Project Manager Management
Resume:
Kelley Atkinson, MPA
Raleigh, North Carolina 27616
Phone :919-***-****
Email :******.********@*******.***
Summary of Qualifications
Professional Experience
• Clinical Research, Phases I IV
o Clinical Monitoring – 8.5 years
o Clinical trials assistant – 2.5 years
Therapeutic Experience
• Cardiovascular:
Congestive Heart Failure, Acute Ischemic Heart Disease
• CNS:
Neurology – Alzheimer’s disease, Multiple Sclerosis, Parkinson’s disease
Psychiatry ADHD, Depression, General Anxiety, Insomnia
• Endocrine:
Osteoporosis, Diabetes drug and device
• GI:
Ulcerative colitis
• Immune Deficiency:
Immune Tolereance Induction Therapy, Hereditary Angioedema (HAE)
• Psychiatry:
Addiction
o Opioid Dependency
• Dermatology:
o Psoriasis
o Chronic hand eczema
Professional Experience
BioCryst
(contractor with Inventiv)
Study Manager
CV for Kelley Atkinson
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Kelley Atkinson, MPA
3314 Landing Falls Lane
Raleigh, North Carolina 27616
Phone :919-***-****
Email :******.********@*******.***
July 2013 – Present
• Assists in the development of clinical trials including the development of the overall clinical plan, protocols,
informed consent documents, case report forms (CRFs), CRF guidelines, statistical and pharmacokinetic
analysis plans, and data management plans including edit check specifications.
• Assists with the development and implementation of study specific monitoring plan, study tools including
communication plan, investigator grants, study budget, study timelines, and subject and study tracking
systems.
• Assists in identifying overall resourcing needs for assigned projects, including interal and external outsourced
services (i.e., contract research organizations (CROs), central laboratories, contractors, in house CRAs, etc.);
coordinates the request for proposal process including negotiation of budget, defining expectations and
deliverables; assesses qualifications and experience, and participates in final selection.
• Advises and trains CRO personnel on project related educational needs.
• Participates in the development of site qualification criteria and in the identification of potential investigators
and clinical sites; oversees and participates (as needed) in prestudy site visits, reviews evaluative reports;
participates in the final selection of study sites.
• Assesses study drug requirements and shipment logistics.
• Oversees the site approval process with respect to critical document requirements, Institutional Review Board
(IRB) approvals, IRB questions, site informed consent review, and review of contracts, in conjunction with
relevant internal departments (as necessary).
• Oversees and participates (as needed) in initiation visits, review of reports and follow up to identify and resolve
site issues.
Oversees and participates in Investigator Meetings.
•
Oversees the day to day activities of the clinical trial and associated resources (CROs, CRAs centralized
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laboratories, etc).
Identifies and evaluates issues related to the project and coordinates resolutions.
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Oversees and participates (as needed) in site monitoring visits, review of reports and follow up to identify and
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resolve site issues.
Ensures appropriate transmission of CRF data to data management team and reviews queries.
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Identifies data deficiencies and discrepancies, and coordinates corrective action as required.
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Assists in the site audit process and coordinates the audit responses to ensure conformance to industry and
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company standards.
Oversees and participates (as needed) in site close out visits, review of reports and follow up to identify and
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resolve final site issues.
Assists in the review and approval process of Tables, Listings and Graphs.
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CV for Kelley Atkinson
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Kelley Atkinson, MPA
3314 Landing Falls Lane
Raleigh, North Carolina 27616
Phone :919-***-****
Email :******.********@*******.***
Coordinates CSR writing, review and approval process including the compilation of all required sections.
•
Stiefel
(contractor with Novella Clinical)
Lead Clinical Research Associate
February 2013 – July 2013
• Managed direct reports during a regulatory project in preparation for regulatory submission to the authorities.
• Evaluated project progress escalating issues to the Study Manager
• Performed site selection, initiation, monitoring and close out visits in accordance with contracted scope of work
and good clinical practice.
• Created and maintain appropriate documentation regarding site management, monitoring visit findings and
action plans by submitting timely visit reports.
• Provided assistance to the Study Manager with design of study tools, documents and processes.
Quintiles
Sr. Clinical Research Associate III
August 2012 – February 2013
• Performed site selection, initiation, monitoring and close out visits in accordance with contracted scope of work
and good clinical practice.
• Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
• Administered protocol and related study training to assigned sites and establish regular lines of communication
with sites to manage ongoing project expectations and issues.
• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and
adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager.
• Managed 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.
• Created and maintain appropriate documentation regarding site management, monitoring visit findings and
action plans by submitting regular visit reports and other required study documentation.
• Provided assistance to the CTL with design of study tools, documents and processes.
• Assisted with managing the project scope of work, objectives, deliverables, financials and work orders.
INC Research
In House Clinical Research Associate
August 2008 – August 2012
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Kelley Atkinson, MPA
3314 Landing Falls Lane
Raleigh, North Carolina 27616
Phone :919-***-****
Email :******.********@*******.***
• Site management activities included all in house and on site monitoring for all visit types.
• Provided training to project teams on protocol, CRF completion, sponsor SOPs, clinical plans and guidelines
and study timelines.
• Lead weekly project calls with CRAs.
• Assisted management in the quarterly evaluation of and feedback on team members’ individual job
performance.
• Assisted with managing the project scope of work, objectives, deliverables, financials and work orders.
• Identified and Qualified study sites in collaboration with Project Manager.
• Ensured all assigned sites are trained on the study protocol, informed consent process, data collection
requirements/data collection tools (e.g., EDC systems, IVR systems, etc.), SAE reporting requirements and
patient reported outcomes instruments, as applicable.
• Lead the development of the site management plan in collaboration with Project Manager for assigned studies.
• Mentored less experienced staff.
• Monitored site performance metrics and implements action plans for sites not meeting expectations.
• Provided project management team with timely updates regarding site management and/or performance issues.
Novartis Pharmaceuticals
(contractor with Ingenix i3Pharma)
Regional Clinical Research Associate
October 2006 – April 2008
• Lead CRA duties included: preparing monitoring tools and monitoring plans, training CRAs, and Investigator
Meeting presentations.
• Ensured investigators and site staff conducted study per protocol and in accordance with regulatory authority
guidelines (FDA, ICH/GCP, etc.).
• Conducted routine monitoring and site management activities at multiple study centers.
• Identified potential study sites and performed site selection visits.
• Performed initiation, monitoring, and close out activities at selected clinical investigative sites.
• Trained site staff on protocols and study procedures.
• Reviewed paper Case Report Forms and electronic data (EDC) to identify erroneous, missing, incomplete, or
implausible data.
• Ensured data quality of managed sites resulting in low query rates.
PAREXEL International
Regional Clinical Research Associate I and II
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Kelley Atkinson, MPA
3314 Landing Falls Lane
Raleigh, North Carolina 27616
Phone :919-***-****
Email :******.********@*******.***
June 2004 – September 2006
• Conducted routine monitoring and site management activities at multiple study centers.
• Performed initiation, monitoring, and close out activities at selected clinical investigative sites.
• Responsible for completing trip reports, follow up letters, and updating study trackers per Sponsor
requirements and CRO SOPs.
• Participated in investigator meetings.
• Trained new Clinical Research Associates.
• Reviewed trip reports.
Duke Clinical Research Institute (DCRI)
Clinical Trials Assistant II
April 2002 June 2004
• Conducted needs analysis and recommend corrective action for training and development for sites.
• Reviewed regulatory documents ensuring compliance with Good Clinical Practice (GCP) rules and regulations.
• Contacted sites to resolve study related issues and monitor progress in completing regulatory documents.
• Tracked the flow of clinical data, and ensured central files were well maintained.
• Established time schedules and prioritized study related tasks for multiple projects to achieve timeline goals.
• Performed internal audits of essential documents.
• Generated project status reports for clinical team leaders.
• Maintained knowledge of all assigned job responsibilities, GCP/ICH guidelines and their application and
company specific SOPs/Work Instructions.
• Trained members of project team and other clinical staff.
• Attended training classes and sessions to upgrade knowledge of the position, company and industry.
• Performed preliminary review, site follow up, tracking and data entry of regulatory documents.
Education
Strayer University
Raleigh, North Carolina
Masters of Public Administration, 2013
Durham Technical Community College
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Kelley Atkinson, MPA
3314 Landing Falls Lane
Raleigh, North Carolina 27616
Phone :919-***-****
Email :******.********@*******.***
Durham, North Carolina
Clinical Research Associate Certificate Level I, 2001
North Carolina Central University
Durham, North Carolina
Bachelor of Science in Chemistry, 2000
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