Lucia Amoroso
Westbrook
Summary
Research assistant involved in all aspects of clinical research studies (phases 1-3) in Yale's Psychiatry Department including protocol development, study activation, recruitment, enrollment to study end and data analysis. Works well with cross-functional teams - including internal/ external regulatory bodies, federal agencies, trial sponsors, CROs, and internal Yale teams to minimize regulatory risk. Adept at development, collection and management of regulatory documents for site audits and monitoring visits with continuous adherence to ethical research practices and participant's rights. Serve as a rater, administering clinician-administered assessments for diverse clinical research studies. Accustomed to stepping into different roles and taking on added responsibilities to enable progress and success of groundbreaking clinical research trials in psychiatry.
Overview
15
15
years of professional experience
Work History
Regulatory Research Assistant
Yale University
01.2021 - Current
- Serve as a blinded rater, administering clinician-administered assessments, identifying and reporting adverse events as needed for the study “Effects of repeated dosing of psilocybin on obsessive-compulsive disorder: A randomized, waitlist-controlled study”
- Oversee research databases (Advarra Ereg, Oncore, Redcap, Cirbi, IRES-IRB, Strong Star, paper charts) with utmost diligence, ensuring data integrity and security
- Create and submit modifications and amendments through internal and external IRBs for various clinical research studies
- Leverage strong relationships with regulatory agencies (such as the Yale IRB and external IRBs) for expedited approvals during critical timelines most recently for a phase 3 study evaluating the effects of psilocybin-assisted therapy on major depressive disorder and an open-label proof-of-concept study on individuals with functional impairment due to psychiatric symptoms
- Coordinate responses to inquiries from regulators or other external parties, (trial sponsors, the DEA, CROs, IRBs-both internal and external, YCCI PDDF and PALM teams and other internal Yale entities) ensuring accurate information provided in a timely manner
- Communicate with both the local and federal DEA for addition of study protocols to PI’s schedule 1 license; prepare and submit cover letter, application, and regulatory documents for DEA submission.
- Manage Advarra eReg; upload all IRB documentation and correspondence, all relative employee trainings and licenses, develop and maintain the delegation of authority log, fill out essential forms (financial disclosures, 1572 forms, training attestation documents) and route these for e-signature to staff and the study PI then send to YCCI for study activation
- Communicate with Oncore team to create shell for site activation, review protocol calendar once built and provide comments/troubleshoot with their team then approve release. Upon study activation register subjects, add demographics, eligibility status, treatment arm, and study visit dates to trigger subject e-payments within Oncore. Reimburse participants for travel and meals in addition to standard study payments
- Prepare and maintain document inventory and organize research materials - within aforementioned databases as well as within research lab's OneDrive account site audits and monitoring visits
- Participate actively in regular meetings with fellow researchers to discuss project updates, challenges faced, and lessons learned during ongoing activities
- Maintain up-to-date knowledge of relevant regulations and guidelines, ensuring lab's adherence to requirements throughout protocol completion
- Evaluate internal processes to identify areas for improvement and enhance regulatory compliance by developing and implementing effective policies to maintain data credibility and protect participants' privacy and rights
- Conducted thorough reviews of documentation to ensure alignment with regulatory standards
- Maintain open lines of communication with project leads and team members for effective collaboration on common goals
- Handle on-boarding process for newly hired employees by providing necessary orientation materials and distribution of paperwork
- Streamline on-boarding efficiencies and created new hire orientation materials as well as provided onboarding and training SOPS to new employees
- Troubleshoot with Workday, Advarra Ereg, Oncore support, and other databases to ensure seamless integration of new employees
- Enhance employee morale by developing and executing various employee engagement activities such as organizing gifts for significant life events and holidays
Research Aide/Assistant
Yale University
05.2019 - 01.2021
