1. Wanda J Peterson, MA CCRC
Phone 614-263-4400
wpeterson@hometownurgentcare.com
4400 N High St., Suite 101
Columbus, Ohio 43214
Professional Experience
Hometown Urgent Care & Research
Columbus, Ohio
November 2015 - present
Senior Clinical Research Coordinator
• Responsible for orchestrating and managing the critical study documentation of data
collection necessary for each study investigation
• Participated in Patients assessment, Data Collection, and Patient Training
• Maintained study records. Subject recruitment, screening and enrollment
• Liaison with Sponsors, Pharmaceutical Companies and IIms
• Study implementation Study close-out or termination activities
• Established and "Open Door" policy to assist the staff at any anytime
• Ensured GCP on clinical study phases II-IV
Novella Clinical
Morrisville, NC
May 2013- November 2015
ISSCAssociate
Site Support (contractor-Nov. 2012- May 2013)
• As required provides updates during weekly client teleconferences and internal team
meetings
• As required, interacts with sponsors, clinical and contracts teams to discuss sites to be
focused on for activation
• Participates in the development of the study qualification questionnaires and review
protocols, drawing on medical knowledge and regulatory expertise, to interview sites for
potential involvement in studies or trials
• Creates and assists in the dissemination of Confidential Disclosure Agreements (CDAs)/
Questionnaires to sites and follows up accordingly to ascertain interest and to meet study
timelines
• Participates in the review and negotiation of the CDAs according to and country specific
requirements
• May review and negotiate Informed Consent Forms and follows up with sites and sponsors
accordingly
• Assists sites with local IRB/ethics committee submissions
• Contacts sites directly, or through local CRA, as required to resolve issues before IRB/ethics
committee submission and final review
• Notifies Regulatory Affairs department when initial essential documents are available for
review. Works with Regulatory Department to resolve any concerns
Confidential
2. ·.
Wanda Peterson
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• Assistswith the creation oftemplates for regulatory documents specific to local and central
Institutional ReviewBoard(IRB)/ethics committee submission requirements. Assistswith
assembly and distribution of regulatory documents to sites either directly or through local
CRAsin specific countries
• Managesquality and regulatory compliance documentation among investigational sites
• Adheresto study timelines, documents study challenges and communicates updates to
Project Managerand ISSCManagement
• Managesperiodic investigator site file audits maintained at Novellathroughout a project to
ensure compliance with GCPand Novella'sstandard operating procedures. Communicates
directly with the site, or with local CRAsin various countries, to achieve stated objectivesand
to ensure files are maintained in an audit ready condition in at all times.
• Enters Investigator names in the ClinicalTrial Management System (CTMS)database.
• Updates CTMSwith document collection and all communication made with site during start-
up phase
• Collects and reviews regulatory documents for completeness and accuracy. Responsible for
updating CTMSsystem with receipt of completed documents, scanning to the shared (G)
drive, record according to file tracking process and submitting to the file room to be filed
throughout the study. Updates tracking forms asrequired
• Distributes reportable expedited safetyreports and crossreports to sites as needed. Also
responsible for tracking and filing of this activity
• Submit ongoing regulatory documents to clients asneeded
• Accountable for maintaining project activities within scope and budget
• Assures that the appropriate Novella and/or sponsor SOPsare followed
• Ensures all project documentation is appropriately filed per Novella SOPs
• Assistswith identification of out of scope activities to ISSCManagement and assures that
such activities do not begin until the client provides authorization
• Assists with mentoring ofjunior staff
• Performs other duties asrequired
Ohio Health Research Institute
Columbus, OR
Apr. 2010- Nov. 2012
Certified ClinicalStudy Coordinator,ClinicalTrialManager
• Assisted resident intern with writing of protocol, budgets and regulatory documents.
