Employment

May, 2008 -  May, 2009

Perform clinical trial initiation, monitoring and closeout activities while adhering to all applicable regulatory, Standard Operating Procedures SOPs and Project Specific Operating Procedures PSOPs.

Assists with study start-up activities.

Assists in site qualification and selection and pre-study activities to identify and evaluate potential investigators.
Assists in site evaluation and reports to Lead CRA or Project Leader as appropriate.
Assists in submission of documents to the Ethics Committees, when required.
Collects, reviews and tracks regulatory documents when required.

Assist with the development of study specific monitoring plan, annotated CRFs, monitoring conventions, tracking forms and other study related documents.

Participates in study specific training.
Assists with the preparation and coordination of investigator meetings and attends meeting.
Completes pre-study and Site Initiation visits with study site staff.

Provide status updates of pre-study and initiation activities to Lead CRA or PL

Completes initiation visits with study staff through training, reviewing regulatory requirements, collecting outstanding documents, reviewing patient screening/randomization procedures, reviewing SAE reporting requirements and reviewing drug storage and accountability procedures.
Assists in development of patient enrollment strategies with the project team and study site coordinator
Ensures proper storage, dispensation and accountability of all Investigational Product s and trial-related materials.
Completes monitoring visits to ensure the integrity of clinical data and appropriate follow up procedures, source document verification and SAE reporting in accordance with the project plan.

Manages study site activities and provides ongoing updates of site status to Lead CRA or Project Leader.

Completes in-house monitoring activities as appropriate, like updating in-house site files and completing visit reports.

Maintains tracking records for assigned sites like tracking of status and source document review per patient.
Completes study site closeout visits.

Assists with Project specific administrative activities as a member of the project team.
Ensures site registration in Investigator Database.
Responsible for representation of Kendle in a professional manner.
Increases knowledge of drug development process, therapeutic areas, Good Clinical Practices and any applicable local regulatory requirements.
Maintains home-office set-up to include computer, fax/copier printer, appropriate filing system, adequate telephone lines and voice mail system when applicable

Maintain appropriate lines of communication and use of mail and delivery services completes Kendle administrative activities in a timely manner.

Other duties and assignments as requested for the overall performance of the OU and company.

October, 2007 -  October, 2008
Clinical Research Associate

Monitoring of study personnel source documentation collection to ensure scheduling, coordinating and conducting patient visits according to protocol, FDA regulations, Good Clinical Practices GCP, International Conference on Harmonization ICH guidelines and Standard Operating Procedures SOPs for an FDA mandated post marketed study
Targeted enrollment of 60000 patients at 1300 sites
Collection, management and reporting of all source data with web based systems eCRF, EDC

April, 2007 -  October, 2007

Medical history review to determine patient s study eligibility
Scheduling, coordinating and conducting patient visits according to protocol, FDA regulations, Good Clinical Practices GCP, International Conference on Harmonization ICH guidelines and Standard Operating Procedures SOPs
Collection, management and reporting of all clinical data manually on CRFs and with web based systems eCRF
Prepare CRF source document templates
SAE reporting in compliance with federal regulations
Assisted with collection of bodily fluid specimens ; Certified Phlebotomist
Processes insurance reimbursements

Completing Study closeout activities at the close or termination of the Study at the site

1st Allergy and Clinical Research Center

January, 2007 -  August, 2007

Medical history review to determine patient s study eligibility
Top enroller of patients in clinical trials
Scheduling, coordinating and conducting patient visits according to protocol, FDA regulations, Good Clinical Practices GCP, International Conference on Harmonization ICH guidelines and Standard Operating Procedures SOPs
Collection, management and reporting of all clinical data manually on CRFs and with web based systems eCRF
Prepare CRF source document templates
SAE reporting in compliance with federal regulations
Assisted with collection of bodily fluid specimens ; Certified Phlebotomist

Processing of specimens for shipping to reference laboratories
Drug tracking and accountability

May, 2005 -  December, 2006
Research Associate

Medical history review to determine patient s study eligibility
Enrollment and retention of patients in clinical trials
Scheduling, coordinating and conducting patient visits according to protocol to GCP/ICH guidelines
Collection, management and reporting of all clinical data manually and with web based systems

Processing of specimens for shipping to reference laboratories
Drug tracking and accountability

September, 2002 -  May, 2005
Office Based Monitor/Professional Research Assistant

Created and utilized centralized subject databases ; responsible for subject initial and follow-up scheduling, randomizing
Managed research revenues and expenditures ; Developed systems to monitor and control funds
Facilitated submission of grants and contracts
Developed Research Protocols ; Supervised/Trained Research Assistant volunteers on various lab projects
Awarded grant through the Undergraduate Biological Sciences Initiative to fund my own research

Memberships/Affiliations/Awards
Student Affiliate, American Psychological Association
Student Affiliate, American Psychological Society
Officer, University of Colorado at Boulder Campus Psi Chi National Honor Society
Recipient, Biological Sciences Initiative URAP Assistantship, Summer 2003
Recipient, University of Colorado at Boulder, Community Action Program Scholarship, Fall 2003
Commendations as top enroller in US on several clinical trials
SoCRA

Clinical Presentations
Educational/Clinical presentation to diagnosed and families of MS patients
In-Service presentation to area doctors on currently enrolling clinical studies
In-Service presentation/education to site staff of protocols

Clinical Trials
Ariad/Merck
A Phase III Study of AP23573 - 07 - 302 Global Clinical Trial to Determine the Efficacy and Safety of Deforolimus as maintenance Therapy to Patients with Metastatic Soft Tissue or Bone Sarcomas

