1. Revised 07/2016
Debra Johnson, BS, CCRC, LPN
North Port, Florida
Senior Clinical Research Associate
(941) 822-9661
Office: (941) 423-4017
EDUCATION University of Phoenix, Phoenix, AZ
Bachelors of Science, Health Administration, 2013
University of Phoenix, Phoenix, AZ
Associate of Arts, 2012
Manatee Community College, Venice, FL
Licensed Practical Nurse, 1996
WORK
EXPERIENCE
Jul 2016- Present Harvard Clinical Research Institute, Boston, MA
Senior Field Monitor
• Adhere with corporate internal polices and requirements, including
submission of timesheets and expense reports in a timely manner.
• Knowledge of applicable SOPs, guidelines and study procedures.
• Assist with protocol and CRF review.
• Develop informed consent forms.
• Conduct study feasibility and site selection activities.
• Assist with the development of study manuals, annotated CRFs,
monitoring conventions, tracking forms, site study tools, and other
study materials.
• Develop and implement innovative approaches for and participates in
site recruitment, selection and initiation activities.
• Assist with investigator meeting activities including organization,
preparation and attendance.
• Conduct site management activities, including but not limited to site
qualification visits, site initiation visits, site training, site interim
monitoring visits, and site close out visits.
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2. Revised 07/2016
Feb 2016 -Jul 2016
Dec2015-Feb 2016
PRA International assigned to Merck, Bluebell, PA
Senior Clinical Research Associate
• Adhere with corporate internal polices and requirements, including
submission of timesheets and expense reports in a timely manner.
• Knowledge of applicable SOPs, guidelines and study procedures.
• Assist with protocol and CRF review.
• Develop informed consent forms.
• Conduct study feasibility and site selection activities.
• Assist with the development of study manuals, annotated CRFs,
monitoring conventions, tracking forms, site study tools, and other
study materials.
• Develop and implement innovative approaches for and participates in
site recruitment, selection and initiation activities.
• Assist with investigator meeting activities including organization,
preparation and attendance.
• Conduct site management activities, including but not limited to site
qualification visits, site initiation visits, site training, site interim
monitoring visits, and site close out visits.
Intercoastal Medical Group, Sarasota, Fl
Certified Clinical Research Coordinator (since 1998)
• Assist hospitals to implement IRB/Ethic Committee internal systems
to support clinical research
• Perform all aspects of study coordination including phlebotomy and
lab processing from study start-up through close-out for both
inpatient and outpatient studies while adhering to ICG/GCP
Guidelines
• Data Entry in electronic data capture systems
• Manage IWRS for individual studies
• Maintain and update Regulatory Documents
• Conducted in-services for hospital staff prior to implementing clinical
studies
• Reason left position: Return to corporate position
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3. Revised 07/2016
Jun 2014 to Dec
2015
Inventiv Clinical Health, Inc, Charlotte, North Carolina
Dedicated to Novo Nordisk (Contract/FSP)
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and Sponsor project
management team
• Performed lead CRA responsibilities on assigned projects
• Review of subject Diaries and Questionnaires (electronic and paper)
Reason for leaving: Family emergency. On FMLA due to death in
immediate family (son).
MAR 2014 to JUN
2014
Research Pharmaceutical Services, Inc. (Contract)
Senior Site Manager
• Adhere with corporate internal polices and requirements, including
submission of timesheets and expense reports in a timely manner.
• Knowledge of applicable SOPs, guidelines and study procedures.
• Assist with protocol and CRF review.
• Develop informed consent forms.
• Conduct study feasibility and site selection activities.
• Assist with the development of study manuals, annotated CRFs,
monitoring conventions, tracking forms, site study tools, and other
study materials.
• Develop and implement innovative approaches for and participates in
site recruitment, selection and initiation activities.
• Assist with investigator meeting activities including organization,
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4. Revised 07/2016
preparation and attendance.
• Conduct site management activities, including but not limited to site
qualification visits, site initiation visits, site training, site interim
monitoring visits, and site close out visits.
• Perform co-monitoring visits and performance assessment visits,
when properly trained and delegated by Clinical Research Manager
• Ensure the integrity of clinical data and adherence to applicable
regulatory, protocol, and company guidelines.
• Establish and maintain good rapport with study sites.
• Write study visit reports and follow up letters within the timeline
established by applicable SOPs and guidelines
• Coordinate timely shipment of clinical supplies and study drug to sites
• Ensure proper storage, dispensation and accountability of clinical
supplies and study drug.
• Maintain adequate site tracking records.
• Follow up of drug safety issues and safety reports in timely manner, if
applicable.
• Communicate site study issues, concerns, and progress to Clinical
Research Manager, Project Manager and Clinical Team Lead
accordingly.
• Assist with data query form (incl. query process).
• Perform telephone- monitoring activities in order to obtain study status
information.
• Development and implementation of corrective actions when
appropriate.
• Prepare /review all patients tracking records.
• Input and maintain study information concerning subject status of
financial reimbursement to sites.
