Joanne Baldasare has CRA certification with solid knowledge of ICH/GCP, FDA, TPD, EMEA Regulations, and HIPPA. She has over 14 years experience as a Registered Nurse with experiences in nursing instruction, school nurse, long-term care, home health care, supervision, and medical-surgical nursing.
Joanne C. Baldasare, DHSc, CCRA, RN Certified Clinical Research Associate N.Y. 12309•(518) 377-9030•firstname.lastname@example.org __________________________________________________________________________________ JOB OBJECTIVE Seeking a position in clinical research SUMMARY OF QUALIFICATIONS CRA certification with solid knowledge of ICH/GCP, FDA, TPD, EMEA Regulations, and HIPPA. Over 14 years as a Registered Nurse with experiences in nursing instruction, school nurse, long-term care, home health care, supervision, and medical-surgical nursing. Excellent communications skills as a nursing instructor with over 25 presentations and lectures. Proficient in all Microsoft Office applications including SPSS and SAS. Nursing Instructor January 2011-present EXCELSIOR COLLEGE, Albany, N.Y. Teaching baccalaureate prepared nursing students in an online format using Vista software. CLINPROXY RESEARCH SERVICES March 2010-present Ontario, Canada Home-based Clinical Research Associate (Intern) Phase II clinical study of XXXXX drug as a preventative treatment for lowering blood concentrations of low-density lipoprotein cholesterol (LDL-C) in patients with normal and elevated blood concentrations of LDL-C. Performed the following duties in the above project: Identifying potential investigators. Creating research site evaluation forms. Designing case report forms. Preparing randomization schedules for blinded studies. Preparing checklists for study initiation, periodic visits, and study closeout visits Drafting and reviewing informed consent documents and patient information sheets Setting up a trial master file. Classroom and Clinical Nursing Instructor January 2010-January 2011 MILDRED ELLEY COLLEGE, Albany, NY. Instructed practical nursing students in theoretical concepts of science such as basic human needs/rights, legal and ethical requirements, HIPPA regulations, patient education and evaluation, prevention of infection transmission, and communication skills and application of such skills to nursing practice in a structured on-campus laboratory. Teached clinical rotations where students gain “hands-on” nursing experience by giving patient care, teaching and monitoring patient compliance administering medications as well as reviewing drug indications and adverse events. Taught NCLEX-PN prep course with 90 % pass rate. VOLUNTEER EXPERIENCE December 2009 [GLOBAL SERVICE CORPS, Tanzania] Taught English, reading, writing, health, and math to HIV orphans at the Bethlehem Orphanage in KiJenge, Tanzania according to Tanzanian curriculum requirements. Learned how to read and speak basic conversational Swahili in order to better serve and understand residents of Tanzania. OLD ARUSHA CLINIC, ARUSHA, Tanzania Shadowed physicians in diagnosing and treating patient chief complaints according to good clinical practice guidelines; all prescribed medications were fully explained to patients along with assessment of patient understanding. Assisted laboratory personnel with drawing blood specimens for random and fasting blood sugars, performing widal testing utilizing good laboratory practices; Discussion of lab results with patients and course of treatment based on results if necessary in compliance with good laboratory practice. Assisted staff surgeon with primary closure of wounds following standard precautions and adhering to Tanzanian surgical protocols. Entered patient data and became familiar with the DAIICHI hospital computer system while honoring data integrity and patient privacy issues. for typhoid, parasites, and for HIV RESEARCH EXPERIENCE RESEARCHER December 2009 MALARIA RESEARCH STUDY: Applied ICH/GCP in conducting a follow up study determining the prevalence of malaria parasitemia among clients seeking treatment for fever or malaria at drug stores in Tanzania. Performed statistical analyses of data on 293 eligible Tanzanian residents using computer software while securing integrity of all data. Interpretation of statistical analyses indicated that drug store clients, especially children, are as likely to be infected with malaria as patients seeking care for similar illnesses at a health care clinic. HIV CLINICAL RESEARCH PROGRAM, DIVISION OF HIV MEDICINE June 2008-August 2008 ALBANY MEDICAL COLLEGE, Albany, N.Y. Evaluated people with only HIV infection in accordance with inclusion/exclusion criteria. Prepared lab kits and packaged blood specimens on dry ice for shipping in regulatory compliance with specimen protocols. Shadowed senior CRA completing CRF’s. Answered telephones and obtained informed consents of research subjects and/or their guardians adhering to confidentiality regarding trial participants in accordance with ICH/GCP. Reviewed all classes and demonstrated understanding of all classes of HIV drugs which included Nucleotide/Nucleoside Reverse Transcriptase Inhibitors, Non- nucleoside Reverse Transcriptase Inhibitors, Protease Inhibitors, Integrase Inhibitors and Entry Inhibitors and how these drugs disrupt the HIV life cycle. CATHOLIC CHARITIES AIDS SERVICES, SYRINGE EXCHANGE RESEARCH PROJECT Spring Semester 2007 Albany, N.Y. Conducted Internet-based and library