Ariad/Merck
A Phase II Study of AP23573, an mTOR Inhibitor, in Patients with Advanced Sarcoma

APT Pharmaceuticals
A Multi-Center, Randomized, Blinded Assessor, Controlled Study to Demonstrate the Efficacy and Safety of Cyclosporine Inhalation Solution CIS in Improving Bronchiolitis Obliterans Syndrome-Free Survival Following Lung Transplantation

Takeda
A Phase 2, Randomized, Active Comparator-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of TAK-442 in Subjects Undergoing Total Knee Replacement

Translational Research
A randomized, single administration, double-blind, parallel-group Phase 2 dose finding study to assess the efficacy, tolerability and safety of TRG intranasal granisetron in patients with chemotherapy-induced nausea and vomiting CINV associated with the administration of highly emetogenic chemotherapy

Allergan
Breast Implant Follow-up Study BIFS, Rare Adverse Events Study RAES, MRI and Mammography Study MRS, Child Bearing Issues Study CBIS

Acorda
Double-Blind, Placebo-Controlled, 21 - Week, Parallel Group Study to Evaluate Safety and Efficacy of Oral Fampridine-SR in Subjects With Multiple Sclerosis

Genentech
A Phase IIIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Xolair in Subjects with Moderate to Severe Persistent Asthma Who Are Inadequately Controlled with High-Dose Inhaled Corticosteroids and Long-Acting Beta-Agonists.

Biogen/Genentech
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Safety And Efficacy Of Rituximab In Adults With Primary Progressive Multiple Sclerosis. U2786g Rituximab In Multiple Sclerosis

Mount Sinai School of Medicine
A Multi-Center, Double-Blind, Randomized Study Comparing the Combined Use of Interferon Beta-1a and Glatiramer Acetate to Either Agent Alone in Patients With Relapsing-Remitting Multiple Sclerosis CombiRx

A Multi-Centre, Double Blind, Randomized, Placebo Controlled, Parallel Group Trial Investigating Methylprednisolone in Combination With Interferon-Beta-1a for the Treatment of Relapsing-Remitting Multiple Sclerosis

A Phase II/III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis

Baxter/InClin
Tolerability And Pharmacokinetic Comparison Of Immune Globulin Intravenous Human, 10% IGIV, 10% Administered Intravenously Or Subcutaneously In Subjects With Primary Immunodeficiency Diseases

Baxter/InClin
Phase I/II Determination of the Dose of rHuPH20 Required to Enable Up to 600 mg/kg of IGIV, 10% to be administered Subcutaneously in a Single Infusion Site in Subjects with Primary Immune Deficiency Diseases

AstraZeneca/Parexell
A Phase IIIB, 12 - Month, Double-blind, Double-Dummy, Randomized, Parallel-group, Multicenter Exacerbation Study of SYMBICORT pMDI 160/4.5 g x 2 Actuations Twice-daily and 80/4.5 g x 2 Actuations Twice-daily Compared to Formoterol Turbuhaler 4.5 g x 2 Inhalations Twice-daily in COPD Subjects

Genentech/Quintiles
An Epidemiologic Study of Xolair Omalizumab Evaluating Clinical Effectiveness and Long-Term Safety in Patients with Moderate to Severe Asthma EXCELS

Skye Pharma
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Stratified, Multi-center, 12 - Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination FlutiForm 100/10 g twice daily in a Single Inhaler SkyePharma HFA pMDI with the Administration of Placebo or Fluticasone 100 g twice daily and Formoterol 10 g twice daily Alone in Adolescent and Adult Patients with Mild to Moderate Asthma. 2007

AstraZeneca
A Phase IIIB, 12 - Month, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Multicentre Exacerbation Study of Symbicort pMDI 160/4.5 g x 2 actuations Twice-Daily and 80/4.5 g x2 actuations Twice-Daily Compared to Formoterol TBH 4.5 g x 2 Inhalations Twice-Daily in COPD Subjects.

Ozurdex dexamethasone ; Allergan ; For the treatment of macular edema following branch retinal vein occlusion or central retinal vein occlusion, Approved June 2009

Genentech
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of HAE1 PRO98498 in Subjects with Moderate to Severe Allergic Asthma.

Naryx/Kendle
A Phase 2, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Study Evaluating the Safety and Efficacy of SPRC AB01, Tobramycin Solution for Nasal Inhalation, in Post-Surgical Subjects with Chronic Sinusitis

Accentia/PPD
A Prospective, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study Of Intranasal Amphotericin B Suspension In Patients With Refractory, Post-Surgical Chronic Sinusitis

SkyePharma/MDS
A Randomized, Double-Blind, Placebo-Controlled, Parallel, Stratified, Multi-Center, 12 - Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination FlutiForm tm 100/10 g Twice Daily in a Single Inhaler SkyePharma HFA pMDI With the Administration of Placebo or Fluticasone 100 g Twice Daily and Formoterol 10 g Twice Daily Alone in Adolescent and Adult Patients With Mild to Moderate Asthma

Braintree/Inc.
A Double-Blind, Randomized, Parallel, Multicenter Study of Axid Nizatidine Oral Solution in the Treatment of Gastroesophageal Reflux Disease GERD Symptoms in Infants Age 30 Days 1 Year

2011 -  November, 2018

Education

Miscellaneous

AstraZeneca
A Phase II Study on Analgesic Efficacy, Safety and Tolerability of AZD3582 : A 6 - Week, Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Multicentre Study Comparing AZD3582 with Rofecoxib VIOXX in Subjects with Osteoarthritis of the Hip or Knee.
Please note that this is not a complete list of all trials monitored as a Clinical Research Associate or conducted as a Clinical Research Coordinator