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Summary

Mirza A. Askar, MD, MPH is an expert clinical research professional with over 25 years experience as a clinician and research associate across India, UK and USA. He has a permanent medical license from Hyderabad Medical Council, India. He is skilled in investigator and patient recruitment and protocol case report maintenance and development, data quality assurance and regulatory body procedures, and GCP and ICH Guidelines. His wide range therapeutic experience includes such indications as oncology, rheumatology, cardiology, neurology, pulmonary medicine and critical care medical intensive care). His post-secondary education was in medicine, resulting in Medical Doctorate (from India). He has also earned a Masters in Public Health, majoring in Health Policy and Administration (SPH, UIC, IL). Mirza A. Askar holds a current medical license of the Hyderabad Medical Council, India. He has attended several CME courses. He actively participates and lectures on major clinical topics. Specialties: Rheumatology Oncology

Experiences

Past Experience

  • Senior Clinical Research Associate
    December 2012 --- June 2013
    • Monitor and manage investigator sites, with particular ability to manage complex studies in advanced therapeutic areas. • Administer protocol and related study training to assigned sites and liaise with sites to manage ongoing project expectations and issues. • Recommend processes to Clinical Management in order to optimize the use of project resources. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Act as a mentor for new clinical staff and provide assistance as required to the Project Team Lead. • Assist colleagues with site visits and site calls, when needed. • Serve as resource to team members with protocol, source documents, electronic clinical data capture, regulatory, data entry, and query resolution questions and issues.

  • Principal Clinical Research Associate
    July 2012 --- December 2012
    • Monitor investigator sites, with particular ability to manage complex studies and/or challenging sites, to ensure the accuracy and validity of CRF entries • Recommend processes to Clinical Management that optimize the use of project resources • Provide mentoring and support to less experienced members of the project team and advice on training and quality issues. • Assist colleagues with site visits and site calls, when needed • Serve as resource to team members with protocol, source document, CTMS, regulatory, data entry, and query resolution questions and issues • Assisted sponsor, study sites, and CRAs with audit preparation/responses and quality issues

  • Medical Manager/Associate Medical Director
    April 2012 --- June 2012
    • Medical/causality assessment of adverse drug reaction reports • Contribution in preparation of narrative summaries fro Periodic Safety Update Reports • National Safety Officer, U.S. • Participation in all Corporate Management Review Board – Expert Circle Meetings • Literature and Information review to ensure the monitoring and evaluation of clinical and safety data • Responsible for overall analysis of adverse drug reaction case reports, prepared by Drug Safety Scientists, prior to FDA submission • Contributes to signal detection and evaluation • Contributes to the preparation of departmental Standard Operating Procedures • Participates in all Regulatory Authority Inspections • Acts as a medical information resource for all other company departments

  • Senior Clinical Research Associate
    April 2009 --- March 2012
    • Provide monitoring visits and site management for a variety of protocols that are complex and/or require knowledge in advanced therapeutic areas • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Team Lead (CTL) and/or line manager • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation • Act as a mentor for new clinical staff and may provide assistance to the CTL as designated.

  • Senior Clinical Research Associate
    December 2007 --- April 2009
    Took on the highest level of responsibility in the role as a Clinical Research Associate (eg routinely represented monitoring function at bid defense, participated in process improvement initiatives, and provided training/mentoring to other CRAs) Quality and adherence to SOPs, Guidelines and all appropriate regulations Investigator evaluation and selection Site Initiation and training On-site monitoring to verify that the rights and well-being of human subjects are protected; that reported trial data are accurate, complete and verifiable from source documents; and that trials are conducted in compliance with the currently approved protocol Investigator site closure

  • Senior Clinical Research Associate
    August 2007 --- December 2007
    Monitored clinical sites Assured clinical sites are conducting research according to Federal (GCP) regulations Interacted with clinical investigators regarding conduct of trials Processed data queries Interacted with company and/or contractor personnel (data entry specialists, statisticians, medical monitors) and clinical investigators in the development and resolution of data queries Processed regulatory documentation Requested and reviewed regulatory documentation required for the initiation of a clinical trial Reviewed and updated existing clinical files Maintained orderly and accurate files on clinical investigators Identified clinical sites and trained site personnel in conducting clinical trials Acted as a liaison between the sponsor and investigator sites and Audit CRO study sites for sponsored studies