research to collect information necessary for program development of a new program such as the Expanded Syringe Access Project (ESAP). Compliance with state regulations/requirements regarding program development was enforced. Prepared tables, graphs, fact sheets, and written reports summarizing search results of HIV incidence and prevalence rates, injection drug use (IDU) and syringe exchange in New York State with strict adherence to issues of confidentiality and regulatory compliance with state protocols. Interpreted research data to executive director of Catholic Charities AIDS program. CLINICAL NURSING EXPERIENCE AND ACHIEVEMENTS September 2007-April 2010 SCHOOL NURSE SCHENECTADY CITY SCHOOL DISTRICT, Schenectady, N.Y. Traveled to various elementary and secondary schools in the Schenectady City School district. Evaluated and managed pediatric health problems including: infectious diseases, allergic conditions, dermatological problems, respiratory, gastrointestinal,musculoskeletal diseases as well as behavioral and mental issues according to school protocols and distr ict stipulations/regulations. Monitored children’s’ medication compliance as well as adverse events associated with medication administration. REGISTERED NURSE/RN SUPERVISOR ACCU CARE HOME HEALTH SERVICES, Rensselaer, N.Y. October 2005-March 2008 Worked as part of an interdisciplinary team which included developing and implementing personalized care plans, making appropriate referrals for various health services, and communicating with physicians regarding patient medication orders, treatments, and inpatient hospitalizations according to good clinical practices. Provided services that were in compliance with regulatory guidelines of the New York State Department of Health and Accu Care Home Health Services. REGISTERED NURSE July 2004-November 2010 NURSECORE, Albany, N.Y. Provided staff relief in hospitals and other health care facilities assuming a variety of roles such as charge nurse, staff nurse, and RN supervision. Became fully compliant with clinical guidelines regarding patient care, confidentiality, medication and treatment administration, lab work results, physician orders, providing progress reports to physicians, maintaining clinical records, and assessing client needs outcome. REGISTERED NURSE October 2001-July 2004 ST. PETER’S HOSPITAL, Department of Addiction Recovery Center (SPARC), Albany, N.Y. Worked on the detoxification unit for alcohol and other substance abuse issue. Observed strict patient confidentiality during hospital stay. Consulted patients on importance of medication compliance and immediately reporting any adverse effects. Encouraged the use of advocacy and support groups where patients receive valuable resources such as self-empowerment and survival tools. SAMUAL STRATTON VA MEDICAL CENTER January 2000-October 2001 Albany, N.Y. Served patients with chronic illnesses such as COPD, Diabetes, Urosepsis and other elimination difficulties in compliance with VA protocol and standards of care. Provided patient education on disease management and prescribed medications along with dosage regimen. JAMES A. HALEY VETERANS HOSPITAL November 1998-December 1999 Tampa, Florida Worked on a medical/surgical unit with oncology focus. Oncology drugs prepared and administered according to NCCN clinical practice in oncology. JAMES A. HALEY VETERAN’S HOSPITAL August 1997-November 1998 Worked on a Spinal Cord Injury Unit utilizing good clinical practices. Performed clinical assessments according to guidelines for the management of acute surgical spine and spinal cord injuries. Contributed substantially to successful JCAHO accreditation within the department. LARGO MEDICAL CENTER December 1996-July 1997 Largo, Florida Worked on medical/surgical unit with telemetry; adhered to clinical guidelines for the management of acute cardiac problems. Prepared patients for surgical and radiological procedures, initiated and maintained intravenous therapy, and operated 12-lead EKG according to hospital standards of care. AREAS OF EXPERTISE: Vista Software, WebCT, ICH/GCP, Ventilator care, Telemetry, Intravenous therapy, Phlebotomy, Basic life support, Addiction medicine/Behavioral Health, Medical/Surgical, Triple Lumen Catheters, Care Plan Administration, Nasogastric (NG)/Sump and Peg Tubes, and Patient /Family education. CERTIFICATION Clinical Research Associate Certification Registered Professional Nurse New York State Chemotherapy Certification 1998-Tampa VA Hospital COMPUTER SKILLS Microsoft Office, SPSS, SAS REFERENCES Available upon request EDUCATION CRA Professional Development Program, Kriger Research Center, Inc. March 2010-June 2010 ICH/GCP Training Clinical Site Monitoring (site selection, initiation, monitoring and close out) Adverse Reporting Pharmacology for Clinical Research Professionals Doctorate in Health Science Dissertation: Development of an Expanded Syringe Access Program in Bangkok, Thailand Concentration Area: Global Health September 2009 NovaSoutheastern University, Fort Lauderdale, FL. Master of Science in School Health Education Health Education Portfolio May 2003 Sage Graduate School, Troy, New York Bachelor of Science in Nursing May 1996 Russell Sage College, Troy, New York Bachelor of Science in Elementary Education (Pre-kindergarten, Kindergarten and Sixth grade) January 1990 St. John’s University, New York, New York
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