Project Manager
Resume:
Shalonda R. W. Scott
St. Louis, MO 63146
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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