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Michelle O’Neal
monealbusiness@outlook.com
5324 Sapphire Springs Drive
Knightdale, NC 27545
919-930-1682 (cell)
OBJECTIVE
Goal is to obtain clinical research position with a mission-oriented, team-focused organization and
helping maintaining its competitive edge through the timely delivery of quality products and services.
PROFESSIONAL SUMMARY
Accomplished, results-oriented professional with over 25 years of medical administration and over seven
years clinical research experience with Pre-clinical, Phase I, Phase II, Phase III and Phase IV studies.
Proven success in coordinating and supporting Principle Investigators, Project Managers, and CRAs, IND
and support staff. Strong expertise in Medical Terminology, Project Management and clinical regulatory
documentation & submission processes. An energetic self-starter with strong leadership skills and
exceptional communication strengths with internal and external clients. Ability to multi-task, stay focused
and prioritize needs. Knowledgeable of the FDA requirements.
SELECTED ACCOMPLISHMENTS
 Winner of STAR Award at Quintiles, Inc. for outstanding performance.
 Winner of Customer Service Award at Quintiles, Inc. initiated by the largest Sponsor.
 Recognized by Quintiles, Inc. in two consecutive quarters for having the most central sites up and
running, and having the shortest turnaround time.
 Exceeded Quintiles local investigator sites and central investigator sites metric goals for 2007-
2008.
 Experienced with therapeutics in multiple Oncology trials, CNS/Cardiovascular, HIV, Asthma,
Gastrointestinal Disease, Macular Degeneration and Hemophilia.
PROFESSIONAL EXPERIENCE
INC Research. (12/2015 – 02/2016)
Site Start Up Specialist II (Contractor)
• Communicated regularly with Site Relations Specialists in Patient and Site Management Services
during the site identification process
• Served as a central contact for designated project reports, communications/correspondence, and
associated documentation
• Member of the “Amendment Team” specializing in Informed Consent Review for Sponsor
Approval
• Acted as central contact for investigative sites (e.g., follow up with sites for missing documents,
answer site questions, etc.) and as internal liaison consistent with customer service guidelines
• Reviewed regulatory documents, contacted sites as required to resolve issues, and determined
completeness and readiness for Clinical Supplies/Investigational Product shipments
• Interacted with regulatory team members and sponsors to secure sign-off of regulatory documents
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• Assisted designated team members with preparing submissions by compiling document for the
IEC/IRB and forwarding packages to Investigators or IEC/IRB members as directed
Rho, Inc. (05/2012 – 09/2012) Chapel Hill, NC
Lead, Clinical Trial Associate (Contractor)
• Central contact for investigative sites (e.g., follow up with sites for missing documents,
answer site questions, etc.) and as internal liaison consistent with customer service
guidelines.
• Foster positive site relationships through sufficient contact and timely provision of required
materials.
• Interacted with regulatory team members and sponsors to secure sign-off of regulatory
documents.
• Study site management including set-up and activation, creation of shared-drive folders, and
coordinate and maintain study documents and materials.
• Prepared IRB submissions and follow up
• Reviewed & prepared tracked Informed Consent language appropriate for sites in accordance
with the study protocol; negotiated budget contract language and managed CTAs.
• Support the activities of the study team lead, CRAs and Clinical Trial Manager.
• Distributed documents and study-related materials to the project master file TMF.
• Responsible for executing mass communications to study sites.
• Acted as liaison to clients on non-clinical issues.
• Maintained ClinicalTrials.gov; Edited any Protocol changes or amendments; submissions,
recruitment and approval status.
• Trained and supervised assistants to the studies
Research Triangle Institute, Health Solutions (11/2011 – February 2012)
Clinical Research Coordinator (Contractor)
• Coordinate initial study start-up and maintain communication site personnel in order to carry out
these duties.
• Co-manage projects with the project leaders, focusing primarily on contractual administration,
financial management and logistics and support.
• Work closely with technical leaders to ensure that project objectives are accomplished within the
prescribed time frame and budget by tracking/analyzing/managing contract budgets throughout
project implementation.
• Site Recruitment and Feasibility.
• Perform various project administration duties such as monitoring contract deliverables; and
managing payments with external service providers.
• Function as a secondary point of contact for research sites c/o monitor study activities including
but not limited to: Addressing site questions regarding protocol issues, subject eligibility and
study requirements along with tracking subject follow-up visit status, review CRF’s.
