Michelle Zadourian

Michelle Zadourian

$25/hr
Regulatory Affairs, Clinical Research, Administrative
Reply rate:
-
Availability:
Part-time (20 hrs/wk)
Age:
28 years old
Location:
Los Angeles, California, United States
Experience:
5 years
MZ Michelle Zadourian Chatsworth, CA 91311 -- PROFESSIONAL SUMMARY SKILLS WORK HISTORY Hardworking and focused assistant and student offering excellent communication, planning and prioritization skills demonstrated through years of performance and education. Knowledge of APA, HIPAA, and ethical guidelines as well as implementing them in writings and overall work. Organized and dedicated professional with self-motivated work ethic to perform effectively in independent or team environments. Strong Interpersonal Skills Research Quality Control Procedures Research and Analytical Skills Statistical Data Analysis Multitasking and Time Management Strong Organizational Skills Document and File Management Clerical Support Regulatory Documentation Multivariate Analysis CLINICAL RESEARCH COORDINATOR/REGULATORY 02/2022 to CURRENT AFFAIRS MANAGER Empire Clinical Research | Pomona, CA Worked with governance committees to make and evaluate plans. Performed and documented quality control checks to maintain compliance with company initiatives. Prepared and maintained document inventory for core dossier preparation in collaboration with the central and local IRB. Maintained energy and enthusiasm in fast-paced environment. Managed multiple studies simultaneously. Represented company in research industry during communications with global regulatory agencies. Prioritized project-related tasks to efficiently complete essential tasks. Worked with internal team members to accomplish regulatory goals and achieve full compliance with all products. Analyzed field studies and reports, compiled information and submitted concise and informative summaries. Trained staff in regulatory policies or procedures. Directed documentation efforts to comply with domestic and international regulations and standards. Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols. Collected data and followed research protocols, operations manuals and case report form requirements. Maintained compliance with protocols covering patient care and clinical trial operations. Screened patient records, databases and physician referrals to identify prospective candidates for research studies. Participated in initiation visits and investigator meetings, implementing trials in accordance with study timelines and budgets. Followed informed consent processes and maintained records. Coordinated clinical trials focused on disorders such as depression and ADHD. Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity. REGULATORY ASSISTANT/RESEARCH ASSISTANT 09/2018 to 05/2019 Nihon Kohden America | Irvine, CA Summarized search results by preparing written reports, graphs, fact sheets and tables. Assisted in FDA approval documents and records to ensure product quality. Organized research notes and analyzed qualitative data. Managed phone and email correspondence and handled incoming and outgoing mail and faxes. Assisted coworkers and staff members with special tasks on daily basis. Managed filing system, entered data and completed other clerical tasks. Interacted with vendors, contractors and professional services personnel to receive orders, direct activities and communicate instructions. Maintained daily reports and advised executive leaders in decision-making processes. Conducted meetings to discuss new improvements in products. AUTHORIZATIONS REPRESENTATIVE 04/2016 to 05/2018 Center For Autism And Related Disorders, Inc | Woodland Hills, CA Gathered records pertinent to specific problems, reviewed for completeness and accuracy and attached records to correspondence as necessary. Maintained files and controlled records to show correspondence activities. Communicated with executives about consistent customer issues. Read incoming correspondence to ascertain nature of writers' concerns and to determine disposition of correspondence. Assisted multiple departments including Compliance, Authorizations, and Customer Service to help streamline efficiency. Completed form letters in response to requests or problems identified by correspondence. Managed all overdue authorizations and resolved issues within the department to help run things more smoothly. Maintained HIPAA laws and regulations. Maintained energy and enthusiasm in fast-paced environment. EDUCATION Bachelor of Arts | Psychology 12/2021 California State University - Northridge, Northridge, CA Dean's List Spring 2021 and Fall 2020 3.7 GPA Research Project: The effects of DSM IV categorized mental illnesses, severity of illnesses, and coping strategies on perception of personal characteristics. Results indicated that there was a significant main effect for both mental illness and coping strategies, but no significant main effect was found for severity. Research Project: The effects of gender and gender-toy stereotyping on toy preference. Results showed Gender-Toy Stereotyping was implied, whereby girls really wanted to play with girl toys and boys had absolutely no desire to play with boy toys. However, there was no significant difference in Toy Preference for Gender. Research Project: The effects of distraction via smartphone notification sounds on working memory. Results showed that there was no significant difference between the ringtone and vibration groups against the silent group on working memory. LANGUAGES Armenian Spanish Native or Bilingual Limited Working
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