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KAYLA CLAYTON 1302 Santa Fe Pkwy, Sandy Springs GA 30350 | ckayclayt@aol.com | 678.973.7462

SUMMARY OF

QUALIFICATIONS

Over four years of rigorous project management experience involving high-level, complex clinical trial

management and over 6 years of clinical research experience.

Exemplifies the highest standards of professional integrity, leadership, and problem-solving.

Mitigates risk to urgent client deliverables such as a clinical study launch by facilitating communication

and assembling resources across various departments.

Successfully launched trial during senior team members’ absence, loading over 90 sites and providing

over 1,000 kits to sites throughout the U.S. and Canada within 72 hours.

Reconciled over 1200 patient data discrepancies within two days, leading to a successful data transfer and

closure of the clinical trial.

EXPERTISE

Microsoft Office Suite, including Microsoft Project, Word, Lotus Notes, and Advanced Excel Applications.

Windows, Linux and Mac platforms, hardware and software repair and installation.

Basic knowledge of SPSS, Matlab, and Python and C++ programming languages.

Clinical Research and FDA regulations

ICH-GCP Certification.

EDUCATION UNIVERSITY OF ROCHESTER, ROCHESTER, NY

BRAIN & COGNITIVE NEUROSCIENCE, BS

MISSISSIPPI SCHOOL FOR MATHEMATICS & SCIENCE, COLUMBUS, MS

HIGH SCHOOL DIPLOMA

EXPERIENCE REGIONAL PROJECT MANAGER/ SR PROJECT COORDINATOR–QUINTILES

12/2013-PRESENT.

Effectively assists with management of various large-scaled, global pharmaceutical Phase I-IV trials from

study startup to study closure consisting of over 15,000 research sites worldwide. Pharmacological

indications include Parkinson’s disease, oncology, diabetes, epilepsy, and keratoconjunctivitis.

Monitors over 30 global clinical research trials for major pharmaceutical sponsors. Monitoring ensures that

sites receive necessary clinical supplies, safety reports, and assistance with specimen collection.

Leads clinical calls for study updates and compiles meeting minutes.

Oversees modification to clinical database programming per client change requests.

Mitigates risk to urgent client deliverables such as a clinical study launch by facilitating communication and

assembling resources across various departments.

Conducts remote site and investigator trainings via WebEx.

Troubleshoots application issues via research, information gathering, and cross collaboration with IT and

clinical laboratories.

Manages clinical project coordinators and acts as a liaison between clinical sites, CRAs, and sponsors.

Provides consultation to clinical research sites, ensuring adherence to ICH-GCP compliance as well as

sponsor standards, FDA regulation, and general standard operating procedures.

Creates and provides carefully constructed and detailed Microsoft Excel reports of clinical trial information

to ensure timely progression of clinical trial deadlines.

Oversees study budgets to ensure that material wastage is reduced, and forecasts potential concerns to

mitigate financial risks.

Develops and compiles lab manuals based on region specific protocols.

Compiles data reconciliations for large scale trials and routinely cleans data for regular data transfers.

Maintains electronic documentation and records for clinical audit purposes, providing support and/or

actively participating in audits and regulatory meetings

Provides mentorship and assists with the professional development of new hires.

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EXPERIENCE |

PROJECT COORDINATOR/ SET-UP SPECIALIST- QUINTILES 08/2012-12/2013

Provided assistance with pre-launch clinical database support, including the design and validation of

sponsor’s clinical database and research protocol according to study requirements.

Ensured timely arrival of kits supplies to research sites and resolution of open data clarifications.

Performed post-study launch modifications and background programming via proprietary laboratory

management systems and Microsoft Lotus Notes.

Performed clinical research monitoring, ensuring compliance with study protocol specifications

Configured global programming of multi-regional, simultaneous complex pharmaceutical trials for

sponsors, ensuring that all clinical test programming is accurate per trial specifications.

EDUCATIONAL CONSULTANT- TUTOR DOCTOR 03/2013-PRESENT

Observes, instructs, and mentors up to 10 students per week in areas that are in need of improvement while

providing encouragement and positive feedback.

Provides homework assistance and aid for standardized test preparation.

Designs assessments to monitor students’ progress throughout tutoring course, ensuring that the program

translates into classroom success.

Assists with the creation, development, and launch of learning programs and providing tutors with

instructional training.

QUALITY ASSURANCE PROOFER- PRIUM MEDICAL COST MANAGEMENT 03/2012-08/2012

Provided interpretation of medical findings and patient case documents for clinical review.

Reviewed and proofread documents to ensure all necessary quality standards are met.

Issued recommendation for medical treatment while ensuring adequate patient care and cost effectiveness.

AT&T BUSINESS CARE REPRESENTATIVE- ALORICA CALL CENTER 11/2011-03/2012

Provided assistance to customers concerning billing inquiries, device troubleshooting, and networking

issues.

Used the integration of multiple systems to effectively research and notate customer accounts and ensure

accurate customer information.

Transcribed of calls in real-time while providing technical troubleshooting support to resolve hardware,

software, and user error discrepancies.

RESEARCH ASSISTANT, DEPT. OF IMMUNOBIOLOGY & STRESS RESPONSE- URMC 12/2009-06/2011

Performed biological assay analysis and buffer preparation.

Ensured experiment quality control via equipment sterilization and machinery calibration.

Performed flow cytometry and cellular analysis.

Maintained national database of subject information and experimental data.

Supplied data calculations and data analysis of experimental results.

STUDENT RESEARCHER, PERCEPTION AND ACTION LAB- UNIVERSITY OF ROCHESTER 01/2010-05/2010

Graded independent research course in which students conducted an independent, novel experiment of

their own design on a topic within the field of cognitive neuroscience.

Required to recruit subjects, to construct a novel experiment with very few potential confounds, to conduct

extensive literature research and peer review, and to critically analyze and interpret experimental findings.

Studies involved working directly with human subjects, constructing experimental designs, and

investigating techniques used in cognitive neuroscience such as eye-tracking, TMS, EEG, etc.

MEDICAL TRANSCRIPTIONIST, DEPT. OF ORTHOPEDICS- URMC 01/2007-05/2007

Upheld the upmost standards of patient confidentiality due to my duties of maintaining accurate patient

information for physician visits, transcribing medical records to a computer database, and follow-up

scheduling.

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