- Recruit, screen, and manage participant participation within multiple lab studies, more specifically, a study examining glutamatergic deficits for individuals with major depressive disorder, a ketamine clinical trial for treatment resistant PTSD at the VA medical center and structural and functional neural alterations in suicidality among veterans with PTSD
- Conduct psychological assessments and cognitive testing as well as enter progress notes in participant medical records (noting any adverse events as they occur)
- Consent individuals into aforementioned studies by going through lengthy consent forms, checking vital signs, and alcohol levels, ordering labwork, separating all personal health information from de-identified information while following all HIPAA guidelines, and conducting sensitive questionnaires to ensure a smooth and comfortable process for the research participant
- Go through MRI safety with participants and ensure that they are adhering to all rules and regulations for their safety, conduct drug urine tests, pregnancy tests, and then assist in MRI scan by having individuals complete tasks throughout the scan
- Process and store blood samples for future analyses
Medical Secretary/Transcriptionist
Dermatopathology Laboratory of New England
01.2017 - 05.2019
- Collect laboratory specimens and prepare them for lab testing
- Adeptly manage a multi-line phone system and pleasantly greet all patients
- Respond to customer requests via telephone and email
- Copy, log, and scan supporting documentation
- Analyze departmental documents for appropriate distribution and filing
- Maintain strict patient and physician confidentiality
- Transcribe and edit physician reports from dictation
International/Domestic Billing Auditor
Mobility Services International
05.2015 - 09.2016
- Audited domestic and international household good bills
- Articulated audit findings and gave detailed recommendations to upper management to increase profit
- Interacted with vendors to implement audits
- Reduced external audit fees through careful management of resources
- Ensured van lines adhered to billing contracts
- Met with clients to identify and assess business controls, process gaps and workflow inefficiencies
Billing Coordinator
Mobility Services International
11.2013 - 06.2015
- Processed invoices for corporate clients and distributed to expense department
- Processed real estate mortgages and home owners' association fees
- Supervised and coordinated projects for external auditors and examiner evaluations
- Calculated commissions
- Gathered data for internal auditors through financial research
- Reported internal control issues to management and supplied comprehensive recommendations to mitigate the associated risks
Customer Service Representative
Credit Collection Services
01.2013 - 07.2013
- Worked with customers in trying to resolve debt by offering payment plans and settlements
- Consistently brought in top earnings for my team
- Received and processed customer payments
- Resolved disputes and offered solutions to customers' problems
- Developed and maintained an alert system for upcoming deadlines on incoming requests and events
Student Library Assistant
Homer Babbidge Library
07.2009 - 04.2010
- Prepared and packaged books for shipment to various libraries
- Sorted and delivered mail throughout the library
- Opened loading deck for deliveries
- Greeted visitors entering the office and directed them to the appropriate destination
Education
Bachelor of Arts - Communications and History
University of Washington
Tacoma, Washington09.2012
Skills
- Regulatory Document Management
- HIPAA certified
- MRI safety trained
- Complex Problem-Solving
- Cross-Cultural Awareness
- Adept Multi-Tasker
- Data Collection
- Data Entry
- Teamwork and Collaboration
- Research Ethics
- Research Reporting
- Specimen Handling
- Proficient in Yale Databases: Redcap, Oncore, IRES-IRB, Advarra Ereg, Oncore
- Proficient in Additional Databases: ClinicaltrialsGov, CIRBI, Microsoft Office Suite, Adobe Acrobat
Languages
italian
Native or Bilingual
spanish
Limited Working
Timeline
Regulatory Research Assistant
Yale University
01.2021 - Current
Research Aide/Assistant
Yale University
05.2019 - 01.2021
Medical Secretary/Transcriptionist
Dermatopathology Laboratory of New England
01.2017 - 05.2019
International/Domestic Billing Auditor
Mobility Services International
05.2015 - 09.2016
Billing Coordinator
Mobility Services International
11.2013 - 06.2015
Customer Service Representative
Credit Collection Services
01.2013 - 07.2013
Student Library Assistant
Homer Babbidge Library
07.2009 - 04.2010
Bachelor of Arts - Communications and History
University of Washington
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