Vikram Puvenna

 Vikram Puvenna

Vikram Puvenna

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  • Reviews2

Biography

John A. Logan College - Biology


Resume

  • 37030207

    Six Sigma-Yellow Belt

  • 2009

    Vikram V.

    P.

    Cleveland Clinic

    John A. Logan College

    Cleveland Clinic

    GE

    Thomas Jefferson University Hospitals

    Greater Philadelphia Area

    With 8-10 direct reports

    I'm responsible for coordinating

    managing and implementing 35+ Oncology/Non-Oncology clinical trials in Farber Institute of Neurosciences.\nPivotal role in overseeing study feasibility

    identifying and mitigating risks

    budget negotiation and management

    regulatory submissions (local and CIRB)

    resource allocation

    developing Operational policies and procedures

    CAPA plans

    point of contact between Sponsor-CRO/CRA-Site

    and leading a successful team across a matrix environment.\n

    Clinical Research Project Manager

    Thomas Jefferson University Hospitals

    Hyderabad Area

    India

    Process Associate/Developer

    GE

    Cleveland/Akron

    Ohio Area

    After joining the CCF team

    I served as research regulatory liaison between multiple PIs (internal and external)

    sponsoring organizations

    and central research administration on federal

    industry-sponsored program projects.\n\nIn addition to leading all monitoring and quality assessments for the laboratory and research sites

    I trained and mentored medical

    undergraduate

    graduate

    and summer students on GLP

    SOP

    experimental design

    and technologies. \n\nKEY OUTCOMES IN >>>\nPUBLICATIONS & PRESENTATIONS Presented research data at science conferences (Gordon

    AES

    Stroke Congress etc.)

    publishing data in peer-reviewed journals/abstracts.\n\nGRANTS MANAGEMENT Played crucial role in submitting various NIH and industry-funded grants

    totaling approximately $2.5M.\n\nCLINICAL RESEARCH Noted for immense Monitoring and Project Management support on ground breaking Clinical Trial Research on Traumatic Brain Injury in Football players for 3 years.\n\nCOMPLIANCE Identified and resolved compliance issues and concerns

    developing and implementing corrective action plans (CAPA) to mitigate future risk. Assure compliance with internal (Cleveland Clinic -IACUC) and external regulatory agencies such as AAALAC

    USDA

    and DOD.

    Senior Research Technologist/Coordinator ▬ Data Monitoring | Compliance | Education & Mentoring

    Cleveland Clinic

    Caerterville

    IL

    I was recruited to instruct an Anatomy and Physiology course for Associates and Bachelor’s Degree Program. I handled all aspects of course preparation and execution

    delivering formalized lectures on a variety of scientific topics.

    Associate Term Faculty – Anatomy | Physiology

    John A. Logan College

    Cleveland/Akron

    Ohio Area

    I was promoted to serve as Research Coordinator Lead for high-enrolling control

    clinical subjects for primary/secondary brain tumors

    embolic

    or hemorrhagic stroke

    seizure disorders clinical trials in the Neurological Institute. \n\nSupporting the center’s budget of approximately $550K

    I collaborate with primary investigator

    sponsor

    and research staff to evaluate project protocols and recruit subjects. I execute research projects

    ensuring adherence to research protocol requirements and develop data capture and monitoring plans in accordance with GCP timelines. \n\nKEY OUTCOMES IN >>>\nPROJECT MANAGEMENT Serve as Primary Study Coordinator/Liaison for 6-7 IND/IDE trials from start (SIV) to finish (site-closeout). \n\nTRAINING & EDUCATION Invited to serve as a core member of the committee developing education and mentoring curriculum for New Investigators for IND/IDE trials. \n\nPROTOCOL ADHERENCE Serve as key contact between investigators

    research personnel

    internal regulatory (compliance

    IRB

    legal

    ancillary etc.) departments

    CRAs to assist in protocol interpretation

    enrollment

    and safety questions. \n\nQUALITY MANAGEMENT Turned around 3 research trials struggling from lack of quality management and met outlined deliverables within first 4 months on the job. Selected as one of only 16 research coordinators (top 4%)to participate in CCF- Investigator Initiated Clinical Trials Monitoring.

