Experience

Advanced Clinical

• United States
• Biotechnology Research
• 700 & Above Employee

• Patient operational specialist

  • Jun 2019 - Aug 2020

  NJ  Reviews information contained in donor files to ensure compliance with all applicable FDA and International regulations as well as AATB standards.  Utilizes clinical knowledge of acute/clinical events to identify missing or ambiguous donor information to facilitate a comprehensive review of donor files.  Responsible for the triage and review of information received after initial donor release to assess the potential impact on donor suitability and distributed products, triggering… Show more  Reviews information contained in donor files to ensure compliance with all applicable FDA and International regulations as well as AATB standards.  Utilizes clinical knowledge of acute/clinical events to identify missing or ambiguous donor information to facilitate a comprehensive review of donor files.  Responsible for the triage and review of information received after initial donor release to assess the potential impact on donor suitability and distributed products, triggering escalation procedures, and evaluation for regulatory action.  Collaborated with the CAPA team throughout all phases of the CAPA process from initiation, investigation, action, effectiveness, risk management, and use of root cause analysis tools.  Performs retrospective reviews as required to assist with audits and investigations as requested, including external audits of human tissue products.  Identify areas for improvements as related to donor file review and donor review metrics and implements change. Show less



Yochana IT Solutions INC

• United States
• Business Consulting and Services
• 200 - 300 Employee

• Consultant- Clinical Evaluation Report Evaluator

  • Jun 2018 - Jun 2020

  NY  Utilize understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.  Assessed and Evaluated routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria) for specific medical devices  Served as the… Show more  Utilize understanding of scientific and research methodology, medical device regulations and guidelines, and product knowledge, to support Regulatory Affairs submissions for CE Marking of new devices and maintaining of CE Mark for existing devices in accordance with MEDDEV 2.7/1 Rev 4, MDD, AIMDD, and EU MDR 2017/745.  Assessed and Evaluated routine systematic literature reviews (e.g. screens articles against inclusion/exclusion criteria) for specific medical devices  Served as the therapeutic area expert on assigned CER projects, collaborating with the internal team to meet all project deliverable timelines  Collaborated with cross-functional teams to provide clinical expertise during the preparation of CER within agreed-upon timelines.  Maintain current knowledge of product portfolio and safety profiles for products across therapeutic areas applicable to global medical device regulations and standards.  Conducts proofreading, editing, document formatting, review comment integration, and document completion/approval activities.  Acquires or possesses in-depth knowledge of competitor devices, state-of-the-art, current clinical/market developments, literature review processes, and the ability to keep abreast of current literature. Show less



RWJBarnabas Health

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Lead transplant research coordinator

  • Jan 2017 - Jul 2018

  Livingston, New Jersey Led all aspects of Phase 1 – Phase 4 trials from start to finish, including patient recruitment, data entry, patient monitoring, working with doctors, and pharmaceutical company collaboration.  Executed and supervised more than 15 clinical research studies  Organized and conducted monthly research meetings and trainings  Supervised seven research and nursing staff, ensuring training, performance management, and career development  Participated in Emerging Leadership training on… Show more Led all aspects of Phase 1 – Phase 4 trials from start to finish, including patient recruitment, data entry, patient monitoring, working with doctors, and pharmaceutical company collaboration.  Executed and supervised more than 15 clinical research studies  Organized and conducted monthly research meetings and trainings  Supervised seven research and nursing staff, ensuring training, performance management, and career development  Participated in Emerging Leadership training on principles and implementations of visionary leadership, as well as audits conducted by sponsors and United States Food and Drug Administration (FDA)

• Research Coordinator

  • Feb 2014 - Dec 2016

  Livingston, New Jersey Assisted with conducting trials in a timely and accurate manner in accordance with FDA, ICH, and GCP guidelines. Involved in the success of Phase 1 – Phase 4 trials, including collection, compilation, documentation, and analysis of clinical research data.  Ensured accuracy and patient confidentiality with consistent, secure, and precise documentation  Processed all documentation with the Institutional Review Board (IRB), including submissions, continuing reviews, amendments, and adverse… Show more Assisted with conducting trials in a timely and accurate manner in accordance with FDA, ICH, and GCP guidelines. Involved in the success of Phase 1 – Phase 4 trials, including collection, compilation, documentation, and analysis of clinical research data.  Ensured accuracy and patient confidentiality with consistent, secure, and precise documentation  Processed all documentation with the Institutional Review Board (IRB), including submissions, continuing reviews, amendments, and adverse event reporting



DaVita Kidney Care

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Registered Nurse, Dialysis Unit

  • 2007 - 2017

  Performed assessment and data collection, focusing on physiologic, psychosocial, cultural, spiritual, and cognitive status, as well as nutrition, pain, patient/family education, family involvement, and patient advocacy. • Formulated a plan of care prioritized and based on determined nursing diagnosis and patient outcomes • Performed duties of a charge nurse for the facility in addition to providing regular patient care



Saint Peter's University

• United States
• Higher Education

• Registered Nurse, Metabolic Unit

  • 2012 - 2013

  Jersey City, New Jerssey Initiated and developed patient plan of care based on patient assessment and medical diagnosis while setting priorities for nursing action in accordance with unit’s turnaround policy. • Provided comprehensive care according to state regulations, hospital policy, and Joint Commission standards • Determined patient needs upon admission and on an ongoing basis while responding appropriately



INGHAM REGIONAL MEDICAL CENTER

• United States
• Hospitals and Health Care
• 1 - 100 Employee

• Registered Nurse, Med-Surg/Tele

  • 2006 - 2007

  Maintained full accountability for interpreting EKG data and responding to patients’ urgent medical needs. • Conducted comprehensive reviews and assessments to support stroke individuals and their families • Educated and provided care to medical patients including pre-operations, recovery, and discharge teaching • Performed tasks independently, including diagnosing patients, and providing critical assistance to physicians • Contributed as an active member of a multidisciplinary… Show more Maintained full accountability for interpreting EKG data and responding to patients’ urgent medical needs. • Conducted comprehensive reviews and assessments to support stroke individuals and their families • Educated and provided care to medical patients including pre-operations, recovery, and discharge teaching • Performed tasks independently, including diagnosing patients, and providing critical assistance to physicians • Contributed as an active member of a multidisciplinary team to coordinate stroke care Show less