Clinical Research Project Manager

FURQAN HAQ CURRICULUM VITAE

**** ***** ***** ******, *******, FL 32771 • Phone: 904-***-**** • ac1cgp@r.postjobfree.com

EDUCATION

MSPharm, Pharmaceutical & Regulatory Science, University of Florida, Gainesville, FL, Spr 2016

MPH, Biostatistics & Epidemiology, University of Florida, Gainesville, FL, Fall 2012

MBA, Executive MBA, University of Florida, Gainesville, FL, Spr 2010

PhD, Bioengineering, Minor: Nanotechnology & biology, University of Georgia, Athens, GA, Fall 2005

PDE, Professional Development Engineering degree, University of Wisconsin-Madison, WI, Spr 2005

MS, Engineering, West Virginia University, Morgantown, WV, Fall 1999

BA Regents, Biomedical Science, West Virginia University, Morgantown, WV, Fall 1997

PROFESSIONAL EXPERIENCE

Director of Clinical Research, April 2015 – Current

THEVAX Genetics Vaccine USA Inc., Cape Canaveral, FL (Greater Orlando Area)

Achievements: Managing trial specialists, data managers, biostatistician, CROs and regulatory scientists

Worked on: Vaccines, infectious diseases (cervical/anal dysplasia, HBV), and cervical/anal cancer

Managing all aspects of drug development including assessing operational feasibility

Preparing study protocols, investigator brochures, SOPs, CRFs, INDs, NDAs and BLAs

Tracking and monitoring research studies, research investigators, ethical review board decisions

Designing training programs, protocols, CRFs, AE reporting, and pharmacovigilance for trials

Assuring proper conduct and timely completion of studies through effective project management

Monitoring study safety/efficacy by reviewing data and consulting with scientific advisory board

Reviewing monitoring plans, lab manuals, patient diaries, procedures manuals, and drug manuals

Writing medical reports, efficacy/safety summaries, scientific rationales, and benefit/risk ratios

Interacting with study medical director, regulatory affairs, investigators, CROs, and vendors

Research Director, July 2014-April 2015

Spinal Research Foundation/Virginia Spine Institute, Reston, VA (Washington D. C. Metropolitan Area)

Achievements: Facilitating the growth of research conducted by SRF’s research partners across the nation

Worked on: Spine, medical devices, robotic spine surgery, pain medicine, and physical therapy

Leading the coordination/execution of clinical trial management activities across multiple studies

Budgeting and contract negotiations for industry-sponsored and non-industry sponsored studies

Managing work of research staff to meet the organization’s goals, priorities, and objectives

Developing/maintaining collaborative research partnerships to further mission of the organization

Providing leadership and management of research staff on all research operations and programs

Analyzing scientific data and information for publications, conferences, education and outreach

Program Director, January 2014-June 2014

Louisiana Public Health Institute/ Louisiana Clinical Data Research Network, New Orleans, LA

Achievements: Leading operations and administration of network and alignment of the partner institute

Responsibilities: Ensuring supervision of staff, information systems, work plans, regulatory, and finances

Worked on: Clinical data registry & EDC; obesity, diabetes, oncology, and public health initiatives

Directing the design/development of multi-site clinical trials and a central clinical data repository

Leading an initiative to have the health institute function as a CRO for efficient study operations

Managing the project budget and overseeing all study expenditures to meet project finances

Organizing timely preparation of reports for executives, partner institutions and key stakeholders

Administrating task forces, patient and clinician boards for consensus-driven decision-making

Research Director, October 2012 – December 2013

North Florida Dermatology Associates, P.A., Jacksonville, FL

Achievements: In 1st Year achieved record revenue, streamlined workflow, and increased studies by 200%,

Responsibilities: Regulatory and compliance, patient visits, study management, and coordinator workflow

Worked on: Biologics, drugs and medical device in dermatology, rheumatology and reconstructive surgery

Managing complex clinical information to improve the research workflow of clinical researchers

Ensuring compliance of clinical trial protocol and providing oversight of study-related activities

Recording patient’s AEs/SAEs, lab reports, medical history, and concomitant medications

Designing, implementing and reporting of clinical studies and support of regulatory submissions

Monitoring safety reports and plans; preparing Investigator Brochure and; designing CRF

Implementing good clinical practices, FDA and EMEA/CHMP regulations and guidelines

Program Director/Project Manager, May 2010 - September 2012

National Institutes of Health (NIH) Sponsored Research Centers in Minority Institutions, Los Angeles, CA

Achievements: Project manager for NIH sponsored clinical research centers at 18 research institutions

Worked on: Cardiovascular, infectious diseases, oncology, obesity, health disparities and clinical data sets

Ensuring compliance of specific regulatory related processes with FDA and NIH regulations

Developing progress reports for NIH, regulatory documents, and protocols for clinical studies

Reviewing clinical research activities, GANTT charts, SOPs, grant proposals, and manuscripts

Designing, coordinating, managing, and executing multi-site national clinical research and trials

Monitoring HIPAA/human subjects protection training, IACUC approval, and IRB submissions

Updating clinical trial teams, CRFs, data-analysis, severe adverse reactions, and clinical protocols

Program Director on Department of Education grant to promote STEM education in high schools

Research Scientist/Lab Manager, Orthopedics and Sports medicine, August 2007- April 2010

Biomechanics and Muscle Injury Laboratories, Ohio State University Medical Center, Columbus, OH

Achievements: Coordinated a team of 7-8 doctors, engineers, biostatisticians, and medical students

Worked on: Orthopedics/sports medicine, biomarkers, osteoarthritis, clinical data sets, and bioinformatics

Developing and writing trial protocols and presenting it to a steering committee;

Documenting for approval, informed consent, recruitment materials, and data collection forms

Coordinating with the ethics committee and safeguarding wellbeing of all trial subjects

Coordinating administrative, IRB and IACUC approval of proposed research protocols

Reviewing journals, abstracts and scientific literature to stay ahead of new clinical developments

Setting up the study centers including ensuring each center has the trial materials and training

Research Scientist, Cardiothoracic Surgery/Cardiovascular, January 2006 – July 2007

Pediatric Cardiac Surgery Laboratory, Stanford University Medical Center, Stanford, CA

Achievements: Coordinated a team of 7-8 surgeons, biochemists, engineers, and surgery residents

Worked on: Cardiovascular, medical devices, regenerative medicine/stem cells, and clinical data sets

Managing clinical research/education programs in cardiothoracic and cardiovascular department

Reviewing scientific publications, continuing medical education, and surgery laboratory protocols

Performing statistical design and data analysis, epidemiology, and informatics in clinical research

Updating clinical/laboratory data, personnel, equipment, technology, and other research resources

Developing clinical models for studying complex cardiac heart-valve disease state and conditions

Research Assistant, August 2001- December 2005

Driftmier Engineering Center, University of Georgia, Athens, GA

Worked on: Tissue engineering, biomechanics, nanotechnology, biotechnology, stem cells and statistics

Investigating complex issues in tissue engineering and embryonic stem cell-derived progenitors

Characterizing molecules, cells, and biomaterials using cell imaging and ultrastructure methods

Designing/developing bioreactors, nano-biosensors, BioMEMS, microfluidics, and nanoparticles

Reviewing scientific publications, engineering projects, and nanotechnology laboratory protocols

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