Shalonda R. W. Scott

*** ********* ***** *****

St. Louis, MO 63146

314-***-****

abgwvn@r.postjobfree.com

EDUCATION: University of Phoenix, St. Louis, MO

Doctorate of Health Administration, May 2014

Washington University, St. Louis, MO

Master of Arts, May 2007

Biology (3.6 GPA)

Dillard University, New Orleans, LA

Bachelor of Science May 2003

Biology (pre-medicine track), minor in Chemistry (3.4 GPA)

PROFESSIONAL SKILLS:

. Eleven years research

. Seven years laboratory experience

. Skilled in using PC, Microsoft Office (Word, Access,

PowerPoint, Visio, Project, Outlook and Excel), Lotus

Notes, WordPerfect, Internet Explorer, Oracle, Netscape,

Windows

. Type approximately 55-60 wpm at 95-97% accuracy

. Knowledge of GCP, ICH, FDA drug regulations, and IND

regulations

. Extensive training in conducting and implementing

clinical trials

. Indications include: Dialysis, Cardiac Failure, Asthma,

Hypo/Hyperlipidemia, Hypercholesterolemia,

Osteoarthritis, Obesity, Psoriasis, Psoriatic Arthritis,

Alzheimer's Disease/Dementia, Gout, Familial Autoimmune

Diseases, Irritable Bowel Syndrome, Oncology, Vaccines,

Cardiovascular, and Women's Health

EXPERIENCE:

Jun. 2009-present Quintiles Transnational-St. Louis, MO (homebased)

Clinical Site Manager/Sr. CRA/Lead CRA

. Perform site selection, initiation, monitoring and close-

out visits in accordance with contracted scope of work

and good clinical practice

. Provide monitoring visits and site management for a

variety of protocols, sites and therapeutic areas.

. Administer protocol and related study training to

assigned sites and establish regular lines of

communication with sites to manage ongoing project

expectations and issues.

. Evaluate the quality and integrity of study site

practices related to the proper conduct of the protocol

and adherence to applicable regulations.

. Manage the progress of assigned studies by tracking

regulatory submissions and approvals, recruitment and

enrollment, case report form (CRF) completion and

submission, and data query generation and resolution.

. Create and maintain appropriate documentation regarding

site management, monitoring visit findings and action

plans by submitting regular visit reports and other

required study documentation.

. Act as a mentor for clinical staff including conducting

co-monitoring and training visits.

. May provide assistance to the CTL with design of study

tools, documents and processes.

. Review and provide feedback on the protocol, amendments,

monitoring plan, the CRFs, the CRF completion

guidelines, and the edit checks

. Monitoring plan development activities limited to review

of portion of plan for US and providing feedback to COM

. Provide study specific monitoring tools - in conjunction

with COM, create the monitoring tools, monitoring

procedures and processes

. Creation of 'procedures and processes' would be focused

on best practices from a monitoring perspective

. Attend Investigator Meeting with the COM

. Meet with COM via teleconference on a regular basis to

review study issues and discuss general monitoring

issues/trends

. Biweekly meetings proposed, may be adjusted as mutually

agreed to

. Attend and participate on CRA Teleconferences with COM

. Participation would include updates on high level

monitoring trends or presentation on monitoring specific

issues/clarifications (not responsible for site updates

for colleagues, etc.)

. Offer agenda topics/input to agenda development

. Serve as a point person to CRA questions on

monitoring/study procedures.

. Address monitoring questions/clarifications

. Lead CRA should generate/maintain FAQ for monitoring

questions.

. As schedule/responsibilities permit, back up CRA(s) as

needed in getting queries resolved (via phone) during

crunch times (DBL, etc.),

. Serve as back-up to the COM for CRA questions when COM

is out/on vacation

. Lead CRA will be point person for CRA questions during

COM's absence and will triage questions to study team as

needed

Jan. 2010-April 2011 Vatterott Educational Centers, Inc.-St. Louis, MO

Adjunct Instructor

. Teaches college-level Anatomy and Physiology and Medical

Assisting, Medical Coding and Billing courses

. Follows the prepared class syllabus, outline and daily

lesson plans, and all online assignments. Maintains and

ensures consistency between the course catalog and the

daily lesson plans.

. Prepares and administers examinations, student projects,

discussions, and other online teaching aids needed to

fulfill objectives of the program

. Maintains accurate records of attendance, grades,

progress of students, and reports the same in a timely

manner to manager.

. Maintains a professional and positive tone in the online

learning environment.

. Attends all online scheduled in-service activities,

meetings, and completes all scheduled/assigned

activities in support of the individual faculty

development plan.

. Communicated budget needs to Campus Management in a

timely basis.

. Tutors and conducts advising conferences with students.

. Maintains discipline and enforces school rules and

regulations.

