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