  • Senior Clinical Research Associate
    February 2006 --- August 2007
    Completed project activities associated with monitoring functions of Phase 1 - 4 clinical research studies while developing an understanding of the drug development process, Good Clinical Practices, and relevant regulations Provided clinical and technical support for CRA I and administrative staff Managed study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures (PSOPs) May assume the role of a Lead CRA on projects by providing direction and guidance to the project team, coordinating all monitoring activities and communicating the status of these activities to the study Project Leader

  • Clinical Research Associate (CRA)
    November 2004 --- February 2006
    Conducted pre-study, initiation, routine monitoring and close-out visits Recruited investigators Processed regulatory and investigator documentation Developed protocols, case report forms (CRFs), and monitoring conventions Presented at investigator meetings Prepared status reports for clients and company management Reviewed CRFs and other study data in-house Assisted in preparing clinical reports

  • Research Coordinator
    September 2003 --- September 2004
    Reviewed new protocols to evaluate complexity and feasibility Identified site developmental involvement in studies prior to protocol initiation, prepared and submitted IRB applications, attended IRB meetings, and coordinated communications with regulatory authorities Identified prospective candidates by screening patient records, databases and physician referral summaries Maintained enrollment in protocols and provided documentation of screening, enrollment and follow up activities Coordinated collection of data according to the research protocol, reported AE and SAE events and maintained records, and participated in investigator meetings UIC Division of Reproductive Endocrinology and Infertility (REI), Department of OB/GYN

  • Senior Project Coordinator
    February 2002 --- August 2002
    Coordinated multiple projects Managed NIH grant applications, REI fellowship application process, and literature review Edited and compiled research papers for the principal investigator Hines VA Hospital (C.A.R.E.S.

  • Research Associate
    February 2001 --- August 2001
    Recruited and promoted to participation in phase 2 - 3 trials Participated in institutional journal club and clinical meetings Developed CRFs and study questionnaire forms Performed drug accountability activities and participated in summary writing

  • Optometry/Ophthalmology Assistant
    February 2000 --- September 2000
    Performed pre-screening of patients

  • Chief Physician/Director
    April 1997 --- April 1999
    Served as Chief Medical Officer of the out patient clinic at Prince Sultan Air base Responsible for setting up clinical protocols and the budgeting of medical center expenses, and functioned as a liaison with referral centers

  • Chief Physician
    November 1994 --- March 1997
    Provided medical care to intensive care unit patients, and coordinated clinico-pathological meetings of junior doctors

  • Registrar Grade III
    April 1993 --- September 1994
    Conducted research plan designed to analyze and evaluate the manifestations of rheumatoid arthritis (RA) between Asian and Caucasian populations Evaluated, monitored, monitored, and maintained clinical records of patients, and studied the efficacy of tenidap as a non-steroidal anti- inflammatory drug and disease modifying drug in RA comparing two races: Caucasian and Asian Indians in study phases 2 and 3

  • Medical Officer Internal Medicine and Rheumatology
    January 1990 --- March 1993
    • Inpatient and outpatient care of patients of internal medicine • Principal Investigator and co-researcher of clinical research trials; and clinical monitor

Knowledge

LinkedIn Assessment :
In depth knowledge of Microsoft Project 98PC Skills MS Word Excel PP Lotus Inntrax Medidata Inform Fund. of Oncology 17CEUoncologyRheumatologyGCPNeurologyCardiologyCROClinical researchCTMSRegulatory submissions

Education

  • MPH in Health Policy and Administration from School of Public Health, University of Illinois at Chicago in 2003
  • Post Graduate Training in Rheumatology from Guy's Hospital in 1996
  • MD (MBBS) in Medicine from Gandhi Medical College, Osmania University, India in 1988

Training and Certification

  • General Medical Council Certification
  • Permanent Medical License Certification

Area / Region

Bartlett, IL, United States

Others

Driving License
  • No