Clinical Research Associate

Erin Colarusso

*** **** ******

Boonton, NJ *****

Cell Phone 908-***-****

THERAPEUTIC EXPERIENCE

Oncology: Breast; Leukemia, Lymphoma; Ovarian; Lung; Prostate; Kidney, GIST

Peripheral Blood Stem Cell Transplantation

Digestive System: Crohn’s Disease

Infections/Parasitic Diseases: HIV

Dermatology: Head Lice; Hidradenitis Suppurativa

Respiratory: Seasonal Allergies

Women’s Health: Uterine Fibroids, IVF

Nervous System/Sense Organs: Multiple Sclerosis

Musculoskeletal: Lupus

Immunotherapy: aPDL1 for Lung Cancer

Targeted Radioactive Isotope for treatment of bone metastases in Breast Cancer

PROFESSIONAL EXPERIENCE

LabCorp/Covance, Inc. Sr. Clinical Research Associate II July 2019 - Mar 2020

Contracted to Merck

Was onboarded successfully to the Merck GCTO group within an abbreviated timeline due to immediate on-study need

Managed the start-up of 8 unique sites, most at large university hospitals with several satellite sites.

Liaised with the study start up teams and in-house regulatory teams to keep each site’s trial master file audit-ready.

[enter Coronavirus grounding of CRAs]

IQVIA, Durham, NC Sr. Clinical Research Associate Jan 2019 – May 2019

Contracted to Eli Lilly

Was fully embedded into the Eli Lilly oncology group

Performed site validation visits to assess the fitness of specific sites to perform Lilly protocols as written

Brought sites from the validation stage, through the site initiation phase, to screening & enrolling eligible subjects, collecting accurate & usable data and closing out sites as needed.

Craresources, Talahassee, FL Sr. Clinical Research Associate Oct 2017 – Jan 2019

Contracted to UroGen Pharma

Monitor study sites per the current protocol monitoring plan – all aspects of monitoring including regulatory review & reconciliation, IP and study supply accountability, site staff training and management, issue escalation as needed

Participated in two internal site audits, not for cause. One site I owned had no issues. The other site I inherited had several issues. I created and executed CAPA to completion.

Facilitate subject recruitment & participation by way of arranging Ubers to site, and other helpful extras as needed

Manage and inventory site-specific IP & ancillary study supplies

Proofed & edited CRFs and other site/subject-facing study documents that were not created by those whose first language is English, for use in the US and Canada

Trained & onboarded Sr. CRAs quickly (see one/do one)

Performed all types of monitoring visits and worked with multiple sites from study start-up to COV

ProTrials, Inc, San Jose CA Sr. Clinical Research Associate Mar 2017 – Jun 2017

Contracted to Puma Biotech

Assisted with the preparation of and/or review of synopses, protocols and amendments, and responsible for ensuring creation of ICFs

Responsible for ensuring development of site-level Study Documents (e.g. reference manuals, Laboratory manuals, CRF Completion Guidelines, forms, etc.) and availability of site supplies (e.g. laboratory kits, clinical trial materials, etc.) within designated timelines

Responsible for ensuring development of, contributing to and/or writing site level project plans, including the monitoring plan for any assigned projects, drug accountability and reconciliation plans

Managed site start-up activities and site initiation within given timelines.

Managed drug accountability process, as applicable to resolve regarding any drug-related issues (e.g., re-test updates and documentation, drug supply updates, etc.)

Produced and provided clinical research project metrics and functional department metrics as required

PPD, Boonton, NJ Principal Clinical Research Associate July 2013-Jan 2017

Contracted to Genentech

Worked on two multicenter studies evaluating patients with myelofibrosis. One of the studies was in Phase II, the other was in Phase III

Worked on a randomized, open label study for 3rd line treatment for breast cancer in the metastatic setting

Worked closely with the CTM to coordinate the activities of CRAs on the project team to ensure clinical deliverables were met

Performed all duties of a Senior CRA as listed in job title below

Monitored investigator sites, with a particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entries

Recommended processes to Clinical Management that optimize the use of project resources

Provided mentoring and support to less experienced members of the project team and advice on training and quality issues.

Assisted colleagues with site visits and site calls, when needed

Served as resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues

Worked with the Remote Site Monitoring Model

Inventiv Health, Inc., North Chicago, IL Senior CRA October 2012 - May 2013

Contracted to AbbVie

Worked as monitor for four Phase II, Phase IIb, Phase III trials in Women’s Health and Dermatology with responsibility for 12 investigative sites across the Northeastern U.S

Research Pharmaceutical Services, INC. (Re-branded by Merck), Ft Washington, PA Senior CRA Apr 2012 - Aug 2012

Worked as monitor for four Phase II & Phase III trials in Women’s Health and Allergy/Asthma with responsibility for 12 investigative sites across the Northeastern U.S

