Serop Gharibian
Costa Mesa,CA
Summary
Versatile and results-driven clinical operations professional with over a decade of experience in medical device research, including start-up environments. Proven expertise across the full clinical trial lifecycle, from feasibility, protocol development (including competitive landscape analysis and endpoint selection), and site identification, through pivotal and registry trials. Skilled in managing all aspects of clinical trial execution—including site monitoring, document management, vendor coordination, and data oversight. Brings hands-on regulatory experience, including drafting FDA Q-submission meeting minutes, managing eSTAR for 510(k) submissions, and overseeing FDA company registration. Adept at navigating cross-functional teams, adapting to evolving priorities, and ensuring regulatory compliance. Recognized for initiative, problem-solving, and clear communication across clinical and regulatory functions.
Overview
20
20
years of professional experience
Work History
Sr. Clinical Research Associate
Vibrato Medical, Inc.
Irvine, CA
04.2023 - Current
- Managed clinical trial protocols and ensured compliance with regulatory standards.
- Coordinated site initiation visits and trained site staff on study procedures.
- Conducted site visits to assess trial progress and data integrity.
- Reviewed and verified case report forms for accuracy and completeness.
- Prepare and submit IRB/Ethics Committee documentation.
- Maintain eTMF and review regulatory binders.
- Create data entry tools for site coordinators and Vibrato data collection personnel.
- Coordinate the clinic visits schedule with the coordinator once a patient is identified.
- Manage the assignment and schedule of device operators for in-home visits.
- Conduct in-home visits.
- Draft NIH reports
- Register studies and submit data on clinicaltrials.gov
Sr. Clinical Research Associate
Axonics, Inc.
12.2021 - 03.2023
- Study management for a registry trial (27 sites, 276 enrolled participants)
- Act as the primary site contact for investigators and research coordinators
- Conduct study training for investigators and research personnel
- Submit central IRB initial submissions, annual continuing reviews, and event reporting
- EDC management
- Review EDC data ongoing basis to ensure to track visit, data entry completion, and identify issues and discrepancies.
- Work with EDC vendor to address issues, conduct UAT for eCRF releases.
- Work with data management team to address aging queries
- Essential document maintenance
- Create templates for essential documents
- Review and edit ICFs for IRB submission and modifications
- Gather essential documents and maintain eTMF currency
- Conduct initial site activations
- Conduct remote interim monitoring visits
- Supervise contract monitor tasks
- Review confirmation and follow-up letters
- Review monitoring report
- Conduct post IMV debriefs with PI and research team to share monitoring observations
- Issue, review, and resolve pending monitor queries
Clinical Research Associate II
Masimo Corporation
Irvine
05.2015 - 11.2021
- Participate in product development teams as a core team member and provide clinical study strategy and guidance
- Manage clinical studies from concept to clinical study report generation to support 510(k) premarket notifications submissions to FDA
- Develop study documents, such as, site study questionnaires, protocol synopsis, clinical trial protocols, informed consent forms, paper and electronic case report forms, investigator brochures, study training material and trial master files (TMF)
- Negotiate contracts with study sites, CROs, and other external vendors based on study budget and monitor existing budgets and invoice payments
- Preform study planning and coordinate logistics to ensure study timelines are met
- Serve as main point of contact with central IRB for site submission and approvals and renewals
- Carry out monitoring visits including: pre-study site selection visits (PSSV), site initiation visits (SIV), interim monitoring visits (IMV), and close out visits (COV)
- Establish and maintain ongoing proactive communication with sites to review study enrollment and associated study metrics, and to identify and resolve problems
- Ensure identification and reporting of safety issues (adverse events, protocol deviations, and device deficiencies) in accordance with good clinical practices (GCP) and FDA regulations
- Conduct data analysis, and perform statistical calculations
- Maintain current and accurate documentation in TMF
- Provide recommendations and input for departmental procedures to improve efficiency and workflow.
