Clinical Research Nurse

MaryEllen Hodges

Regional Clinical Research Associate

EDUCATION: Ashford University

Pursuing Bachelors Degree Social Science/Psychology Graduation July 15, 2011

**** – Nursing

Genessee Community College, Batavia, NY

WORK

EXPERIENCE

Dec 23, 2010-present

PRA. International, Horsham, PA

Senior Regional Clinical Research Associate

Completes project activities associated with monitoring functions of Phase III clinical research studies, as assigned. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).

March 2010-Dec. 31, 2010

InVentiv Clinical Solutions, East Hanover, NJ

Senior Regional Clinical Research Associate

Responsible for US Oncology Drug Accountability. Site management activities for unblended DA of test article.

Phase 3 US Oncology for non small cell lung CA.

November 2006 – February 2010 RPS, Inc. (ReSearch Pharmaceutical Services, Inc.), Fort Washington, PA

Senior Regional Clinical Research Associate

Completes project activities associated with monitoring functions of Phase II-IV clinical research studies, as assigned. Perform investigator site management activities in adherence to all applicable regulatory guidelines and standard operating procedures (SOPs).

• Monitor investigational sites within a territory to ensure both the quality and timeliness of clinical data.

• Responsible for the following activities during monitoring visits: ensure patient safety by reviewing informed consents and adverse event data; review clinical data for accuracy and completeness; resolve source data discrepancies and data clarification forms (generated by Data Management); assure adherence to the protocol, GCPs, and SOPs; create action plans to address site related issues; review drug accountability and compliance data; and review investigator study files for required documents.

• Participate in the debriefing and follow-up process for any GCP audits conducted at assigned clinical research sites.

• Responsible for updating Study Team Medical Monitor, Clinical Scientist and CRA Management as necessary, by completing detailed monitoring visit reports and telephone communications including, but not limited to, site-related problems, resolutions, actions taken, protocol deviations, study progress and enrollment status.

• Identify potential investigators in designated region. Participate in the initiation of new investigative sites or conduct solo initiations as negotiated with the Study Teams. Ensure the proper training of site personnel.

• Participate in special projects and attend training sessions, regional meetings and task forces as assigned by Field Manager and/or CRA Management.

• Phase 3 Study of Investigational Agent for Facial and Abdominal Cosmetic Surgery

• Phase 3 Study of Investigational Agent for Alzheimers Disease

• Phase 3 Study for Investigational Agent for Neonatal GERD

• Phase 3 Study for Investigational Agent for Pediatric GERD

• Phase 3 study for Investigational Agent for Abdominal Infection

• Phase 3 study for Investigational Agent for Lysosomal Studies

May 2006 - November 2006

MedFocus/inVentive Clinical Solutions

Senior Contract CRA outsourced to Eli-Lilly for the Northeastern US

• Responsible for Drug Accountability and Regulatory Documentation for various protocols (24) Inpatient and Outpatient

• Site monitoring of the Regulatiory Binder

• Site Monitoring for Drug Accountability

September 2004 -April 2006

Covance International, Rochester, New York

Senior Clinical Research Associate/ Field Training

• Responsible for adhering to Covance and Sponsor SOPs, FDA Regulations, ICH and GCP guidelines in all aspects of monitoring tasks.

• Reviewed case report forms for completeness and clarity, legibility, conformity to available source documentation, and adherence to protocol requirements.

• Managed clinical monitoring activities.

• Responsible for the ownership of investigator sites, including investigator/site selection, collating regulatory documentation, initiation and monitoring (source data verification, drug accountability and data collection).

• Conducted monitoring visits for clinical trials at assigned investigative sites.

• Oversight of CRA’s for monitoring purposes in field. Promoted in April 2006

July 2003 - May 2004

PAREXEL International, Rochester, New York

Regional CRA 11

• Performed the clinical monitoring aspect of designated projects in accordance with PAREXEL’s SOPs.

• As Regional CRA or Primary CRA responsibilities included managing clinical monitoring activities in addition to the ownership of investigator sites, including investigator/site selection, collating regulatory documentation, initiation and monitoring (source data verification, drug accountability and data collection) in accordance with ICH GCP guidelines.

July 2001 - March 2003

PPD Development, Orange City, FL

Regional CRA

• Participated in the conduct of multi-center clinical research studies.

• Reviewed project related materials and literature to develop a basic understanding of the protocol and therapeutic areas.

• Participated and presented at investigator meetings for assigned studies.

• Assisted in investigator recruitment.

• Evaluated, initiated, monitored and closed out sites according to applicable SOPs and FDA guidelines.

• Reviewed case report forms for completeness and clarity, legibility, conformity to available source documentation, and adherence to protocol requirements.

• Resolved CRF discrepancies and/or clarifications via site visit, telephone or fax as deemed appropriate for the study.

• Performed drug accountability, ensured prompt reporting of adverse events; and verified completeness of critical documents.

July 2000 - June 2001

Advanced Biologics, Deland, Fl

Regional CRA

• Conducted pre-study, initiation, interim monitoring, and close-out visits for clinical trials at assigned investigative sites in phases I, II, III, and IV.

