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Cheryl A. Wagner, B.S.N.
EDUCATION
B.S., Nursing, 2005
Mount St. Mary’s College, Los Angeles, CA
THERAPEUTIC EXPERIENCE
Genitourinary: End Stage Renal Disease
Oncology: Non Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer
Women’s Health: Obstetrics/Gynecology
Infectious Disease: Influenza
PROFESSIONAL EXPERIENCE
PPD, Morrisville, NC Senior CRA Mar 2009-present
CRA II Mar 2008-Mar 2009
CRA I Aug 2006-Mar 2008
Senior CRA:
• Management and mentoring of junior CRAs reviewing trip reports, time sheets, CTMS and Cascade
review.
• Performed all aspects of in-house site management on assigned studies in accordance with GCPs
and PPD Global SOPs.
• Conducted calls with investigative sites on a regular basis to support site execution of the study
responsibilities.
• Played an active role within the clinical team to reach project goals, achieve deliverables, and meet
project deadlines:
− Managed over 60 sites.
− Communicated with study site personnel via frequent email and telephone contacts.
− Documented site issues noted during site management contacts.
− Escalated issues as directed in the study communication and monitoring guidelines.
− Assisted with the resolution of outstanding data queries.
− Ensured sites followed ICH/GCP guidelines.
− Performed file audits on the PPD investigator files.
− Communicated with study sites via dedicated study hotline.
− Communicated with study sites to ensure timely reporting of SAEs.
− Communicated with study sites to ensure regulatory document completion and submission.
− Completed close-out activities via phone.
• Documented site issues and follow up activities in phone contact reports and emails in a timely
manner using approved business writing standards.
• Escalated observed deficiencies and issues to management expeditiously and followed all issues to
resolution.
Cheryl A. Wagner, B.S.N. Page 2 of 4
• Maintained regular contacts with investigative sites to confirm that the protocol was being followed,
that previously identified issues were being resolved and that the data was being recorded in a timely
manner.
• Performed and coordinated rapid study start-up, interim and closeout activities to ensure applicable
timelines and metrics were met in accordance with GCPs, ICH Guidelines and PPD Global SOPs.
• Performed review and transmission of regulatory documents.
• Implemented project plans with specific guidelines for meeting project timelines.
• Managed study data including the review and tracking of study documents to ensure completeness
and accuracy.
• Managed essential documents, as required by local regulations and ICH GCP guidelines.
• Maintained clinical trial management systems effectively in order to ensure adequate communication
to project team and sponsor.
• Trained and mentored new team members.
• Contributed to the project by assisting in the preparation of project publication/tools and sharing
ideas/suggestions with team members.
CRA II:
• Performed and coordinated rapid study start-up, interim and closeout activities to ensure applicable
timelines and metrics were met in accordance with FDA GCPs, ICH Guidelines and PPD Global
SOPs.
• Performed review and transmission of regulatory documents.
• Initiated negotiation of clinical study agreements, budgets and investigator grants.
• Implemented project plans with specific guidelines for meeting project timelines.
• Performed file audits on the PPD investigator files.
• Managed study data including the review and tracking of study documents to ensure completeness
and accuracy.
• Managed essential documents, as required by local regulations and ICH GCP guidelines.
• Maintained clinical trial management systems effectively in order to ensure adequate communication
to project team and sponsor.
• Trained and mentored new team members.
• Contributed to the project by assisting in the preparation of project publication/tools and sharing
ideas/suggestions with team members.
CRA I:
• Performed and coordinated rapid study start-up, interim and closeout activities to ensure applicable
timelines and metrics were met in accordance with FDA GCPs, ICH Guidelines and Global PPD
SOPs.
• Performed review and transmission of regulatory documents.
• Initiated negotiation of clinical study agreements, budgets and investigator grants.
• Implemented project plans with specific guidelines for meeting project timelines.
• Ensured accuracy of investigator files and prepare for audit readiness.
• Performed file audits on the PPD investigator files.
• Managed study data including the review and tracking of study documents to ensure completeness
and accuracy.