. Assists with library research needs and information

gathering and makes textbooks recommendations.

. Participates in committees, graduation ceremonies and

other school events as appropriate in the online

environment.

. Completes administrative duties and other projects as

assigned.

Nov. 2008-Jun. 2009 KV Pharmaceutical-St. Louis, MO

Clinical Affairs Coordinator

. Set-up, manage and maintain necessary and appropriate

clinical research study files in accordance with KV

SOP's and FDA, ICH and GCP guidelines or regulations.

. Participate in development of protocols, CRFs, ICFs, and

other clinical trial documents as appropriate.

. Track and report progress and metrics of assigned

project(s) and other internal or external clinical

project team members.

. Identify, document and evaluate project risks throughout

the project life cycle and implementing corrective

action as appropriate

. Oversee and manage day-to-day activities and tasks

performed by the internal project team or external

vendor(s) or combination thereof to ensure assigned

project(s) meet(s) quality, budget and timeline

specifications.

. Identify, qualify, contract and manage external vendors

as appropriate to perform/conduct project related tasks

or functions; US and abroad

. Track budget of assigned project(s) by maintaining

accurate and timely records of costs incurred and

payments made to investigational sites and other vendors

as appropriate.

. Assume primary responsibility for maintenance of

Clinical Affairs SOPs and develop internal processes

. Coordinate and prepare project status reports to insure

KV management is kept informed of project progress and

status.

. Establish a highly motivated and enthusiastic project

team, ensuring open communications and high quality

teamwork.

. Perform project quality control and quality

assurance/audit activities.

. Work in conjunction with 15 CRAs in making sure the

sites are in compliance with any regulations (company or

federal)

. Conduct regular project team meetings ensuring minutes

and action plans are prepared and circulated.

. Responsible for training for newly hired Clinical Trials

Administrators.

. Responsible for reviewing projects executed by other

Clinical Trials Administrators and

monitoring/supervising their daily tasks.

. Responsible for training CRAs and sites on protocol,

GCP, and clinical research related topics.

. Perform site visits and prepare visit reports

. Manage investigator and vendor grant payments.

Nov. 2007-Nov. 2008 KV Pharmaceutical-St. Louis, MO

Clinical Trials Administrator

. Clinical indications include Women's Health.

. Assisted clinical project team in identifying,

documenting and evaluating project risks throughout the

project life cycle and implementing corrective action as

appropriate

. Oversaw and managed day-to-day activities and tasks

performed by the internal project team or external

vendor(s) or combination thereof to ensure assigned

project(s) meet(s) quality, budget and timeline

specifications.

. Assisted Clinical Study Manager with set-up, planning,

implementing and delivering larger Phase III projects in

accordance with the scope of work as defined by the

project protocol, budget, timelines, goals, objectives

and KV management requirements.

. Assisted Study Manager in tracking budget of assigned

project(s) by maintaining accurate and timely records of

costs incurred and payments made to investigational

sites and other vendors as appropriate.

. Prepared project status reports to insure Study Manager

and KV management are kept informed of project progress

and status.

. Assisted in and performed quality control and quality

assurance activities as needed per the project.

. Responsible for maintaining multiple project tracking

systems that may include investigator payments.

. Responsible for training for newly hired Clinical Trials

Administrators.

. Responsible for reviewing projects executed by other

Clinical Trials Administrators and

monitoring/supervising their daily tasks.

. Worked with tracking mechanisms and processes for

shipping, inventorying, and storing documents and non-

drug clinical supplies

. Coordinated, prepared, and tracked the mailing and

return of regulatory documents and/or other

correspondence to and from the investigational sites.

. Responsible for the set up, maintenance and routine

quality checks/audits of the Trial Master File and other

study files to ensure SOP and GCP compliance.

. Participated in site-level and study level activities as

needed including pre-study activities, investigator

identification, site qualifications and initiation,

reviewing of study initiation documentation and site

approval, drug supply management, GCP compliance,

support group interactions, and study/site tracking to

ensure efficient and timely project start-up.

. Maintained detailed knowledge of GCPs, FDA regulations,

ICH Guidelines, SOPs, and protocol-related specifics.

Served as a resource for site personnel and the project

team.

. Designed, developed, and maintained various forms (ie,

CRF's, source documents, etc) for specific projects

. Provided input, draft, and develop process mapping and

SOPs for company processes.

. Responsible for identifying, qualifying, contracting and

managing external vendors (US and abroad) as appropriate

to perform/conduct project related tasks or functions

that are not performed within KV.

. Managed more than 80 sites at any given time to ensure

adequate supplies are present for the project, US and

abroad.

. Worked in conjunction with 15 CRAs in making sure the

sites are in compliance with any regulations (company or

federal)

. Conducted regular project team meetings ensuring minutes

and action plans are prepared and circulated.