• OverviewedDaily ClinicalOffice Business,Reviewwith Principal Investigator newStudies to
acceptfor the Clinic
• Responsible for orchestrating and managing the critical study documentation of data
collection necessaryfor eachstudy investigation
• Participated in Patients assessment, Data Collection, and Patient Training
• Maintained study records. Subject recruitment, screening and enrollment
• Liaison with Sponsors, PharmaceuticalCompanies and IRBs
• Study implementation Study close-out or termination activities
• Established and "Open Door"policyto assist the staff at any anytime
• Ensured GCP on clinical study phases II-N
3. Wanda Peterson
Page 3 of7
Ohio Clinical Research Partners, LLC
Columbus,OH
Sep. 2007- Dec. 2009
Certified ClinicalStudy Coordinator,Lead Coordinator
• OverviewDaily Clinical Office Business, Reviewwith Principal Investigator new Studies to
acceptforthe Clinic
• Responsible for orchestrating and managing the critical study documentation of data
collection necessaryforeachstudy investigation
• Participated in Patients assessment,Data Collection, and Patient Training
• Maintained study records. Subject recruitment, screening and enrollment
• Liaison with Sponsors, Pharmaceutical Companies and IRBs
• Study implementation Study dose-out or termination activities
• Established and "Open Door"policyto assist the staffat any anytime
• Ensured GCPon clinical study phases II-IV
Radiant Research
Columbus, OH
Sep. 2007- November 2009
Regulatory Coordinator/Certified ClinicalStudy Coordinator (Contingent)
• Responsible for orchestrating and managing the critical study documentation ofdata
collection necessaryfor eachstudy investigation
• Participated in Patients assessment, Data Collection, and Patient Training
• Maintained regulatory documents, study records. Subject recruitment, screening and
enrollment
• Liaison with Sponsors, PharmaceuticalCompanies and IRBs
• Study implementation Study dose-out or termination activities
PSB
Mt. Gilead, OH
Jun. 2007-Feb. 2008
ClinicalStudy CoordinatorJob Title
• OverviewedDaily Clinical OfficeBusiness,Reviewedwith Principal Investigator newStudies
to acceptforthe Clinic
• Adjusted and reviewedstudy budgets for submission
• Responsible for orchestrating and managing the critical study documentation of data
collection necessaryfor eachstudy investigation
• Participated in Patients assessment, Data Collection, and Patient Training
• Maintained regulatory documents, study records. Subject recruitment, screening and
enrollment
• Liaison with Sponsors, Pharmaceutical Companies and IRBs
4. Wanda Peterson
Page 4 of7
• Study implementation Study close-out or termination activities
• Established and "Open Door" policy to assist the staffat any anytime
• Ensured GCP on clinical study phase II - IV
R & RResearch, Smith Clinic
Marion, OR
Mar. 2007- Aug. 2007
ClinicalStudy Coordinator
• OverviewedDaily ClinicalOffice Business, Reviewedwith Principal Investigator newStudies
to acceptfor the Clinic
• Responsible for orchestrating and managing the critical study documentation of data
collection necessary for eachstudy investigation
• Participated in Patients assessment, Data Collection, and Patient Training
• Maintained study records. Subject recruitment, screening and enrollment
• Liaison with Sponsors, Pharmaceutical Companies and IRBs
• Study implementation Study close-out or termination activities
• Established and "Open Door" policyto assist the staffat any anytime
• Ensured GCPon clinical study phases II-IV
Optimed Research, LTD
Columbus, OR
Apr. 2005- Mar. 2007
ClinicalResearch Study Coordinator&Regulatory Document Specialist
• Compiled and submitted pre-study documents to sponsor
• Complete and submit all regulatory documents for clinical trials, Privacycompliance officer,
IRBConsultant, Liaison with Sponsor
• Responsible for orchestrating and managing the critical study documentation, ensure data
collection necessaryfor each study investigation, Study implementation, Maintaining Study
Records, Ensure storage of Professional Documents from current Studies
• AssistStudy Coordinator with clinical trial screening, enrollment and treatments CRF
management/Informed Consent Training and Patient Consent Approval ofInformed consent
• Patients testing regarding specific Study
• Study close-out or termination activities, Ensure ProfessionalArchiving of Documentsfor
close-out studies.
Mentored NewRegulatoryCoordinator on all aspect ofthe position and duties. Guided her
through all Facetsof eachIRB,Sponsor and Pharmaceutical Company. Tested her abilities to
ensure she wasprepared to function in the Regulatory Coordinator solo
5. Wanda Peterson
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OSU Primary Care Net Work/Dept. ofSurgery
Columbus, OR
Jul. 2004- Apr. 2005
MedicaLAssistant
• Checked in Patients for specific ordered procedure, ensured patient comfort and safety
Supported and Completed Residents with patient Daily care, Completed all vital document
regarding patient, Reviewed Patient Charts to ensured patients need were addressed
• Assist with minor Medical issues and Surgeries
• Pre and post-op care of patients ensuring comfort and safety
• Overviewed Patients safety during Discharge to Family, Completed necessary discharge
documents
Compensation Management Healthy Systems
Dublin, OR
Jul. 2000- Jul. 2004
Senior CaseExaminer
• Public Relations Liaison for Office of Dublin Bureau of Compensation
• Medical Manager of Workman Compensation claims
• Counselor to Patients filing for Compensation Claim Documents
• Liaison between Bureau of Workman Compensation, the Physicians of Documents, records
and Injured Workers, (Patients)
• Ensured all Conversations, Documents, Records were filed and stored in the correct orderly
manner in which Legally stated in the BWC Regulations
Forum Health Beeghly Medical Center
Boardman,OH
Jun. 1997- Apr. 2000
Register & ClinicAssistant
• Organized, completed ensured patients documents and records were completed and stored in
designated safe location
• Registration of patients for treatment for the Emergency Room or Urgent Care, which ever
was needed according the patients statements
• Made sure Patients were as comfortable as could be while waiting to see the Physician for
treatment
• Indicated to the Physician what the Patients stated, so the Physician could determine who
need to be seen in what specific order
Functioned in a Clinical Medical Assistant role assisting the physician with treatment of
patient during treatments of the Patient
• Check the Patient out of the Clinic and ensure they knew they could call us during our open
hours
6. Wanda Peterson
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Mahoning County Juvenile Justice Center
Youngtown, OR
Jan. 1996- 1997
Correction Officer& Youth Leader
Registered Patients for treatment in counseling and took history
Ensured Patients were settled in their specific areas
• Recorded information in specific safe and locked area
• Supervised female students for serving detention commitments, Available for any situations
that might occur where might need my assistance
• Checked Female students out of facility when students had finished their detention
• Wrote comments clinically appropriate to student's progress and filed them in appropriate
location
Alpha Therapeutic Corporation
Youngtown, OR
Oct. 193-1997
MedicalAssistant Technician
• Supervisor, Responsible for Documents, Quality Assurance, Phlebotomist, Plasmapheresis Donor
Center, Responsible for Recruiting Donors and Monitoring Donations
Education
Harding Business College, Youngtown, OH
Associates Degree: Medical Assistant Technology
Related Course Work:
Certified EKG, CPR, BLS, and Breathing Alcohol Technician
Triage, Vital Signs, Prescription writing, ICD-9 Coding
Insurance certifications, Medical records processing, Diabetic Teaching, OSHA
C9 Authorizations, BWC and MCO knowledge FROI
Phlebotomy, venipuncture, Capillary puncture, injections, immunization
Ear irrigations, Urine drug screen, Pap smear, OCL splinting, breathing Treatment
Sterile/Dry Dressing. Sterilization of Surgical Instruments
CITI Training, lATA Training, GCP Knowledge/Training
CCRC March 2008
7. . . . ."