Merck (Prev. Schering Plough Research Inst.), Kenilworth, NJ

CRA Apr 2006 - Apr 2012

Worked as monitor for 10+ Phase II, &Phase III trials in Women’s Health, Immunology, Infectious Diseases, Oncology, Allergy/Asthma with responsibility for up to 21 investigative sites across the Northeastern U.S

Schering Plough Research Institute, Kenilworth, NJ

International Clinical Project Specialist Oct 2005 - Apr 2006

Liaison for international CRAs in Europe & Canada

Responsible for trouble-shooting, procedure guidance, first contact

Documented quality review before submission to Global Regulatory Affairs

Reported to superiors weekly with status of all sites and identified problems/potential problems

Target Health, Inc., New York, NY CRA Nov 2004 – Oct 2005

Responsible for monitoring, quality assurance and resolution of queries for research data entered into Target Health e*CRF system, a unique electronic data capture (EDC) application

In-house and in-field tracking of data

Site qualification and site assessment

Individual and large group training on EDC methods and best practices

Liaison between sponsors, the FDA and research sites

Responsibilities included a Phase III dermatology NDA, a pre-market maintenance study for a new prostate cancer treatment and a large health initiative protocol

NY Presbyterian Hospital– Columbia Campus

Study Coordinator/Data Manager Nov 1999 – Nov 2004

Stem Cell Transplant, Hematology & Immunotherapy Programs

Liaison between the FDA, the Western IRB, the CUMC IRB and up to seven principal investigators

Managed the International Bone Marrow Transplant Registry Database for the CUMC Stem Cell Transplant Program

Completed case report forms, both on paper and via web-based CRF applications for investigator-initiated and sponsored studies

Reviewed hospital charts of all patients on stem cell transplant and hematology protocols for the purpose of identifying previously unreported SAEs

Created consent forms and initial study submissions for review by the CUMC Protocol Research and Monitoring Committee, an NCI designated group of physicians

APPLICABLE SKILLS

Remote Monitoring

Risk-based Monitoring

CTMS – both home-grown and commercial

IVRS/IWRS – both home-grown & commercial

EDC – home-grown, commercial – Medidata RAVE, InForm, Target Health, CRF Health, Bracket

Patient eDiaries - ePro

eTMF – Veeva Vault, home-grown

PROFESSIONAL DEVELOPMENT

Scientific education classes with focus on a B.S. in Human Ecology, Rutgers University, New Brunswick, NJ, Sep 1992 to May 1997

Fundamentals of Clinical Research

Effective Business Partnerships – 2005

Scientific Fraud and Misconduct – 2006

Presentations with Power – 2007

Oncology Therapy Area Training – 2007

Good Clinical Practices – 2008

Allergy Therapy Area Training – 2009

Asthma Therapy Area Training – 2009

Anti-Infectives Therapy Area Training – 2009/2010

HIPAA training – 2004 through 2013

Clinical Specimen Management – 2011

Regulatory Document Training – 2011

Monitoring Basics – 2005 to 2013

PUBLICATIONS AND PRESENTATIONS

Publications:

Vahdat LT, Balmaceda C, Papadopoulos K, Frederick D, Donovan D, Sharpe E, Kaufman E, Savage D, Tiersten A, Nichols G, Haythe J, Troxel A, Antman K, Hesdorffer CS: Phase II trial of sequential high dose chemotherapy with XXX, XXX and XXX, XXX, and XXX with peripheral blood progenitor support in women with responding metastatic breast cancer, Bone Marrow Transplantation, 2002

**The above study was supported in part by US Public Health Service Grant P30-CA13696-21, NCI R21CA 66244-01 and P20CA 6244-01 and Grant- in- Aid Programs of Amgen and Bristol Meyers Squibb Oncology

Linda T. Vahdat, Deirdre J. Cohen, Debra Zipin, K. Steve Lo, Deborah Frederick, Diana Donovan, Erin Sharpe, David Savage, Amy Tiersten, Gwen Nichols, Andrea Troxel, Charles S. Hesdorffer: Randomized trial of low dose interleukin-2 vs. cyclosporine A and interferon-α after high dose chemotherapy with peripheral blood progenitor support in women with high risk primary breast cancer

**The above study was supported in part by US Public Health Service Grant P30-CA13696-21, NCI R21CA 66244-01 and P20CA 6244-01

Jules T. Mitchel, MBA, Ph.D., Eva Jurewicz, BA, Katie Flynn-Fuchs, MS, Erin Sharpe, Glen D. Park, PharmD: The Role of CRAs in the Development and Implementation of Internet-Based Clinical Trial Applications: New Career Opportunities Monitor, Oct 2005.

