Research Coordinator Clinical

Shannon N. Williams

Professional Summary: I’m an accomplished and energetic onsite clinical specialist that’s adept at managing the provision of individual patient services. I continuously coordinate and collaborate with surgeons and management to ensure adherence of established policies, procedures, compliance and regulations that adheres to the company vision, mission, values and core beliefs. Education

LPN Technical Certificate - Delgado Community College - July 2014 High School Diploma - Francis T. Nicholls - May 1988 Licenses Certifications Trainings

● Laser/Tech 05184 - State of Louisiana - April 2021

● LVN/ 240400 - State of California - December 2018 (

● LPN/240993 - State of Louisiana - December 2013

● Good Clinical Practice (CITI) 2021

● Human Subject Protection (ACRP) 2021

● Dangerous Goods Shipping (Mayo Clinic) 2021

● FibroScan (Objective Health) 2021

● CPR (American Health Association) 2019

Therapeutic Areas of Expertise

Pharmaceutical-Sponsored Drug Trials (Phases I-IV)

● Oncology, Vaccines (Covid-19)

Professional Experience

Objective Health DePaul Center for Clinical Research Clinical Research Coordinator October 2022 - Present

● Works closely with Supervisor, Russell Herstein, Research Assistants and Principal Investigators on the trails

● Identify and pre-screen patients and participants for clinical trials

● Comprehensively managed study participants to ensure their safety throughout the study

● Perform chart review for I/E criterias

● Ensure each study participants are fully informed of the specific study at the time of the consent

● Walk each patient through the Informed Consent Process to ensure they fully understand what is required of them during the study or trial

● Create source documents for study visits

● Communicate with PI, sponsors, staff and upper management on any protocol changes and the health of each study

● Data collection, entry and analysis of data

● Maintain all study files by keeping regulatory binders up to date

● Perform basic and routine nursing care by conducting clinical procedures such as vital signs, phlebotomy, EKGs and/or bladder scans, and other necessary medical assessments

● Schedule all follow up appointments

● Establish an open dialog with participants to build trust and compliances

● Explain in depth the purpose of specific research projects participant may qualify for

● Document participant concerns via calls, emails, and voice messages

● Document response into EMR and gather necessary documents for review, audits and IRB submissions

● Notify PI and document potential adverse reactions and unusual behaviors that has the potential to alter study

● Upload data into EMR and facility backup systems and collaborate with participants at their level of education and ability to fully understand the process.

● Treat all participants with gratitude, respect and courtesy at all times Agiliti Surgical Services - New Orleans, LA

Laser Technician February 2021 August 2022

RFL: I decided to work this job while I was looking for work in Clinical Research. During my time here, I also had knee replacement surgery and needed to take time away to recover. After recovery, I devoted my time into finding a job in clinical research again; I eventually found an opportunity with Objective Health

● Worked closely with Supervisor, Brandon Luster

● Deliver equipment to operating rooms for scheduled or standby cases

● Ensure equipment is in ready position prior to surgical procedure

● Test, clean and sterilize equipment

● Present in operating room to operate equipment and readily answer any physician questions

● Perform specific calibrations and ensure equipment is properly functioning properly

● Transport equipment to appropriate facilities prior to cases

● Check all probes, filters, monitors, breakers, etc.

● Process, package and store equipment according to invoice

● Conduct detailed patient assessments

Benchmark Research - Metairie, LA

Unblinded Clinical Research Coordinator March 2019 - November 2019 RFL: Pfzier and Moderna were the 2 sponsors on the trials, but then Moderna pulled their study. Pfizer also downsized from 2 locations to 1 location, which was too far of a commute for me at this time as I had no reliable transportation. After this opportunity did not work out, I stayed with my son while I was actively getting my LVN license in Louisiana while my mother was also diagnosed with a critical illness.

● Worked closely with Supervisor, Kyra Lawson

● Follow SOP, OSHA, HIPPA, FDA, GCP, CLIA, state, federal guidelines and facility policies ensure the integrity chain of custody regulations

● Review chart to include (H&P, past MH, meds, labs, cultures), etc.