• Assist with distribution, collection and tracking of regulatory documents.
• Provide review of site regulatory documents and assist CRA's and sites in resolving
discrepancies.
• Maintained ClinicalTrials.gov; Edited any Protocol changes or amendments; submissions,
recruitment and approval status.
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• Conduct file reviews to assure compliance with FDA regulation, ICH guidelines and relevant
SOPs, and track clinical documents.
• Thorough knowledge of GCP and ICH guideline pertaining to clinical research.
Excellent use Microsoft Office Products including Word, Excel, and PowerPoint.
Experienced with electronic data collections (EDC) systems including electronic CRFs and
Interactive Voice Response Systems (IVRS).
• Organized and be able to work collaboratively in a team environment and independently, as
needed.
• Experience in filing essential controlled documents.
Celgene, Inc. / Abraxis (07/2010 – 05/2011) Durham, NC
Clinical Research Coordinator (Contractor)
• Support the activities of the study team lead, CRAs and Clinical Trial Manager
• Ensure tracking system (including CTMS) are maintained with accurate and current data
• Manage site activation progress (including potential sites contacted, sites recruited, PSSV and
SIV scheduling, CTA execution, IRB approval, regulatory document collection, and study
drug distribution
• Verify enrollment progress including screening, screen failures, randomizations,
discontinuations, dosing cycles, completions and deaths
• Assembly of CMC documentation for regulatory submission, Understanding and interpreted
the requirements needed for NDA and INDs for regulatory compliance and CIBs
• Prepped for responses for potential regulatory questions and overall quality summaries.
• Foster positive site relationships through sufficient contact and timely provision of required
materials
• Maintain logs of all protocol and protocol amendments per trial ensuring site document
quality
• Help manage vendor expectations, relationships and deliverables
• Maintain awareness of relevant business processes and make suggestions for improvement
• Participate in investigator meetings, monitor workshops, and study teleconferences and
meetings
• Maintained ClinicalTrials.gov; Edited any Protocol changes or amendments; submissions,
recruitment and approval status.
• Assist with data clarification form resolutions for trip reports; reviewed CRFs for
completeness and accuracy.
• Prepped investigational sites for close out visits
• Tracked SAEs and logged trip reports
Quintiles, Inc. (10/2006 – 08/2008) Durham, NC
Site Start-Up Associate Specialist
• Communicated regularly with Site Relations Specialists in Patient and Site Management
Services during the site identification process
• Served as a central contact for designated project reports, communications/correspondence,
and associated documentation
• Acted as central contact for investigative sites (e.g., follow up with sites for missing
documents, answer site questions, etc.) and as internal liaison consistent with customer
service guidelines
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• Reviewed regulatory documents, contacted sites as required to resolve issues, and determined
completeness and readiness for Clinical Supplies/Investigational Product shipments
• Interacted with regulatory team members and sponsors to secure sign-off of regulatory
documents
• Assisted designated team members with preparing submissions by compiling document for the
IEC/IRB and forwarding packages to Investigators or IEC/IRB members as directed
PPD, Inc. (06/2006 – 09/2006) Morrisville, NC
Project Assistant – Patient Recruitment Services
• Provided routine project management support to Asst. Project Managers
• Assisted with the development and review of patient recruitment materials.
• Study site management including set-up and activation, creation of shared-drive folders, and
coordinate and maintain study documents and materials
• Designed and analyzed pre- and post-study site surveys.
• Managed vendor fulfillment relationships
• Distributed documents and study-related materials to the project master file MAP
• Responsible for executing mass communications to study sites.
• Acted as liaison to clients on non-clinical issues.
The Copernicus Group, IRB Services (01/2006 – 03/2006) Cary, NC
Project Specialist – New PI Submissions
• Reviewed and processed New PI Submissions for IRB Approvals.
• Researched PI medical licenses, analyzed FDA audit findings from 483’s and EIR Reports.
