Clinical Research Associate
Resume:
Aakriti K. Kainth
San Diego, CA 92122
661-***-**** • *******.******@*****.***
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EDUCATION
University of California, Irvine - Irvine, CA
B.S., Biological Sciences (June 2012)
10-Week CRA and CRC Beginner Program Series – Barnett Educational Services
Certification of Completion
• Completed certification program which gave a comprehensive review of the following areas in clinical research:
o Drug/Device Development
o Roles and Responsibilities of the Clinical Research Team
o Investigator, Site Selection and Budget Neogtiation
o Clinical Protocol Study Elements
o Institutional Review Board, Informed Consent Forms and Privacy of Human Volunteers
o Study Monitoring and Site Initiation
o Adverse Events: Definitions and Reporting Requirements
o Investigational Product Accountability and Study Site Closure
o Compliance and Quality Assurance: Audits and Inspections
o Time Management
RESEARCH EXPERIENCE
Research Assistant, Orange, CA August 2009 – June 2010
UC Irvine Medical Center – Comprehensive Digestive Disease Center Clinic (Coping Study)
• Assisting social worker in explaining to potential study subjects the purpose of our study, and administering the survey to participating subjects.
• Accountable for literary reviews of all articles regarding the study
• Preparing for submission for publication deadline and assisting in writing final paper
Research Student, Orange, CA August 2008- June 2010
UC Irvine Medical Center – Neuropsychiatry Office of Clinical Research
• Accountable for data entry on multiple studies
• Assisted research coordinators with vitals, chart preparation and ECGs.
• Completed other office/clincial tasks as assigned
PROFESSIONAL EXPERIENCE
Clinical Monitor, San Diego, CA June 2011 – Present
UC San Diego, ADCS – Alzheimer's Disease Cooperative Study
• Monitoring various Alzheimer's clinical trials developed by the ADCS
• Travel up to 80%
• Review of Regulatory documents
• Investigational Product accountablility
• Providing re-education and training to clinical research personnel as needed
Clinical Research Coordinator, Orange, CA August 2010 – May 2011
UC Irvine Medical Center – Neuropsychiatry Office of Clinical Research
• Schedule all patient visits and patient transportation
• Submission of all study-related data to its respective database
• Superivsor for Bio 199 research students and High School Medical Forum
• Query resolution
• Maintenance of study regulatory binders, as well as some IRB paperwork
• Taking patient vitals, performing ECG's and all necessary blood draws
• Processing, packing and shipping of all study related laboratory samples
CLINICAL TRIAL EXPERIENCE
• Alzheimer's Disease Neuroimaging Initiative (ADNI, ADNI 2 & ADNI-GO) (ADCS)
• Contrasting the Brain Effects of Risperidal and Invega with fMRI and PET Scanning (Janssen)
• A Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dosage Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 and 200 mg/day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder (Cephalon)
• A Randomized, 6-Week, Double-Blind, Placebo-Controlled, Fixed-Flexible Dose, Parallel-Group Study of Lurasidone for the Treatment of Bipolar I Depression (Dainippon Sumitomo)
• Home Based Assessment (HBA) (ADCS)
• Dominantly Inherited Alzheimer Network (DIAN) (ADCS)
ADDITIONAL INFORMATION
Computer Programs: SPSS, Windows, Microsoft Word, Excel, PowerPoint, and various online data entry systems including Inform, ADCS, Bioclinica, ClinPhone, IWR/IVRS
Languages: Conversational Punjabi/Hindi
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