• Managed essential documents, as required by local regulations and ICH GCP guidelines.
• Maintained clinical trial management systems effectively in order to ensure adequate communication
to project team and sponsor.
• Trained and mentored new team members.
• Contributed to the project by assisting in the preparation of project publication/tools and sharing
ideas/suggestions with team members.
Printed: 03/31/15 Revised: 2/27/15
Cheryl A. Wagner, B.S.N. Page 3 of 4
United States Air Force Reserves, NC Nurse, Captain 2012-Current
• Officer in charge (OIC) of Immunizations ensuring the 1500 Reserve members are mobility ready.
• Supervise 6 individuals ensuring qualifications and training are accomplished and current.
• Provided emergency nursing care to residents of Seymour Johnson Air Force Base.
• Prepared medically for war-time disasters and supervising fellow members.
Duke University Hospital, Durham, NC Clinical II Dialysis Nurse 2005-2006
• Performed routine and emergent Dialysis (and general patient care) for acute and chronic Dialysis
patients.
• Coordinated with primary team, as well as renal team to provide optimal care for patients.
• Carried out the role of Charge Nurse weekly ensuring the overall patient care quality.
United States Air Force Reserves, MD Nurse, 2Lt 2005-2007
• Provided nursing care to residents of Andrews Air Force Base including physical exams and
immunizations.
• Prepared medically for war-time disasters and supervising fellow members.
Cedar-Sinai Hospital, CA ED Assistant 2002-2003
• Assisted patients, family during Emergency Department stay.
• Coordinated with members of trauma team during critical emergencies.
• Assisted physicians and nurses with lab work, radiology requests, triage, and documentation.
LA Weight Loss, FL Nutrition Counselor 2001-2002
• Provided nutritional and dietary counseling to clients, render them emotional support during their
programs.
• Prepared clients’ medical history.
• Performed blood draws and vital signs.
• Implemented administrative tasks including, answering calls, preparation of medical records and
reports.
United States Air Force Reserves, FL, CA, NC EMT, Med tech 2000-2006
• Participated at monthly refresher training sessions, keeping current on EMT/medical technician skills.
• Provided patient care in Reserve clinics (including ECGs, immunizations, phlebotomy, assisted
physicians with physical exams).
United States Air Force (Active Duty), SD EMT, Med tech 1997-2000
• Worked with the Ambulance Service: Providing emergency care, performing blood alcohol tests, and
administrative tasks.
Printed: 03/31/15 Revised: 2/27/15
Cheryl A. Wagner, B.S.N. Page 4 of 4
• OB/GYN Clinic: Assisted four physicians by administering patient care including screening
procedures (STD’s), women’s health, administering medications, injections, and assisting with pap
smears, wet preps, incontinence testing and urinalysis testing of pregnant patients.
• Same Day Surgery Unit: Assisted patients with care pre-and post-surgery, performed wound care,
mobility and IVs.
LICENSES & CERTIFICATIONS
• State of North Carolina Registered Nursing License since 2005
• Nationally Certified Emergency Medical Technician since 1997
• American Heart Association BLS for Healthcare Providers since 1997
• Advanced Cardiac Life Support License, 2007
PROFESSIONAL DEVELOPMENT
Training while employed at PPD is available upon request.
COMPUTER EXPERIENCE
Windows 95-98, Windows XP, MS Word, Word Perfect, Excel, MS Word, Internet, Netscape, CASCADE
(CTMS), PowerPoint, Clintrack, Outlook, Inform 5.5, Rave, EDC, RightFax.
CLINICAL TRIAL EXPERIENCE
Clinical trial experience while employed at PPD:
• Oncology: An Observational Study Of XXXX (XXXX) In Combination With Chemotherapy For
Treatment Of Metastatic Of Locally Advanced And Unresectable Colorectal Cancer, Locally
Advanced Of Metastatic Non−Small Cell Lung (Excluding Predominate Squamaous Cell Histology).
• Oncology: An Observational Study Of Treatment Patterns and Safety Outcomes for Metastatic
Or Locally Recurrent Breast Cancer.
• Infectious Disease: A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated
Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age.
