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A dynamic Experienced Clinical Research professional, with over 20 years of experience supporting the Pharmaceutical/Biotech, CRO, and Medical Device industries.Summary of Experience Includes:20 years’ experience of clinical research site monitoring and management of Phase I-IV trials, four years experience in direct staff management and extensive experience in site management and business development, and 3 years experience in FDA GCP site auditing, utilizing GCP/ICH guidelines.Therapeutic Experience:Oncology, Cardiology, Endocrinology, CNS/Neurology, GI, Infectious Disease (Herpes, HPV, Chlamydia, AIDS), Vaccines, Musculoskeletal, Dermatology, Women's Health & Device, Cardiovascular Hypertension, Dermatology, Psoriasis, Medical Device, Asthma, Cardiovascular Stents, Pediatric Autism, ADHD, Bipolar Disorder, Depression, Pediatric Schizophrenia, Alzheimer’s Disease, Epilepsy (Adult and Pediatric), Respiratory, Asthma, COPD, Rheumatology, Gout, Osteoporosis, Crohn’s Disease, Transplant, Renal Failure End-Stage Renal Disease, Ophthalmology, Cancer Pain Management, Acute Lymphoblastic Leukemia, Gene therapy, Hemophilia B, Hereditary Angioedema
Pantheon Clinical Research
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Pantheon Clinical ResearchSalt Lake City, Ut, Us -
Sr. CraVanguard Clinical, Inc. Feb 2022 - PresentSan Diego, Ca, UsConducts CRA Routine Assessment Visits of junior CRAs• Participates in training / mentoring of staff with new changes • Is subject matter expert on clinical studies or therapeutic areas• Excellent communicator both verbally and written- Conduct regular monitoring visits. -
Principal Clinical Research AssociateCti Clinical Trial And Consulting Services Sep 2017 - Jul 2021Covington, Ky, Us• Conducts CRA Routine Assessment Visits of junior CRAs• Participates in training / mentoring of staff with new changes • Is subject matter expert on clinical studies or therapeutic areas• Excellent communicator both verbally and written• Expert in International Council for Harmonisation (ICH) / Good Clinical Practice (GCP), local country regulations, and CTI policies/procedures; is a resource to others on regulatory issues. • Proficient in Clinical Trial Management System (CTMS), Metadata, Inform, Risk-Based Monitoring, and electronic data capture (EDC), InForm, Medidata, Clin Plus, Oracleo Therapeutic areas: Diabetes Mellitus, Pompe Disease, Delayed Graft Function in Recipients of a Deceased Donor Kidney (Rare kidney Disease), Autologous Arteriovenous Fistula in Subjects with End-Stage Renal Disease -
Senior Regional Clinical Research AssociateIndependent Consultant 2014 - 2017Performed regional monitoring services for:• KPS (Ocugen), Senior Clinical Research Associate, 2016-2018o Therapeutic areas: Ophthalmology, Genetic Rare disease • InVentiv Health, Senior Clinical Research Associate, 2016-2017o Therapeutic areas: Ophthalmology • Boehringer Ingelheim, Senior Clinical Research Associate, 2015-2016o Therapeutic areas: Dermatology • PAREXEL International, Senior Clinical Research Associate, 2014-2015o Therapeutic areas: Hypertension (HTN), Pain Management, Attention-Deficit / Hyperactivity Disorder (ADHD) adult studies• INC Research, Regional Senior Clinical Research Associate, 2015-2016o Therapeutic areas: Ophthalmology
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Lead Regional Site ManagerForest Laboratories (Now Allergan) 2012 - 2014Us• Managed all aspects of Pediatric Autism clinical trial at all assigned clinical sites to ensure patient safety and adherence to appropriate safety regulations and data integrity.• Performed clinical monitoring activities, which included the review of case report forms (CRFs) to ensure adherence to protocol and consistency and scientific validity of data.• Assisted in generating and reviewing source documents and CRF guidelines.• Managed query resolution process with sites and data management.• Prepared for and conducted on-site QSVs, SIVs, MVs, and COVs to Investigator sites.• Prepared for and attended project launch meetings.• Assisted in preparing and developing materials for Investigator Meeting; attended Investigator Meeting as designated by Project Manager.• Demonstrated proficiency in the following systems: Siebel, Clinical Trial Management System (CTMS), Metadata, Inform, Risk-Based Monitoring, and electronic data capture (EDC).• Authored Guidelines for Monitoring Pediatric Clinical Trials for monitoring pediatric and adolescent studies in order to promote consistency across all studies.o Therapeutic areas: Pediatric Autism -
Senior Regional Clinical Research AssociateIndependent Consultant 2011 - 2012Performed regional monitoring services for:• Novartis Pharmaceuticals, Lead Clinical Research Associate, 2011-2012o Therapeutic areas: Phase II and III human papillomaviruses (HPV) adult study and Phase III Psoriasis trials.