Poster Session

08 MAR 2006 - Dose Ranging Study of a Non-Pesticide Lice Asphxiator for the Treatment of Head Lice, American Society for Clinical Pharmacology and Therapeutics (ASCPT) annual meeting

COMPUTER EXPERIENCE

Windows XP, MS Word, PowerPoint, MS Excel, MS Access, CTMS, EDC (Inform, Phase Forward, Medidata Rave, EMR (various institutional systems), IXRS (ClinPhone)

CLINICAL TRIAL EXPERIENCE

Principal CRA:

Oncology: An Open Label Assessment of Safety and Efficacy of XXX in Subjects With Primary Myelofibrosis, Post Essential Thrombocythemia-Myelofibrosis and Post Polycythemia Vera-Myelofibrosis Who Have Platelet Counts of 50 109/L to 100 109/L

Oncology: A Randomized, Double-blind, Placebo-controlled Study of the JAK Inhibitor XXX Administered Orally to Subjects with Primary Myelofibrosis (PMF), Post- Polycythemia Vera- Myelofibrosis (PPV-MF) or Post- Essential Thrombocythemia-Myelofibrosis (PET-MF)

Oncology: A Study of xxx Plus xxx versus xxx Plus xxx in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2-Directed Regimens in the Metastatic Setting

Study Coordinator/Data Manager:

Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Primary Light Chain Amyloidosis

Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Lupus (1 subject – compassionate use)

Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Multiple Sclerosis (1 subject – compassionate use)

Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Prostate Cancer (1 subject – compassionate use)

Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Lupus (1 subject – compassionate use)

Oncology: Study of High-Dose XXX and Autologous Stem Cell Transplantation in Patients With Ovarian Cancer

Oncology: XXX Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma

Oncology: Combination Chemotherapy Followed by Peripheral Stem Cell Transplantation and Interleukin-2 in Treating Patients With Acute Leukemia

Oncology: Chemotherapy Plus Peripheral Stem Cell Transplant in Treating Patients Who Have Multiple Myeloma or Primary Systemic Amyloidosis

Oncology: Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Recurrent or Persistent Epithelial Ovarian Cancer, Fallopian Tube, or Primary Peritoneal Cancer

Oncology: Phase II trial of sequential high dose chemotherapy with XXX, XXX and XXX, XXX, and XXX with peripheral blood progenitor support in women with responding metastatic breast cancer

Oncology: Randomized trial of low dose XXX vs. XXX and XXX after high dose chemotherapy with peripheral blood progenitor support in women with high risk primary breast cancer

Oncology: Randomized, blinded study of XXX to prevent mucositis in Patients undergoing high-dose chemotherapy and Peripheral Blood Stem cell Transplantation

CRA I:

Dermatology: Dose Ranging Study of a Non-Pesticide Lice Asphxiator for the Treatment of Head Lice

CRA II:

Infection/Parasitic Diseases: XXX, a XXX, Added to an Optimized Antiretroviral Therapy for Previously Treated HIV

Infections/Parasitic Diseases: Efficacy and Safety of XXX in HIV-Infected Treatment-Naïve Subjects

Infection/Parasitic Diseases: XXX in HIV-Treatment Experienced Subjects

Infection/Parasitic Diseases: XXX Treatment Protocol in HIV-Infected Subjects: A Rollover Study for ACTG Protocol XXX

Infection/Parasitic Diseases: XXX in Combination Treatment With Optimized ART Regimen in Experienced Subjects

Respiratory: A Study of XXX in Participants With Grass Pollen Allergy Symptoms, With or Without Asthma

Respiratory: Safety Study of Ragweed Allergy Immunotherapy Tablet in Subjects 50 Years of Age and Older

Oncology: Study of XXX Versus Placebo in Subjects With Either Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Women’s Health: A Phase 3, Randomized, Double-blind, Active-controlled, Non-inferiority Trial to Investigate the Efficacy and Safety of a Single Injection of XXX to Induce Multifollicular Development for Controlled Ovarian Stimulation (COS) Using Daily XXX as a Reference in Women Aged 35 to 42 Years

Women’s Health: Follow-up Protocol to Collect the Outcome and Safety of Frozen-thawed Embryo Transfer (FTET) Cycles After Cryopreservation of Embryos in Clinical Study P0XXX (Phase 3)

Digestive System: Safety, tolerability, exploratory PD & PK data of a single dose of XXX administered IV to subjects with active Crohn’s Disease

Senior CRA:

Women’s Health: Safety and Efficacy Pre-Menopausal Women with Heavy Uterine Bleeding and Uterine Fibroids

Dermatology: A Phase 3 Multicenter Study of the Safety and Efficacy of XXX in Subjects With Moderate to Severe Hidradenitis Suppurativa and currently on hormonal treatment

Dermatology: A Phase 3 Multicenter Study of the Safety and Efficacy of XXX in Subjects With Moderate to Severe Hidradenitis Suppurativa and currently not on hormonal treatment

Breast Cancer: A Study of XXX Plus XXX Versus XXX Plus XXX in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting

Urinary Tract Urothelial Carcinoma: A Phase 3 Multicenter Trial Evaluating the Efficacy and Safety of XXX on Ablation of Upper Urinary Tract Urothelial Carcinoma

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