• Oncology: An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with
HER2 Positive (HER2+) Metastatic Breast Cancer.
Printed: 03/31/15 Revised: 2/27/15

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Wagner_Cheryl

  • 1. Cheryl A. Wagner, B.S.N. EDUCATION B.S., Nursing, 2005 Mount St. Mary’s College, Los Angeles, CA THERAPEUTIC EXPERIENCE Genitourinary: End Stage Renal Disease Oncology: Non Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer Women’s Health: Obstetrics/Gynecology Infectious Disease: Influenza PROFESSIONAL EXPERIENCE PPD, Morrisville, NC Senior CRA Mar 2009-present CRA II Mar 2008-Mar 2009 CRA I Aug 2006-Mar 2008 Senior CRA: • Management and mentoring of junior CRAs reviewing trip reports, time sheets, CTMS and Cascade review. • Performed all aspects of in-house site management on assigned studies in accordance with GCPs and PPD Global SOPs. • Conducted calls with investigative sites on a regular basis to support site execution of the study responsibilities. • Played an active role within the clinical team to reach project goals, achieve deliverables, and meet project deadlines: − Managed over 60 sites. − Communicated with study site personnel via frequent email and telephone contacts. − Documented site issues noted during site management contacts. − Escalated issues as directed in the study communication and monitoring guidelines. − Assisted with the resolution of outstanding data queries. − Ensured sites followed ICH/GCP guidelines. − Performed file audits on the PPD investigator files. − Communicated with study sites via dedicated study hotline. − Communicated with study sites to ensure timely reporting of SAEs. − Communicated with study sites to ensure regulatory document completion and submission. − Completed close-out activities via phone. • Documented site issues and follow up activities in phone contact reports and emails in a timely manner using approved business writing standards. • Escalated observed deficiencies and issues to management expeditiously and followed all issues to resolution.
  • 2. Cheryl A. Wagner, B.S.N. Page 2 of 4 • Maintained regular contacts with investigative sites to confirm that the protocol was being followed, that previously identified issues were being resolved and that the data was being recorded in a timely manner. • Performed and coordinated rapid study start-up, interim and closeout activities to ensure applicable timelines and metrics were met in accordance with GCPs, ICH Guidelines and PPD Global SOPs. • Performed review and transmission of regulatory documents. • Implemented project plans with specific guidelines for meeting project timelines. • Managed study data including the review and tracking of study documents to ensure completeness and accuracy. • Managed essential documents, as required by local regulations and ICH GCP guidelines. • Maintained clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor. • Trained and mentored new team members. • Contributed to the project by assisting in the preparation of project publication/tools and sharing ideas/suggestions with team members. CRA II: • Performed and coordinated rapid study start-up, interim and closeout activities to ensure applicable timelines and metrics were met in accordance with FDA GCPs, ICH Guidelines and PPD Global SOPs. • Performed review and transmission of regulatory documents. • Initiated negotiation of clinical study agreements, budgets and investigator grants. • Implemented project plans with specific guidelines for meeting project timelines. • Performed file audits on the PPD investigator files. • Managed study data including the review and tracking of study documents to ensure completeness and accuracy. • Managed essential documents, as required by local regulations and ICH GCP guidelines. • Maintained clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor. • Trained and mentored new team members. • Contributed to the project by assisting in the preparation of project publication/tools and sharing ideas/suggestions with team members. CRA I: • Performed and coordinated rapid study start-up, interim and closeout activities to ensure applicable timelines and metrics were met in accordance with FDA GCPs, ICH Guidelines and Global PPD SOPs. • Performed review and transmission of regulatory documents. • Initiated negotiation of clinical study agreements, budgets and investigator grants. • Implemented project plans with specific guidelines for meeting project timelines. • Ensured accuracy of investigator files and prepare for audit readiness. • Performed file audits on the PPD investigator files. • Managed study data including the review and tracking of study documents to ensure completeness and accuracy. • Managed essential documents, as required by local regulations and ICH GCP guidelines. • Maintained clinical trial management systems effectively in order to ensure adequate communication to project team and sponsor. • Trained and mentored new team members. • Contributed to the project by assisting in the preparation of project publication/tools and sharing ideas/suggestions with team members. Printed: 03/31/15 Revised: 2/27/15