• Conduct and assist with administrative activities as a member of the
project team.
• Mentor for Site Manager and/or Site Manager II, when assigned
• Conduct on the job training and formal training to other Site Managers.
• Collaborate with Clinical Research Manager/ study teams to resolve
site issues
• Review study visit reports, follow-up letters and site communication
generated by other site managers for timeliness, quality, consistency,
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5. Revised 07/2016
and appropriate documentation and resolution of issues, with support
from Clinical Team Lead or Clinical Research Manager as needed.
• Participate in routine study progress meetings, face to face or via
teleconference.
Reason for leaving: RPS was acquired by PRA and client initiated
re-organization of in-house support team. Rehired 2/2016
DEC 2013 to MAR
2014
INC Research, Raleigh, NC (Contract)
Senior/Lead Clinical Research Associate
• Tracking of regulatory documents in Trial Master File
• Reconciliation of Serious Adverse/Clinical Endpoint event
queries/supporting documentation
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and project management
team
• Contribute/lead team meetings
Reason for leaving: Project hired to lead was cancelled by client within 3
weeks of hire. Other position offered was not a lead position.
JUL 2013 to DEC
2013
Inventiv Clinical Health, Inc, Charlotte, North Carolina
Dedicated to Allergan (Contract/FSP)
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out, including site set-up for eye exams, and performing all start-up
activities including obtaining the CDA.
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations. Collected updated
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6. Revised 07/2016
documents and forwarded them to appropriate in-house resources.
• Set up/requested site access to IWRS, learning and EDC systems
• Served as liaison between the study sites and Inventiv/Allergan
project management team
• Performed quality checks on mandated study systems at the site level
Reason for leaving: Allergan was sold, contract was cancelled
Role-JAN 2013 to
JUL 2013
(Employed at
Covance)
Jun2007-
JUL2013)
Covance Clinical Development Services, Princeton, NJ
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out
• Conducted on-site monitoring to verify that the rights and well-being of
human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial was
conducted in compliance with the currently approved protocol, with
GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and Covance project
management team
• Spear-headed recruitment plans at individual sites identified as low
enrollers
• Initiated communications with sites during cohort teleconferences
• Initiated site plans for resolution of queries for data cleaning cycles
Reason for leaving: Desired smooth transition from Project Manager back
to CRA
JUL 2012 to JAN
2013
Covance Clinical Development Services, Princeton, NJ
Project Manager, Oncology, Early Clinical Development
• Leaded the core project team as directed by Project Director(s) to
facilitate their ability to lead the project team
• Spear-headed cross unit coordination both internally and externally,
inclusive of sub-contractors for projects utilizing one or more
Covance services or sites
• Tracking of project resource needs and contribute to contingency
planning for key resources
• Assist in monthly financial reconciliation activities/meetings (hours
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7. Revised 07/2016
SEP 2009 to JUL
2012
burned, etc.)
• Management of vendors including conducting monthly/adhoc
meetings and managing logistical issues
• Initiation of a successful design, implementation, tracking, and
revision of project plans for assigned projects
• Contribute to improvements to enhance the efficiency and the
quality of the work performed on assigned projects
• Ensure that all staff allocated to assigned projects adhere to
professional standards and SOPs established for clinical research
• Provide performance feedback of team members to respective
supervisors
• Acted as a lead recruitment specialist developing process and
procedures for individual sites in an effort to optimize enrollment
Reason for leaving: Desire to return to a position that interacted more
directly with sites in the clinical environment.
Covance Clinical Development Services, Princeton, NJ
Associate Project Manager
• Assist in the leadership of the core project team as directed by
PM/SPM/PD to facilitate their ability to lead the project team
• Assist in the cross unit coordination both internally and externally,
inclusive of sub-contractors for projects utilizing one or more
Covance services or sites
• Assist in the management and tracking of project resource needs
and contribute to contingency planning for key resources
• Assist in monthly financial reconciliation activities
• Management of vendors including conducting monthly meetings and
managing logistical issues
• Assist in the successful design, implementation, tracking, and
revision of project plans for assigned projects
• Contribute to improvements to enhance the efficiency and the
quality of the work performed on assigned projects
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8. Revised 07/2016
JUN 2007 to SEP
2009
APR 2007 to JUN
2007
• Ensure that all staff allocated to assigned projects adhere to
professional standards and SOPs established for clinical research
• Provide performance feedback of team members to respective
supervisors
• Perform other duties as assigned by management
• Acted as a lead recruitment specialist developing process and
