Registered Nurse Manager
Resume:
Patricia Bruszewski, RN, CCRC, CCRA
Lancaster, PA 17601
************@*****.***
EXPERIENCE
September 2010 to Current - PharmaNet Resource Solutions
*** ******ie Center
Princeton, NJ 08540
Contract Clinical Research Associate (Home based)
June 01, 2011 to Current - Contract position to monitor the clinical trial process for a Phase II Carotid Stenosis study. This study involved MRI assessments and the use of PharmaNet's electronic data capture system (WebSys).
September 17, 2010 to February 18, 2011 - I accepted a contract position to monitor the clinical trial process for a long term study involving the subcutaneous administration of a biologic in patients with Osteoarthritis. This study involved the use of electronic data capture using Oracle RDC.
Responsibilities:
• Conduct Interim Monitoring visits. Review source documents, electronic e-case report forms, regulatory documents, informed consents, investigational product and clinical supply accountability. Ensure all adverse events have been documented and reported according to FDA regulations and sponsor protocols. Provide feedback and training to site personnel as needed.
• Conduct Close-Out visits. Retrieve and reconcile all study supplies. Archive study documentation and prepare the clinical site for any potential audit.
• Produce timely and comprehensive visit and status reports.
January 2008 to September 2010 – Omnicare Clinical Research
630 Allendale Road
King of Prussia, PA 19408
Clinical Research Associate II: (Home based)
June 2009 – September 2010: Monitor the clinical trial process for three separate phase II dose-ranging studies for Rheumatoid Arthritis. There are two core studies involving IV and subcutaneous administration of a biologic and an open-label extension study involving subcutaneous administration of biologic. The study involved the use of Phase Forward’s InForm electronic data capture.
Responsibilities:
• Conduct Interim Monitoring visits. Review source documents, electronic e-case report forms, regulatory documents, informed consents, investigational product and clinical supply accountability. Ensure all adverse events have been documented and reported according to FDA regulations and sponsor protocols. Provide feedback and training to site personnel as needed.
• Conduct Close-Out visits. Retrieve and reconcile all study supplies. Archive study documentation and prepare the clinical site for any potential audit.
• Produce timely and comprehensive visit and status reports.
January 2008 – June 2009: Performed on-site monitoring for a phase IV safety study involving bimonthly administration of a biologic for Psoriasis.
Responsibilities:
• Perform comprehensive site management activities and consultative services to site personnel by coordinating and disseminating all pertinent data regarding study protocols, case report forms, and FDA/ICH GCP guidelines.
• Conduct Pre-Study Monitoring visits. Review study plans and clinical investigators and evaluate clinical sites to ensure that they meet all study parameters and all FDA and GCP guidelines.
• Conduct Site Initiation visits. Review and explain study protocols with clinical investigators and clinical site staff. Serves as a consultant to site personnel on all sponsor-related SOPs and regulatory requirements.
• Conduct Interim Monitoring visits. Review source documents, paper and electronic e-case report forms, regulatory documents, informed consents, investigational product and clinical supply accountability. Ensure all adverse events have been documented and reported according to FDA regulations and sponsor protocols. Provide feedback and training to site personnel as needed.
• Conduct Close-Out visits. Retrieve and reconcile all study supplies. Archive study documentation and prepare the clinical site for any potential audit.
• Produce timely and comprehensive visit and status reports.
June 1999 to May 2007 - Klein & Associates, M.D., P.A.
Osteoporosis and Clinical Trials Center
921 Seton Drive, Suite C & D 346/348 Mill Street
Cumberland, MD 21502 Hagerstown, MD 21740
Klein & Associates is a private rheumatology practice of Steven J. Klein, M.D., F.A.C.R., C.C.D. The practice includes The Osteoporosis and Clinical Trials Center, which offers comprehensive osteoporosis care, as well as phase II, III, and IV clinical trials. My responsibilities were as both a Senior Clinical Research Coordinator and Office Manager for the Cumberland Office.
Senior Clinical Research Coordinator: Coordinated study activities from initiation to completion for Phase II, III, and IV clinical trials. All studies were conducted following GCP, the study protocol and SOPs. Therapeutic experience included Rheumatoid Arthritis, Osteoarthritis, Osteoporosis, and Systemic Lupus Erythematosus.
Responsibilities:
• Assisted in determining site eligibility for clinical trials and actively participated in study initiation meetings.
• Developed many research-related documents such as SOPs and source documents. Developed a source document template which was recognized by CROs and sponsors as valuable, as evidenced by requests that the template be made available to other research sites.
• Prepared and maintained regulatory documents.