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Lead Clinical Research AssociateTakeda 2007 - 2011Tokyo, Jp• Managed six CRAs and monitored 15 sites and 6 different protocols for phase II and III for several HTN, cardiovascular, and pain management adult studies.• Responsible for conducting field training visits with CRAs. Trained and mentored new CRAs and reviewed and approved monitoring reports.o Therapeutic areas: Hypertension, Cardiovascular, and Pain Management -
Senior Regional Clinical Research AssociateIndependent Consultant 2002 - 2007Performed regional monitoring services for:• MedFocus, Senior Clinical Research Associate, 2005-2007o Therapeutic areas: HPV adult study and pediatrics vaccine• Lilly Pharmaceutical, Clinical Research Associate, 2004-2005o Therapeutic areas: Phase IV CNS (ADHD, bipolar disorder, and depression; epilepsy, schizophrenia)• Astra Zeneca, Senior Clinical Research Associate, 2003-2004o Therapeutic areas: Phase II pediatric Crohn’s Disease and Phase II Psoriasis• Johnson & Johnson Pharmaceuticals, Project Manager, 2003-2004o Therapeutic areas: Cardiovascular Stents• Advance Research Corporation, Senior Clinical Research Associate, 2003-2004o Therapeutic areas: Depression, Epilepsy, and Schizophrenia.• NPS Pharmaceutical, Regional Clinical Research Manager, 2002-2002 o Therapeutic areas: Postmenopausal Osteoporosis
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Regional Clinical AuditorFda 1999 - 2003Silver Spring, Md, UsPerformed GCP site audits across multiple therapeutic areas for the FDA. -
Regional Clinical Research AssociateCovance 1997 - 1999Princeton, New Jersey, Us• Monitored the conduct of clinical trials for treating severe peripheral occlusive disease (PAOD), unstable coronary syndromes, asthma, vaginal ring, infectious diseases, and asthma in the pediatric population.• Drafted case report forms (CRFs) and protocol amendments for hepatitis and human immunodeficiency virus (HIV) phase II trial.• Reviewed CRFs, source documents, and informed consent forms (ICFs). • Advised clinical staff on protocol adherence and trial conduct.• Ensured clinical trial material accountability and completeness of regulatory documents.• Conducted start-up and IMVs for global phase II and III trials for unstable coronary syndrome, with over 4000 patients worldwide.• Interviewed and selected investigative researchers for study participation, in addition to developing and distributing study instruction material protocols and CRFs. o Therapeutic areas: Peripheral Occlusive Disease (PAOD), Unstable Coronary Syndromes, Asthma, Vaginal Ring, and Infectious Diseases. -
Regional Clinical Research AssociateIqvia 1995 - 1997Durham, North Carolina, Us• Monitored the conduct of clinical trials for CNS (depression, bipolar, schizophrenia, epilepsy).• Prepared site reports and correspondence, assisted in preparing reports to sponsoring pharmaceutical companies.• Responsible for data clarification with Investigator staff, and answered protocol-related questions from study sites.• Project experience includes 2 large phase III trials for Alzheimer's disease each with a total of over 1500 subjects.• Presented protocols during Investigator Meetings.• Provided instrumental education and training of research staff during study initiation as well as tracked and managed enrollment growth.• Conducted study close-out for a nationwide phase III trial for peripheral arterial disease (PAD).o Therapeutic areas: Depression, Bipolar, Schizophrenia, Epilepsy
Mari Livermore Skills
Mari Livermore Education Details
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Ada Gobetti MarchesiniBiochemistry
Frequently Asked Questions about Mari Livermore
What company does Mari Livermore work for?
Mari Livermore works for Pantheon Clinical Research
What is Mari Livermore's role at the current company?
Mari Livermore's current role is Regional Clinical Research Professional | Independent Consultant | On-Site & Remote Monitoring Specialist.
What is Mari Livermore's email address?
Mari Livermore's email address is ml****@****eda.com
What is Mari Livermore's direct phone number?
Mari Livermore's direct phone number is +180145*****
What schools did Mari Livermore attend?
Mari Livermore attended Ada Gobetti Marchesini.
What skills is Mari Livermore known for?
Mari Livermore has skills like Ctms, Clinical Trials, Edc.
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