    Clinical Research ▬ Project Management | Quality Assurance | Budget Management

    Cleveland Clinic

    Member

    American Association for Advancement of Sciences

    Associate Member

    International Brain Barriers Society

    Associate Member

    Sigma Xi: The Scientific Research Society

    Member

    The Endocrine Society

    Hindi

    Telugu

    Honors Award in Service

    Noted as a trailblazer in stereotactic surgeries on small animals.

    Cleveland Clinic Foundation

    Honors Award in Excellence

    Acknowledged for participation in key compliance video showcased across the Lerner Institute. The highest honor given by CCF

    I was invited to meet with the President during a special recognition dinner.

    Cleveland Clinic Foundation

    Honors Award in Team Work

    Received Team Work Award for stepping into a challenging role

    revitalizing 3 failing research trials and building a team to meet the strict timeline for completion.

    Cleveland Clinic Foundation

    Honors Award in Innovation

    Recognized within one year of being hired at the Clinic

    I developed a protocol for a POC device supporting real-time (30 minutes) anti-body analysis.

    Cleveland Clinic Foundation

    Honors Award in Service

    Nominated by boss in recognition of outstanding service upon 5-year anniversary with the Clinic.

    Cleveland Clinic Foundation

  • 2006

    University of Miami

    Collaborative Institutional Training and Initiative (CITI Program)

    PhD Coursework in Molecular Cellular Systemic Physiology

    Southern Illinois University

    Carbondale

    Good Clinical Practices (GCP)

    NIDA Clinical Trials Network

    Osmania University

    Bachelor of Science - BS

    Molecular Biology

    Genetics

    Chemistry

    Eastern New Mexico University

    Master of Science - MS

    Cellular and Molecular Biology

    Cleveland Clinic

    Courses in Radiation Safety

    Chemical Hygiene

    and Biological Resource Unit

    Ongoing Professional Development

    National Institute of Neurological Disorders and Stroke (NINDS)

    GCP

  • Pharmaceutical Industry

    Subject Identification

    Budget Administration

    Meeting Facilitation

    Project Management

    Regulatory Compliance

    Clinical Research

    Healthcare Industry

    Cross-functional Collaborations

    Data Analysis & Interpretation

    Quality Assurance

    Research Coordination

    Team Management

    Publications

    Clinical Trial Oversight

    Human Subjects Research

    Database Development

    Human Subject Protection

    CRO

    Public Speaking

    Is phosphorylated tau unique to chronic traumatic encephalopathy? Phosphorylated tau in epileptic brain and chronic traumatic encephalopathy

    Is phosphorylated tau unique to chronic traumatic encephalopathy? Phosphorylated tau in epileptic brain and chronic traumatic encephalopathy

    Expression and functional relevance of UGT1A4 in a cohort of human drug-resistant epileptic brains

    S100B and S100B autoantibody as biomarkers for early detection of brain metastases in lung cancer

    Is peripheral immunity regulated by blood-brain barrier permeability changes?

    Translational Research in Traumatic Brain Injury. Edited by Laskowitz D. & Grant G.

    Chapter 12: \"Biomarkers\" in Translational Research in Traumatic Brain Injury

    Pathophysiological impact of cigarette smoke exposure on the cerebrovascular system with a focus on the blood-brain barrier: expanding the awareness of smoking toxicity in an underappreciated area.

    Levels of S100B in brain and blood of rats with diabetic ketoacidosis

    Blood-brain barrier P450 enzymes and multidrug transporters in drug resistance: a synergistic role in neurological diseases

    Significance of ubiquitin carboxy-terminal hydrolase L1 elevations in athletes after sub-concussive head hits

    Efficacy of anti-inflammatory therapy in a model of acute seizures and in a population of pediatric drug resistant epileptics

    Cellular localization and functional significance of CYP3A4 in the human epileptic brain

    Consequences of repeated blood-brain barrier disruption in football players

    Modulation of peripheral cytotoxic cells and ictogenesis in a model of seizures

    The etiological role of blood-brain barrier dysfunction in seizure disorders

    The Blood-Brain Barrier in Health and Disease

    Volume Two. Edited by Katerina Dorovini-Zis

    Chapter 8: Alterations of the Blood-Brain Barrier in Post-Traumatic Epilepsy

    The role of shear stress in Blood-Brain Barrier endothelial physiology

BIO 205

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