● Verify consents

● Conduct detailed patient assessments

● Perform specific protocol procedures as outlined by compliance investigations

● Perform IM vaccinations

● Ensure each study participant is fully informed of the study at the time of the consent

● Schedule screenings and follow up visits

● Maintain confidentiality of sensitive information

● Coordinating the daily clinical activities of participants enrolled in clinical trials

● Ensure compliance with institutional IRB, FDA, and sponsor guidelines/ regulations and standard operating procedures requirements

● Demonstrate professional demeanor and maintain confidentiality in all interactions with both internal and external contacts

Cupertino Healthcare and Wellness Center - Cupertino, LA Charge Nurse March 2016 February 2018

RFL: After moving from CA to LA, I decided work this job while looking for work in Clinical Research; I eventually found a job opportunity working with Benchmark Research

● Worked closely with Supervisor, Christina Serio

● Document all required records r/t informed procedures

● Receive verbal orders from attending physician and nursing staff regarding equipment

● Provide optimal customer services on equipment

● Complete requisition and arrange for diagnostic and therapeutic services as ordered by physician

● Assist with in services and training on new and/or updated surgical equipment and supplies

● Maintain effective communication with internal and external partners

● Assist physicians using various types of equipment

● Complete, review and maintain data on purchasing orders Golden Shore Medical Group - Pasadena, CA

Clinical Research Assistant (Blinded and Unblinded Trials) March 2013 - July 2015 RFL: Golden Shore was getting ready to close down permanently (irregularities that needed to be resolved); I moved to CA to LA to continue pursuing work in Clinical Research

● Supervisor: Gwendolyn Porter 317-***-****)

● Establish and organize study files; regulatory binders; case report forms; enrollment logs and case report forms

● Record adverse event and side effect data and confer with PI regarding the reporting of events to oversight agencies

● Prepare all documents related to the informed consent process

● Communicate protocol problems to PI and assist in problem resolution efforts such as protocol revisions

● Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports

● Assist PI in protecting the rights and welfare of all human research participants involved in research in accordance with federal regulations and university, sponsoring agency

● Conduct procedures vital signs; blood draws; EKGs; bladder scans if seen by a physician

● Collect ancillary supplies; lab kits; investigational medicine from sponsors and ensure everything is accounted for

● Adhere to guidelines of GCP, FDA, SOP, state and federal guidelines and protocols

● Plan and schedule tasks and projects and complete them in a timely manner

● Maintain confidentiality of sensitive information LHC/ Ochsner Home Health

Field Licensed Practical Nurse November 2010 - September 2013 RFL: I moved from LA to CA to pursue a job in Clinical Research

● Worked closely with Supervisor, Toya Brown

● Provide skilled nursing interventions and care according to the plan of care

● Apply knowledge and skills in accordance with accepted standards of clinical practice to facilitate problem resolution and achieve individualized patient goals

● Perform wound care r/t skin tears, pressure ulcers, wound vac, etc.

● Participate in QA/QI process

● Observe records and reports to the supervising nurse and/ or physician patient process to treatment and changes in the patient’s condition

● Participate in Care Management process

● All other assigned duties

Clinical Research Studies

● Protocol C4591001(COVID-19)

● Protocol MRNA-1273-P301 (COVID-19)

● Protocol GO44296 V1- Roche Cancer Screening Study: A Blood-Based Assay For Cancer Screening, Which Can Lead To Earlier Detection Of Cancers, Can Address The Unmet Need Of Expanding Cancer Screening And Overcoming The Low Uptake Of Screening Among Screen-Eligible Populations.

● 2021-C4591001: A Phase 1/2/3, Placebo-Controlled, Randomized, Observer Blind, Dose- Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And Efficacy of SARS-COV-2 RNA Vaccine Candidates Against COVID-19 In Healthy Individuals

● 2020-mRNA-1273-P301: A Phase 3, Randomized, Stratified, Observer- Blind, Placebo Controlled Study To Evaluate The Efficacy, Safety, And Immunogenicity of mRNA-1273-SARS-COV-2 In Healthy Individuals

● 2021-xxx Clinical Research Coordinator/Blinded - A Phase 1/2/3, Placebo-Controlled, Randomized, Observer-Blind, Dose-Finding Study To Evaluate The Safety, Tolerability, Immunogenicity, And Efficacy of XXX Vaccine Candidates Against COVID-19 In Healthy Individuals

● 2020-xxx Clinical Research Coordinator/Blinded - A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study To Evaluate The Efficacy, Safety, And Immunogenicity of XXX Vaccine In Adults Aged 18 Years And Older Relevant Skills

● Knowledge of GCP, IRB, protocol, state, federal guidelines

● Phlebotomy

● Perform Fibroscans

● Medical Terminology

● Perform EKG

● Obtained Informed Consent

● Data Collection and Analysis

● Effective SOP Execution

● Collect/Process Laboratory/PK/Biological Samples

● Holmium YAG Laser

● Dispense Investigational Product

● Storage and Accountability of IP

● Administer SubQ/IM injections

● eSource

● Demonstrate knowledge and proficiency in the principles, procedures and best practices

● Demonstrate the ability to perform general nursing duties as outlined by plan of care

● Knowledge of computer skills

● Demonstrate good leadership ability with good oral and written communication skills

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