. Analyzed data associated with various projects

Sept. 2007 - Nov. 2007 Radiant Research-St. Louis, MO

Clinical Research Coordinator

. Clinical indications included Osteoarthritis, obesity,

Alzheimer's Disease, Gout, Familial Autoimmune Diseases,

Irritable Bowel Syndrome

. Completed all data forms required by the study by

reviewing subjects' records and completing and updating

source documents

. Communicated with the physician, laboratory personnel,

and sponsor to ensure the protocol is being followed

appropriately

. Performed clinical procedures with the subjects

including EKG's, oral temperature measurements,

dispensing study medications, nutrition counseling and

blood pressure measurements

. Monitored and submitted paperwork needed for study

protocols such as serious adverse events and protocol

deviations

. Acted as a liaison between patient and investigators to

ensure continued patient participation in study

. Familiar with pre-site visits, site initiation visits,

monitoring visits, close-out visits and audits

. Completed electronic and paper CRFs; answer queries and

resolve issues

. Registered and randomized patients; and completed IVRS

procedures

. Experienced with Phases II - IV

. Responsible for scheduling patient visits

. Source verified CRFs and patient forms across various

studies to ensure proper documentation and completion of

documents.

. Coordinated 10+ studies at any given time

June 2006 to Aug 2007 Washington University School of Medicine-St. Louis,

MO

Department of Internal Medicine - Medical Oncology

Clinical Research Associate

. Coordinated all aspects of oncology research studies to

ensure successful implementation of the protocol for

multiple sites

. Reviewed medical charts to identify potential study

participants

. Performed internal audits to check for the compliance of

SOPs and GCP.

. Coordinated all aspects of specimen collection and

shipping

. Completed chemotherapy orders according to the

protocols.

. Completed all data forms required by the study by

reviewing the inpatient and outpatient medical records

and creating and updating source documents

. Communicated with the physician, sponsors, PI, and nurse

coordinator to ensure that the protocol is being

followed appropriately

. Assisted principal investigator in preparing reports for

the research study

. Monitored and submitted paperwork needed for study

protocols such as regulatory documents, patient

consents, protocol deviations and serious adverse events

. Acted as a liaison between patient and investigators to

ensure continued patient participation in study

. Familiar with pre-site visits, site initiation visits,

monitoring visits, close-out visits and audits

. Trained and supervised new coordinators

. Completed electronic and paper CRF

. Registered and randomize patients; answered queries and

resolved issues

. Experience with Phases II - IV

. Source verified CRFs and patient forms across various

studies to ensure proper documentation and completion of

documents.

. Coordinated 10+ studies at any given time

. Provided budget forecasts

. Monitored satellite sites

April 12, 2004 to June 1, 2006 Washington University School of Medicine

- Department of Radiology-Radiation Sciences-St. Louis,

MO

Research Coordinator

. Clinical indications included cardiovascular, diabetes,

obesity and normal volunteers

. Experience with Phase I - III

. Performed internal audits to check for the compliance of

SOPs and GCP.

. Assisted in clinical and animal studies by assisting

with patients, setting up PET (positron emission

tomography) suites for studies, and recording data

acquired during studies

. Performed extraction and analysis of image-derived data

using software developed by investigators in the

research group

. Executed the transfer of image and other data into

research databases for analysis for 9 research studies

. Assisted with the collection and interpretation of data

yielded by research studies for 7 investigators and

fellows

. Maintained organized and efficient records and databases

of data from 11 research studies, which includes

hundreds of individual research subjects.