• Collaborated with the physicians to develop recruitment strategies for our very rural research site. These strategies proved very successful and led to the site being the highest enrolling site for several studies. I was asked by a sponsor to share these recruitment strategies with other sites at an investigator meeting.
• Maintained effective and essential verbal and written communication with subjects, sponsors, CROs, IRBs and local health care institutions/providers.
• Coordinated all aspects of subject study visits including obtaining the informed consent, determining study eligibility, reviewing medical history, performing protocol-required procedures such as vital signs/measurements, joint assessments, ECGs, and laboratory assessments including collection of PK/PD; evaluating subject compliance with oral medications and protocol requirements, and performing safety and adverse event monitoring and reporting. Completed case report forms and electronic data capture.
• Collaborated with and directed local health care providers in performing study-related procedures such as laboratory tests, gynecological assessments, endoscopies and radiographic assessments.
• Established office IV infusion suite. Developed infusion-related SOPs and equipped the suite with emergency medical equipment and medications. Administered IV and oral medication to study subjects.
• Oriented and mentored all new research staff, provided leadership and guidance on all site study-related activities, and served as the clinical trial liaison between the Cumberland and Hagerstown offices.
• Provided education to patients and subjects. Educational topics included general rheumatology disease states and medications, study-related procedures and subject responsibilities, and medication administration including self-injections and injection devices.
Office Manager: In addition to my responsibilities as Senior Research Coordinator, I was the Office Manager accountable for day to day operations of the practice.
Responsibilities:
• Provided overall leadership to the private practice and research staff.
• Facilitated and led monthly office meetings.
• Assisted Dr. Klein with interviewing and hiring new employees.
• Provided training and monitored performance of all new office staff.
• Developed SOPs for the on-site lab. Maintained laboratory certifications and I.A.T.A. certifications for employees shipping hazardous material. Responsible for all quality control of lab and office equipment.
Jan 1995/June 1999 - Western Maryland Health System/Sacred Heart Hospital
902 Seton Drive
Cumberland, MD 21502
Registered Nurse: Provided care for a varied population of patients on a busy Telemetry/Medical-Surgical Unit.
Responsibilities:
• Provided close monitoring of adults with acute and chronic disease which included
cardiac arrhythmias, hypertension, congestive heart failure and diabetes mellitus.
• Monitored patients pre and post cardiac catherization and pacemaker insertion
• Experience with arterial, central and PICC lines.
• Assisted patients with special skin care needs including ostomy care.
• Monitored post-surgical care of patients
• Worked collaboratively with surgeons, cardiologists and interns to achieve optimum
patient care.
Extended Roles:
• Assumed the responsibility of Charge Nurse for a 24 bed unit
• Member of the following committees: Congestive Heart Failure Pathway committee, Medical Records Review Committee, Physician, Nurse & Administrative Liaison Committee and Patient Education Committee
• Preceptor for senior nursing students
Sept 1977 – May 1981 - Louis Cohen & Son
9 Fellows Avenue
Wilkes-Barre, PA 18706
Accounts Receivable Manager
Responsibilities: Managed accounts receivable and payroll.
EDUCATION
1994 Associate of Science Degree in Nursing - Magna Cum Laude
Allegany College of Maryland
Cumberland, MD
1977 Associate of Applied Science Degree in Secretarial Science
State University of New York at Morrisville
Morrisville, NY
TRAINING
June 2006 The Research Landscape: Navigating Successfully
Baltimore/Washington Chapter ACRP Educational Program
May 2005 The Research Challenge – Putting The Pieces Together
Baltimore/Chesapeake Bay Chapter ACRP Educational Program
April 2003 Guidelines for HIPAA
ACRP – Philadelphia, PA
Oct.2002 Bristol Myers-Squibb, San Diego, CA
Standardized Joint Assessment Training
Oct. 2001 Centocor, Charleston, WV
IV Administration/Certification
Oct. 2000 Knoll , La Jolla, CA
Assessing Disease Activity in Rheumatoid Arthritis
Joint Assessment Training
Jan 14-24, CRA Training Course – Omnicare Clinical Research
2008 East Greenbush, NY
LICENSURE & CERTIFICATIONS
2011 – Present Certified Clinical Research Associate (ACRP)
2001 – Present Certified Clinical Research Coordinator (ACRP)
1994 – Present Registered Nurse – Licensed in Maryland and Pennsylvania
MEMBERSHIPS AND ACTIVITIES
Member of Association of Clinical Research Professionals since 1999
Member of Baltimore Chapter of Association of Clinical Research Professionals since 2002
References available on request
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