procedures for individual sites in an effort to optimize enrollment
• Site selection for new studies (initiated questionnaire, complied and
tracked answers to feasibility questions)
Covance Clinical Development Services, Princeton, NJ
Senior Clinical Research Associate
• Conducted all aspects of clinical monitoring from screening to close-
out
• Conducted on-site monitoring to verify that the rights and well-being
of human subjects are protected; ensured trial data was accurate,
completed, and verified from source documents; and that the trial
was conducted in compliance with the currently approved protocol,
with GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and Covance project
management team
• Performed lead CRA responsibilities on assigned projects such as
initiate study-wide query reports, tracking of query resolution, and
trip report review/approval
• Contribute to content of newsletter
• Lead weekly/monthly CRA meetings
• Quality control visits for CRAs
• Review/tracking of CRA expenses
MDS Pharma Services, Irvine, CA
Clinical Team Leader
• Conducted all aspects of clinical trial monitoring from screening to
close-out
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9. Revised 07/2016
JUL 2002 to APR
2007
• Conducted on-site monitoring to verify that the rights and well-being
of human subjects are protected; that reported trial data are
accurate, complete, and verifiable from source documents, and that
the trial is conducted in compliance with the current approved
protocol, with GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and MDS Pharma project
management team
• Performed lead CRA responsibilities on assigned projects
• Participated in developing departmental procedures and initiatives to
improve process/efficiencies
• Acted as a mentor to less experienced CRAs and assisted in their
development and training
• Participated in recruitment of new staff
• Management of direct reports including expense report review,
project allocation, trip report review, and ongoing training for new
and established clinical research associates
MDS Pharma Services, Irvine, CA
Senior Clinical Research Associate
• Conducted all aspects of clinical trial monitoring from screening to
close-out
• Conducted on-site monitoring to verify that the rights and well-being
of human subjects are protected; that reported trial data are
accurate, complete, and verifiable from source documents, and that
the trial is conducted in compliance with the current approved
protocol, with GCPs, ICH Guidelines, and FDA regulations
• Served as liaison between the study sites and MDS Pharma project
management team
• Performed lead CRA responsibilities on assigned projects
• Participated in developing departmental procedures and initiatives to
improve process/efficiencies
• Acted as a mentor to less experienced CRAs and assisted in their
development and training
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10. Revised 07/2016
JUL 1996 to JUL
2002
THERAPEUTIC
AREA
EXPERIENCE
• Participated in recruitment of new staff
Reason for leaving: MDS was acquired by INC and new offer for
better position as lead CRA
Heart Center Research, Port Charlotte, FL
Certified Clinical Research Coordinator / Manager
• Managed clinical research staff at multiple locations
• Assisted hospitals to implement IRB/Ethic Committee internal
systems to support clinical research
• Performed all aspects of study coordination including phlebotomy
and lab processing from study start-up through close-out for both
inpatient and outpatient studies
• Performed standard nursing duties in cardiac catheterization
laboratory including management of arterial lines and preoperative
and post-operative care
• Conducted in-services for hospital staff prior to implementing clinical
studies
Reason for leaving: Offer for CRA position
Phase I – Neurology-Parkinson’s Disease
Phase II – Oncology-Breast CA, Pancreatic CA, Metastatic Liver CA,
Kidney CA, Childhood Leukemia, Melanoma, Multiple Myeloma,
Lymphoma (Hodgkin’s and non-Hodgkin’s) Infectious Disease-
Complicated Urinary Tract Infection, Complicated Intra-Abdominal
Infections, Cardiology-Atrial Fibrillation, Acute Myocardial Infarction,
Hyperlipidemia, Acute Coronary Syndrome, Hypertension, Claudication,
Ventricular Tachycardia Hematology- Chemotherapy Induced Anemia,
Sickle Cell Anemia, Graft Versus Host Disease, Endocrinology- Types-1
and 2 Diabetes Mellitus, Obesity Neurology-Migraine
Phase III –Cardiology-Atrial Fibrillation, Acute Myocardial Infarction,
Hyperlipidemia, Acute Coronary Syndrome, Hypertension, Claudication,
Hematology-Anemia Endocrinology- Type-2 Diabetes Mellitus
Dermatology-Hypotrichosis, Urology-Overactive Bladder,
Ophthalmology: Dry Eye Syndrome Oncology- Breast Cancer (PR/HR
neg, HER2), Melanoma, Solid Tumors
Phase IV –Cardiology-Hypertension, Hyperlipidemia, Diabetes
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11. Revised 07/2016
CURRENT
PROFESSIONAL
AFFILIATIONS
Member Association of Clinical Research Professionals since 1996, So
CRA
ADDITIONAL
RELEVANT
TRAINING
Leadership Training-Covance
Quality of Life (QO) Questionnaires
Mini-Mental State Examination (MMSE)
Rankin Stroke Scale
New York Heart Association Heart Failure Classification (NYHA)
RAVE
Inform 4.0, 4.5, 5.0
CURRENT
LICENSURE &
CERTIFICATIONS
Florida Department of Nursing PN 1233441 (Expiration Jul 2017)
Certified Clinical Research Coordinator (Expiration Nov 2017)
COMPUTER
SKILLS
Word, Excel, PowerPoint, Oracle, MediData, RAVE, Inform, Informatics,
Outlook
LANGUAGES English
PROFESSIONAL
HONORS &
AWARDS
Ace Award of Excellence-Covance 2010
Signature________________________________ Date__________________
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