History of UTI

Johnson_Shanda_17-Jan-2023 Page 4 of 5

Plus Therapeutics

Contract Consultant

Jan 2022 to Dec 2022

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, applicable regulations and the principles of ICH-GCP, and encourage patient recruitment suggesting strategies as appropriate per study sponsor. Assist with all protocol submissions at a sponsor level, create source documents, point of contact with study vendors, ensure all site study team members had proper access to all required study systems, assist with budget creation and negotiations between the sponsor and sites, created newsletters/training slides/training documents, and facilitated presentations.

UT Southwestern Medical Center of Dallas

Clinical Research Manager

Apr 2019 to Oct 2021

Review proposed trials and present to the entire study team, review and negotiate budgets, oversees preparation of all IRB documents, ensure all CITI and regulatory trainings are up to date with the entire study team, ensure FDA compliance and all other regulatory entities, oversee all ongoing research projects by the team and monitor profitability, direct oversight of the projects finances and invoices for payment, ensure training of the study staff, oversee marketing strategies, maintain collaborative relationship with the study team and basic science facilities, and oversee the immediate study team members.

United BioSource Corporation

Sr. CRA

May 2017 to May 2019

Identify, select, initiate and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol and in accordance with UBC SOPs, applicable regulations and the principles of ICH-GCP, and encourage patient recruitment suggesting strategies as appropriate per study sponsor, Provide a benchmark of monitoring competence to inexperienced / less experienced colleagues.

Quintiles IMS

Sr. CRA

November 2015 to May 2017

Identify, select, initiate, and close-out appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, Quintiles SOPs/WPs, applicable regulations and the principles of ICH-GCP. Depending upon experience, become involved when required in other areas of study management and staff training and contribute to the review of Quintiles systems and procedures as appropriate, and encourage patient recruitment suggesting strategies as appropriate per study sponsor,

Childrens Medical Center of

Dallas

Clinical Research Coordinator

October 2005 to November 2015

Facilitate in research protocol evaluation and implementation, evaluate study coverage analysis and study feasibility, execute study start-up and close-out procedures, patient recruitment and study Johnson_Shanda_17-Jan-2023 Page 5 of 5

follow-up, study record maintenance including patient binders and regulatory binders, IRB regulatory study submission, working relationship with sponsors acting as a liaison with the PI’s, precepting new Study Coordinators, and assist with Research Workshops and Conferences

Publications:

N/A

Contact this candidate