• Prepared documentation for Full Board Review and provided protocol tracking of document
such as Waivers of Authorization and Investigator Site Questionnaires
• Approved advertising, radio, TV and phone screening scripts recommending modifications to
proposed scripts and ads as needed
• Prepared special requests for IC Translations. paraphrase narratives for SAEs, protocol
deviations and IND safety reports for entry into an Access database
• Attended IRB Board Meetings
Charles River Laboratories, Clinical Services (11/2004 – 01/2006) Cary, NC
Project Team Assistant II / Client Support Administrator– Project Management
• Prioritized, resolved and disseminated inquiries from clients, sites, and potential subjects
• Provided assistance to the Project Manager and created weekly meeting minutes
• Handled special requests made by the Sponsor, CROs and Principle Investigators
• Knowledgeable of SOPs, Regulatory, SAE Protocols
• Conducted secondary review on regulatory documents; eClinical Tracking, Coordinated and
distributed study materials; Reviewed SAEs and IND Safety Reports, prepared document
coding and made investigator payments; Reviewed site revised ICs
• CRF Tracking, managed clinical trial study documents and prepared mail merges
• Conducted Quality of Life Trials
Wake-Med Faculty Physicians (08/2003-06/2004) Raleigh, NC
Financial Consultant - Patient Financial Services
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• Analyzed patient accounts, prepared budget plans, prepared itemized statements, and
documented patient complaints.
• Achieved highest productivity status for four consecutive periods.
• Obtained & verified insurance data, coded and filed insurance claims, assisted patient billing
department and review financial applications.
• Maintained HIPPA Protocol Regulations.
UNC Healthlink (10/2001 – 04/2004) Chapel Hill, NC
Call Center Representative - Physician Advice Line
• Responsible for after hour calls from more than 80 NC medical practices
• Patient data entry, communicated with EMS dispatch
• Prioritized complaints; liaison for nurses and On-Call physicians
• Maintained call queue by preparing Master On-Call schedule for physicians
Durham Regional Hospital (11/1993 – 02/2001) Durham, NC
Clinical Service Coordinator - Patient Financial Services,
• PT Emergency Room administrative assistant & EKG Technician
• Trained of new people for ER registration, admissions and customer service
• Scheduled outpatient procedures, collected co-payments, explained insurance benefits and
admissions to patients
• Knowledgeable of Medicare & Medicaid Regulations, and Carolina Access Approval
• Maintained Death Log Book and typed death certificates. Worked closely with the house
supervisor
EDUCATION
Hardbarger Business College, Raleigh, NC (A.A.S. Medical Secretarial Science, 1981)
Dean’s List
SOFTWARE SKILLS/TRAINING
Phase Forward; Trial Works, UAT, SMS, MS Word, Excel, Outlook, Access, PowerPoint,
Trained EKG technician, Project, MARS Network, AS400; SIMS, Mysis, IDX; Blue E; eClinical,
Lotus Notes, Intralinks Right Fax, ICON IVRS, AGMedNet, Keystroke 8000, Clintrak, Notary
Public, Linked In, CTMS
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• Analyzed patient accounts, prepared budget plans, prepared itemized statements, and
documented patient complaints.
• Achieved highest productivity status for four consecutive periods.
• Obtained & verified insurance data, coded and filed insurance claims, assisted patient billing
department and review financial applications.
• Maintained HIPPA Protocol Regulations.
UNC Healthlink (10/2001 – 04/2004) Chapel Hill, NC
Call Center Representative - Physician Advice Line
• Responsible for after hour calls from more than 80 NC medical practices
• Patient data entry, communicated with EMS dispatch
• Prioritized complaints; liaison for nurses and On-Call physicians
• Maintained call queue by preparing Master On-Call schedule for physicians
Durham Regional Hospital (11/1993 – 02/2001) Durham, NC
Clinical Service Coordinator - Patient Financial Services,
• PT Emergency Room administrative assistant & EKG Technician
• Trained of new people for ER registration, admissions and customer service
• Scheduled outpatient procedures, collected co-payments, explained insurance benefits and
admissions to patients
• Knowledgeable of Medicare & Medicaid Regulations, and Carolina Access Approval
• Maintained Death Log Book and typed death certificates. Worked closely with the house
supervisor
EDUCATION
Hardbarger Business College, Raleigh, NC (A.A.S. Medical Secretarial Science, 1981)
Dean’s List
SOFTWARE SKILLS/TRAINING
Phase Forward; Trial Works, UAT, SMS, MS Word, Excel, Outlook, Access, PowerPoint,
Trained EKG technician, Project, MARS Network, AS400; SIMS, Mysis, IDX; Blue E; eClinical,
Lotus Notes, Intralinks Right Fax, ICON IVRS, AGMedNet, Keystroke 8000, Clintrak, Notary
Public, Linked In, CTMS
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