• Verified site maintaining source documentation, obtaining informed consents, and completion of CRF’s in accordance with FDA requirements, ICH guidelines, GCP and Sponsor SOPs.

• Reviewed and retrieved CRFs and was accountable for the resolution of data queries.

• Performed drug accountability responsibilities including receipt tracking, dispensation and disposition of investigational study drug at site.

• Coordinated with in - house Project Team to ensure study file notebook was accurate and maintained properly by site.

• Functioned as site manager to ensure all clinical study supplies were adequate.

• Responsible for completion of trip reports following each site visit.

July 1999 - July 2000

Atlantic Urological Associates, Orange City, Fl

Clinical Research Coordinator/ Office Nurse

• Conducted clinical trial within an office setting.

• Assessed patients; administered study drug per protocol.

• Completed CRFs, documented data, performed drug accountability.

• Insured all protocol timelines were met, and performed follow up with patients.

1997

Central Florida Gastroenterology, PA, Orange City, Fl

Office Nurse

• Assisted with office procedures and patient care. Administered IV medications when needed.

1995 - 1997

Atlantic Urological Associates, Deland, Fl

Office Nurse

• Assisted with office procedures and patient care.

1995 - 1998

Olsten/Kimberly Quality Care, Deland, FL

Home Health Nurse (Pediatrics and Neonatal)

• Home visits for blood drawing as patient care.

1994 - 1995

Morales, Esserman & Feldman, MD, P.A., South Miami, FL (Obstetrics and Gynecology

Office Nurse

• Assisted with office procedures and patient care.

1986 - 1994

Baptist Hospital of Miami, Miami, Fl

Staff Nurse

• Complete and total care of the OB/GYN patient with rotation to Newborn Nursery, Neonatal ICU and Pediatrics.

1983 - 1986

William Ditkowsky, MD, Miami, Fl. ENT/Allergy

Office Nurse

• Assisted with office procedures and patient care.

1981 - 1983

Deering Hospital, Miami, Fl

Staff Nurse ICU/CCU/, Neuro-Trauma

• Complete care of the critical patient. Assisted in multiple, invasive procedures, code blue team.

1977 - 1981

Doctors Hospital, Coral Gables, FL

Staff Nurse, ICU/CCU

• Complete care of the critical patient. Assisted in multiple, invasive procedures.

Therapeutic Area Experience • Therapeutic areas of Nursing include: ICU/CCU, Neonatal ICU, ENT/Allergy testing, Pediatrics, Medical/Surgical, OB/GYN, Newborn Nursery, GI, and Urology.

• Therapeutic areas of Clinical Research include: CHF, Urology, BPH, Superficial Bladder Ca, Chronic Prostatitis, Overactive Bladder, Community Acquired Pneumonia, Alcohol and Rheumatoid Arthritis, Osteoarthritis, Diabetes, COPD with Type II Diabetes, Diabetic Neuropathy, Alcohol and Opiate Dependency, Fibromyalgia, Insomnia, Pulmonary Hypertension, Congestive Heart Failure, Depression, HTN, and Acne.

• Participated in Phase II through IV clinical trials.

Additional Relevant training Mentor and Field training

Licensure and Certifications: LPN License NYS.# 124284J current

Computer Skills Microsoft Office (MSWord, Excel, Powerpoint) TrakWare, Electronic data Capture, Inform, Impact, Medidata, CTMS, eTMF

Languages English

Contact: 585-***-****

gd5a8n@r.postjobfree.com

Outsourced Sponsors Eli Lilly Cardiovascular Study Phase 3

Wyeth Alzheimer’s and Neurological Phase 3

Alkermese Pediatric Inhaled Insulin Device Phase 3b

Genzyme Genetics Pompe Disease Phase 3

J & J Medication Auditing, Phase 2 and 3

Baxter Cosmetic Surgery Phase 3

Abbott CAP and CPD Phase 3

Solvay Gastroenterology Phase 3

Takeda Hypertension/Cardiovascular/DVT Phase 3

Sanofi/Aventis Anti Nausea/Chemotherapy Phase 2

Pfizer Urinary Phase 3

Merck Alcohol and Opiate Dependency Phase 3

Novartis Oncology Phase 3 Unblinded Drug Accountability Phase 3

Experience with: CT, MRI monitoring, Halter monitors, EKG application and reading, medication device deliverance, training sites in specific medication delivery systems (sprays(surgical) and inhaled)

Experiences vary in monitoring for inpatient and outpatient studies. Clinics, Clinical office settings and University settings, local hospital, and University hospitals.

I am experience in Study Start up. I have experience in Qualification, Initiation, monitoring and Closeout Visits.

Mentored new CRA’s while at Covance.

I have traveled up to 75% on a given project.

Managed up to 4 protocols with sub-protocols at a given time.

Recently completed 1 week training for Global GCP and ICH, San Francisco, CA October 2010

Territories included but not limited to Northeast, Southeast and Midwest such as Ohio and Illinois

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