Clinical Research Associate
Masimo Corporation
Irvine
05.2013 - 05.2015
- Assessed qualification of sites by reviewing study requirements and conducting pre-study visits and follow-up reports
- Participated in the implementation of clinical studies by training investigators and their staff to ensure compliance with terms and conditions
- Supervised study conduct by liaising with site personnel, and performed site monitoring to ensure compliance with protocols, regulatory requirements, and GCP
- Maintained study documentation by ensuring trial master files and site regulatory binders are current and complete
Clinical Research Specialist
Masimo Corporation
Irvine
05.2010 - 05.2013
- Conducted full range of data collection duties at clinical sites; including equipment set up and operations, execution of study procedures, and data handling
- In-serviced site on data collection techniques with Masimo data collection tools
- Assisted in clinical study design, drafting protocols, ICFs, CRFs, and IRB submissions
- Tabulated data and conducted statistical analyses
- Drafted clinical study abstracts for presentations at scientific and professional conferences
Executive Assistant to CEO
Masimo Corporation
02.2010 - 05.2010
- Acted as a liaison and maintained effective communication among senior executives, board members, shareholders, middle management and administrative staff
- Prepared presentations for executive management reviews and meetings
- Maintained and coordinated CEO daily and travel calendar
- Created and maintained highly effective organizational filing systems, including quick and thorough indexing, resulting in easy access to critical information
Operations Manager, Executive Assistant to CEO
Epinex Diagnostics
09.2005 - 02.2010
- Acted as CEOs point of contact
- Worked alongside investor relations team to reach out to potential investors
- Collaborated with Regulatory Affairs and Marketing Communications Director to manage the dissemination and tabulation of data from a worldwide survey sent to 3000+ endocrinologist, introducing a new diabetes monitoring test
- Collaborated with antibody developers to produce custom antibodies for a diabetes diagnostic test
- Drafted employee handbook and oversaw injury and illness prevention program
- Worked with architects and contractor to design blue prints for a new facility
- Oversaw business relocation to a new facility
Education
Clinical Trials Certificate -
University of California Irvine Extension
Irvine06.2014
Bachelor of Science - Biological Sciences
University of California Irvine
Irvine, CA06.2004
Skills
- Clinical trial management
- EDC management
- Site monitoring
- Budget and contracts management
- Protocol development
- Informed consent forms
- Statistical analysis
- Essential document maintenance
- Effective communication
- Team collaboration
- Problem solving
- Monitoring visits
- Vendor management experience
- Completing regulatory documents
- Clinical study design
- Site management
- ICH-GCP guidelines
- Investigator relations
- Site monitoring expertise
- Conflict resolution
- Trip reports
- Action planning
- ISO guidelines
- Microsoft Office Suite
- Drafting study documents
- Protocols
- ICFs
- CRFs
- Study logs
- IRB submissions
- Site staff training
- Adaptability
- Flexibility
- AE reporting
- Critical thinking
- Feasibility studies
- Electronic data capture systems
- Report writing
- Coordinating site operations
- Study protocols
- Data analysis
- Data collection techniques
Personal Information
Title: Clinical Research Associate
Languages
English
Native/ Bilingual
Arabic
Native/ Bilingual
Armenian
Full Professional
References
References available upon request.
Timeline
Sr. Clinical Research Associate
Vibrato Medical, Inc.
04.2023 - Current
Sr. Clinical Research Associate
Axonics, Inc.
12.2021 - 03.2023
Clinical Research Associate II
Masimo Corporation
05.2015 - 11.2021
Clinical Research Associate
Masimo Corporation
05.2013 - 05.2015
Clinical Research Specialist
Masimo Corporation
05.2010 - 05.2013
Executive Assistant to CEO
Masimo Corporation
02.2010 - 05.2010
Operations Manager, Executive Assistant to CEO
Epinex Diagnostics
09.2005 - 02.2010
Clinical Trials Certificate -
University of California Irvine Extension
Bachelor of Science - Biological Sciences
University of California Irvine
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