. Implemented new and efficient strategies of maintaining

and managing data

. Ensured patients, technicians, and research staff were

well informed of the protocol requirements and remained

compliant

. Assisted in protocol development

. Assisted in preparing completed studies for publication

Aug. 2002 to Feb. 2003 Louisiana State University Health Sciences Center -

New Orleans, LA

Research Coordinator---Department of Otorhinolaryngology--

ENT

. Assessed videos taken of cell movement, recorded data

into databases and spreadsheets for more efficient

analysis

. Responsible for various solutions, using toxic and non-

toxic chemicals, needed for daily experiments

. Utilized various laboratory techniques including aseptic

techniques, measuring pH levels, quickly converting

measurements, pipetting, centrifugation, maintaining

equipment and sterilization of that equipment

. Worked safely with biological and chemical hazards under

a hood and ensured proper disposal

. Ensured that the stock of the lab was always updated to

keep projects flowing smoothly and without interruption

. Created and extracted data from source documentation

. Ensured that experimentation was protocol compliant

. Trained and supervised new technicians

Feb. 2000 to Aug. 2002 Louisiana State University Health Sciences

Center - New Orleans, LA

Clinical Research Associate-School of Public Health,

Section of Forensic Medicine

. Created and entered data into databases and

spreadsheets in Excel and Access for efficient

access to critical and confidential information

gathered from 3 research sites across the state of

Louisiana

. Reviewed medical charts to identify potential study

participants

. Performed internal audits to check for compliance with

SOPs and GCP

. Completed all data forms required by the study by

reviewing the inpatient and outpatient medical records

and creating and updating source documents

. Communicated with the physician, sponsors, sites, PI,

and nurse coordinator to ensure that the protocol is

being followed appropriately

. Assisted principal investigator in preparing reports for

the research study

. Monitored and submitted paperwork needed for study

protocols such as regulatory documents, patient

consents, protocol deviations and serious adverse events

. Acted as a liaison between patient and investigators to

ensure continued patient participation in study

. Source verified CRFs and patient forms across various

studies to ensure proper documentation and completion of

documents.

. Performed site visits to ensure they were conducting the

procedures according to the protocols

May 1999 to Aug.1999 Lee County Cooperative Clinic - Marianna, AR

Administrative Assistant-Finance Department

. Responsible for Faxing, Xeroxing, and filing documents

on a daily basis which increased the overall

productivity and efficiency of the office

. Counted large sums in daily cash revenue

. Assisted in filing Medicaid/Medicare coding and

remittance forms

. Completed daily ledger sheets which gave an accurate

account of daily revenues

. Directed a multi-line telephone system

. Communicated daily with patients, physicians, and nurses

May 1998 to Jul.1998 Lee County Cooperative Clinic - Marianna, AR

Medical/Dental Assistant

. Prepared examination room and necessary supplies needed

for doctor prior to seeing patients

. Responsible for Faxing, Xeroxing, and filing documents

on a daily basis which increased the overall

productivity and efficiency of the office

. Developed and prepared x-rays for assessment

. Prepared and completed confidential information in

patients' charts including medical billing and coding

. Intermediary between doctor and pharmacy

. Provided customer service by informing patients of

status and providing forms for employers to validate

services performed

. Directed a multi-line telephone system

. Ensured proper sterilization and maintenance of

equipment

TRAINING:

. Member of SoCRA (Society of Clinical Research

Associates)

. Member of CALGB (Cancer and Leukemia Group B)

. Member of CTSU (Clinical Trials Support Unit)

. Completion of Introductory Process for Clinical

Investigators (sponsored by FDA/NIH-Institute of Allergy

and Infectious Diseases)

. Completion of Human Studies Education course (Wash U)

. Completion of Clinical Research Training course

(sponsored by NIH)

. Completion of the Human Participants Protection

Education for Research Teams course (sponsored by NIH-

National Cancer Institute)-

. Completion of "How to Conduct Clinical Research"

training

. Trained in HIPPA (Health Insurance Portability and

Accountability Act) Compliance

. Trained in Environmental Health and Safety

. Certified to handle radiation, radiopharmaceuticals and

specifically positron emission tomography radiation

. Certificate in Pharmaceutical Clinical Trials

. Certificate in Drug Review and Related Activities in the

United States

. Certificate in FDA MedWatch and Patient Safety

. Certificate in Field Investigators: Adverse Drug Effects

Investigators

. Certificate in the FDA Process for Approving Generic

Drugs

. Trained in yearly medical billing compliance testing and

ALARA (As low as reasonably achievable)

. Trained in Shipping Dangerous and Infectious Substances

. Trained in CITI (Collaborative Institutional Training

Initiative): The Protection of Human Research Subjects

(Wash U)

. Trained in Handling, Shipping, Recognizing and

Transporting Hazardous Materials (Hazmat)

RESEARCH PROJECTS AND ABSTRACTS:

"The Isolation, Extraction, Digestion, and Electrophoresis of Peppergrass

Using the Digestive Enzymes BamI and HindIII"

Dillard University---New Orleans, LA

"ATP-induced movement of the stalks of isolated cochlear Dieters' Cell"

Louisiana State University Health Sciences Center---New Orleans, LA

Herrero P, Kisrieva-Ware Z, Dence CS, Coggan AR, Eisenbeis P,

Scott SRW, Welch MJ, Gropler RJ. "Assessment of a Mathematical Model to

Measure Myocardial Lactate Oxidation using L-3[C-11]-Lactic Acid and

Positron Emission Tomography" American Society of Nuclear Cardiology, 2005.

Herrero P, Coggan AR, Kisrieva-Ware Z, Dence CS, Eisenbeis P, Scott

SRW, Gropler RJ. "Assessment of Myocardial Fatty Acid Metabolism with 1-11C-

Palmitate and Kinetic Modeling: Testing the Limits." Society of Nuclear

Medicine, 2006.

Contact this candidate