Project Manager Part Time

Therapeutic Experience (Phase I, II, III and IV)

Infections (Skin Infections and Hepatitis B Virus), Metabolic (Weight

Loss), Endocrinology (Diabetes Mellitus Type I & II), Gastrointestinal

(Dyspepsia, Irritable Bowel Syndrome and Constipation (Pediatric and

Adults), Cardiovascular (Hypertension, Left Ventricular Hypertrophy,

Hypertriglyceridemia, & ApoC-III), Women's Health (Hormone Replacement

Therapy, Female Sexual Arousal Disorder, and Menorraghia),

Pulmonary/Respiratory (Cystic Fibrosis, Allergy/Asthma, Upper Respiratory

Infection, COPD, & Pulmonary Hypertension), Rheumatology (Pain Management:

Osteoarthritis and Arthritis), Dermatology (Onychymycosis & Injection Site

Reaction), Ophthalmology (Diabetic Retinopathy & Wet Age-Related Macular

Degeneration), Sedation, CNS (Bipolar Disorder, Schizophrenia, Fragile X

Syndrome, & Autism), Oncology (Lymphoma, Leukemia (CLL), Triple Negative

Breast Cancer & Ovarian Cancer), Orphan Drug, Other (Transthyretin and

Thromboembolic), Factor XI and Wound Care (Venus Ulcers)

Computer Experience

EDC Experience: 7 years of EDC experience: Inform, Data Fax, Clinphone,

eResearch Technology (Expert Data Capture), Medidata, BioClinica, Oracle,

Smart Pen System, Data Labs (Perceptive)and other company specific EDC

systems.

Proficient in the use of the following applications: Microsoft Office

(Word, Excel, & PowerPoint), CTMS, IMPACT, Outlook, and other company

specific applications.

Site Locations

United States and Canada (Montreal & Toronto)

Training

RECIST 1.1

Professional Experience

. Assist in the protocol writing and review process

. To prepare and conduct all site visits including, but not limited to,

qualification visits, initiation visits, monitoring visits,

motivational visits, audit support visits, and termination visits in

compliance with FDA regulations, ICH/GCP guidelines and company SOPs.

. Risked based monitoring experience.

. Assist in identifying potential centers for a proposed study in

conjunction with the Project Team, and conduct feasibility assessment

of sites as required.

. Ensure that investigator site files are assembled appropriately and

that all required documentation is in place prior to release of

clinical supplies

. Overall site management and ensure that all study related

communication including e-mail is tracked, printed and filed as

required.

. Responsible for track patient recruitment by contacting investigators

as specified for the study, and discuss potential study risks and

opportunities with the Project Manager and LCRA.

. Work with local/central laboratories, or other vendors in order to

ensure adherence to the protocol. Responsible for ensuring that all

relevant documentation is current e.g., accreditation certificates,

normal ranges, etc.

. Responsible for updating the investigators financial file, produce a

list for pending investigator payments and produce payment requests.

. To prepare, or facilitate the preparation of Multicenter and/or Local

Ethics Committee / IRB submission documentation as defined by local

requirements. To ensure that EC/IRBs are updated regarding protocol

amendments, SAEs etc.

. Knowledgeable of ICH guidelines, GCP guidelines, and HIPPA regulations

. Provide appropriate support for the preparation,

submission/notification of local regulatory approval if required for

local country requirements.

. Distribute and track clinical trial supplies, e.g. CRFs, study

medication, lab kits and ensure that sites have sufficient supplies to

continue recruitment.

. Track CRFs collected during monitoring visits to data management.

. To liaise with data management regarding data flow and data query

processing.

. Ensure that the interim safety reports are provided to EC/IRBs as per

country requirements.

. Assist the Project Manager in the production of status reports.

. Work in a timely manner in accordance with all the activities

specified in the agreed study budget, under the supervision and

guidance of the Study Project Team.