  • 3. Cheryl A. Wagner, B.S.N. Page 3 of 4 United States Air Force Reserves, NC Nurse, Captain 2012-Current • Officer in charge (OIC) of Immunizations ensuring the 1500 Reserve members are mobility ready. • Supervise 6 individuals ensuring qualifications and training are accomplished and current. • Provided emergency nursing care to residents of Seymour Johnson Air Force Base. • Prepared medically for war-time disasters and supervising fellow members. Duke University Hospital, Durham, NC Clinical II Dialysis Nurse 2005-2006 • Performed routine and emergent Dialysis (and general patient care) for acute and chronic Dialysis patients. • Coordinated with primary team, as well as renal team to provide optimal care for patients. • Carried out the role of Charge Nurse weekly ensuring the overall patient care quality. United States Air Force Reserves, MD Nurse, 2Lt 2005-2007 • Provided nursing care to residents of Andrews Air Force Base including physical exams and immunizations. • Prepared medically for war-time disasters and supervising fellow members. Cedar-Sinai Hospital, CA ED Assistant 2002-2003 • Assisted patients, family during Emergency Department stay. • Coordinated with members of trauma team during critical emergencies. • Assisted physicians and nurses with lab work, radiology requests, triage, and documentation. LA Weight Loss, FL Nutrition Counselor 2001-2002 • Provided nutritional and dietary counseling to clients, render them emotional support during their programs. • Prepared clients’ medical history. • Performed blood draws and vital signs. • Implemented administrative tasks including, answering calls, preparation of medical records and reports. United States Air Force Reserves, FL, CA, NC EMT, Med tech 2000-2006 • Participated at monthly refresher training sessions, keeping current on EMT/medical technician skills. • Provided patient care in Reserve clinics (including ECGs, immunizations, phlebotomy, assisted physicians with physical exams). United States Air Force (Active Duty), SD EMT, Med tech 1997-2000 • Worked with the Ambulance Service: Providing emergency care, performing blood alcohol tests, and administrative tasks. Printed: 03/31/15 Revised: 2/27/15
  • 4. Cheryl A. Wagner, B.S.N. Page 4 of 4 • OB/GYN Clinic: Assisted four physicians by administering patient care including screening procedures (STD’s), women’s health, administering medications, injections, and assisting with pap smears, wet preps, incontinence testing and urinalysis testing of pregnant patients. • Same Day Surgery Unit: Assisted patients with care pre-and post-surgery, performed wound care, mobility and IVs. LICENSES & CERTIFICATIONS • State of North Carolina Registered Nursing License since 2005 • Nationally Certified Emergency Medical Technician since 1997 • American Heart Association BLS for Healthcare Providers since 1997 • Advanced Cardiac Life Support License, 2007 PROFESSIONAL DEVELOPMENT Training while employed at PPD is available upon request. COMPUTER EXPERIENCE Windows 95-98, Windows XP, MS Word, Word Perfect, Excel, MS Word, Internet, Netscape, CASCADE (CTMS), PowerPoint, Clintrack, Outlook, Inform 5.5, Rave, EDC, RightFax. CLINICAL TRIAL EXPERIENCE Clinical trial experience while employed at PPD: • Oncology: An Observational Study Of XXXX (XXXX) In Combination With Chemotherapy For Treatment Of Metastatic Of Locally Advanced And Unresectable Colorectal Cancer, Locally Advanced Of Metastatic Non−Small Cell Lung (Excluding Predominate Squamaous Cell Histology). • Oncology: An Observational Study Of Treatment Patterns and Safety Outcomes for Metastatic Or Locally Recurrent Breast Cancer. • Infectious Disease: A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age. • Oncology: An Observational Cohort Study of Treatment Patterns and Outcomes in Patients with HER2 Positive (HER2+) Metastatic Breast Cancer. Printed: 03/31/15 Revised: 2/27/15