Wanda Peterson
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Research Experience
• A Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled, Study to assess
the Efficacy and Safety of XXX for 12 - Weeks in Patients aged 4 to 12 years with Persistent
Asthma
• A 16-Week, Randomized, Double-Blind Placebo Controlled Multi-Center Trial of XXX in Patients
with Post herpetic Neuralgia (PHN)
• Safety and Efficacy of XXX treatment in place of the XXX or the XXX or XXX in triple agent
therapy for Type 2 Diabetes Mellitus Adult Subjects with Unsatisfactory Control
• Dose- Ranging Study Assessing the Safety and Efficacy of XXX Gel When Applied Topically for
90
Days to Subjects with Diabetic, Neuropathic, Foot Ulcers
• One versus two versus three injections of XXX as added on to oral and XXX Basal Therapy in
Type 2 Diabetes
• XXX administered premeal vs. post meal in adult subjects with Type 2 Diabetes Mellitus receiving
XXXX as basal insulin: A Multi-Center, Randomized, Parallel, Open Label Clinical Study
• An Open-Label Comparison to Evaluate the role of XXX versus XXX in combination with XXX in
Type 2 Diabetes Mellitus in Patients not responding adequately to XXX Monotherapy
• A Randomized, Double-Blind, Parallel-Group Trial to Assess the Efficacy and Safety of XXX
Compared with Placebo when added to XXX in Patients with Type 2 Diabetes
• A Multicenter, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate
the Clinical Effect of Oral XXX Versus Placebo During the Allergy Season in Patients With
Seasonal Aeroallergen Sensitivity and Chronic Asthma Which is Also Active During Allergy
Season
• A Randomized, Double-Blind, Multi-Center, Active Comparator Study to Determine the Efficacy
and Safety of XXX versus XXX in Subjects with Moderate to Severe Osteoarthritis (OA) Pain
• Placebo Controlled Randomized Study of XXX, XXX, and XXX TID in the Treatment of Chronic
Low Back Pain
• A Phase 3, 53 Weeks Study on Analgesic Efficacy and Safety ofXXXX: 26-Week, Randomized,
Parallel-Group, Double-Blind, Placebo (13 Weeks) - and XXXX (26 Weeks)-Controlled,
Multicenter Study ofXXXX with a 26-Week XXX Controlled Safety Follow-up in Subjects with
Osteoarthritis of the Knee, and a 1-Week Post-treatment Safety Follow-up
• A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Asses the
Safety and Efficacy of XXXX, in Overweight and Obese Patients
• A Randomized, Double-Blind, Parallel Group Study Evaluating the Efficacy and Safety of Co-
Administration of a Triple Combination Therapy ofXXXX, XXXX, and XXXX in Subjects with
Hypertension
• Phase lIb Clinical trial to Evaluate the Safety, Tolerability, and Immunogenicity of XXXX in
Patients on Chronic/Maintenance XXXX
• A Multicenter, Randomized, Double-blind, Double-dummy, Placebo and Active Controlled Study
to Assess the Efficacy, Safety and Tolerability ofXXXXX compared to XXXXX and Placebo in
Patients with Type 2 Diabetes Mellitus Inadequately Controlled with XXXX
• A Randomized, Open-Label, Blinded-Endpoint, Parallel-Group Trion ofGI Safety of XXXX
Compared with Non-Selective XXXXXXXX-XXXXXXX in Osteoarthritis Patients
• A Phase 3, Double-Blind, Randomized, Factorial, Efficacy and Safety Study of xxx-xxx plus
XXXXX Fixed-Dose Combination in Subjects with Moderate to Severe Hypertension