. Assist in raising invoice requests for investigator payments in

accordance with Investigator/Hospital/Pharmacy agreement terms, to

maintain the site financial tracking, producing a list for pending

investigator payments and producing payment requests,

. Responsible for ensuring that all relevant study documentation is

present for study sites.

. Assist in the development of clinical documents

. To use all reasonable endeavors to work precisely according to

schedules and timelines, established by the Sponsor and Project

Manager for the conduct and completion of the study.

. Developing relationships with 3rd parties and reviewing quality of

services.

. Co-monitoring with CRA's to assess the quality of clinical monitoring

. Pharmacy Monitoring

Sucampo Pharmaceuticals

October 2012 - Present

Senior Clinical Research Associate Consultant- Part Time (Home Based)

Seaside Therapeutics

June 2012 - March 2013

Senior Clinical Research Associate Consultant- Part Time (Home Based)

PRA International

August 2010- December 2010

Senior Clinical Research Associate Consultant-Co-Monitoring Part Time (Home

Based)

Regeneron Pharmaceuticals Inc.

April 2010 - September 2010

Senior Clinical Research Associate Consultant-Part Time (Home Based)

Isis Pharmaceutical Inc.

January 2010 - Present

Clinical Research Associate Consultant & Pharmacy Monitor Consultant- Part

Time

Morphotek, Inc

October 2009 - January 2010

Senior Clinical Research Associate Consultant- Part Time (Home Based)

Research Dynamics Group (Sponsor: Teikoku Pharmaceutical)

June 2009- August 2009

Senior Clinical Research Associate Consultant (Home Based)

ICON Development Solutions

December 2008 -February 2009

Senior Clinical Research Associate Consultant (Home Based)

Inspire Pharmaceutical

January 2008 - September 2008

Clinical Research Associate Consultant (Home Based)

TKL Research, Inc., (Sponsor: Adams Respiratory Therapeutics)

January 2007- July 2007 Senior Clinical

Research Associate Consultant -Part Time (Home Based)

LBR Regulatory & Clinical Consulting Service

September 2006 - October 2007

Senior Clinical Research Associate Consultant- Part Time (Home Based)

Sponsor: Xanodyne Pharmaceutical

GlaxoSmithKline

September 2004 - November 2006

Senior Clinical Research Associate Consultant (Home Based)

PPD (Sponsor: Gilford Pharmaceutical)

August 2004 - March 2005

Clinical Research Associate Consultant (Home Based)

Xylos Corporation

June 2003 - August 2004

Clinical Research Associate Consultant (Home Based)

Novartis Pharmaceuticals

October 2001 - July 2003

Clinical Research Associate Consultant (Home Based)

Eli Lilly Pharmaceutical

June 2000 - September 2001

Clinical Research Associate & Pharmacy Monitor Consultant (Home Based)

Quintiles, Inc.

October 1998 - June 2000

Regional CRA (Home Based)

Penn Center for Rehabilitation and Care

(Formerly New Ralston House)

1996 - 1998

Social Service Director

Planned and directed a comprehensive Social Service Program, which provided

counseling and other support services for patients and families within a

124-bed facility. Coordinated discharge planning, placement, in-service

workshops, education programs, and recreational activities; worked with

multi-disciplinary staff in developing and implementing a behavior

management program; acted as chairman of the following meetings: wound

care, behavior management, family care conference, admissions, and

department head. Maintained written documentation according to state and

federal regulations and facility's SOPs. Submitted administrative reports.

Supervised Admissions Coordinator.

New Ralston House

1995 - 1996

Admissions Coordinator

Marketed the facility's services within the community, hospitals, and

rehabilitation centers. Coordinated daily meeting with multi-disciplinary

team to review potential patients for the facility; reviewed medical

reports and interviewed medical staff and potential patients. Prepared and

submitted written reports to Social service Director and Administrator;

performed other duties requested by Social Service Director.

Education

Bachelor of Science, Psychology 1995

Philadelphia College of Textiles and Science

References available upon request

Contact this candidate