Christina Tay
Sicklerville,NJ
Summary
Seeking a challenging position as a clinical research professional in a reputable company where I can utilize my medical and clinical trial knowledge and skills.
Diligent Clinical Research Associate/Clinical Trial Manager with robust background in clinical research and trial monitoring. Successfully managed multiple studies, ensuring compliance with protocols and regulatory requirements. Demonstrated proficiency in data analysis and participant coordination, contributing to high-quality research outcomes.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Clinical Trial Manager, Senior Clinical Research Associate
ITM USA
11.2021 - 12.2025
- Responsible for conduct of clinical trials under the Global Clinical Operation
- Support logistics of the trial and CRO coordination and oversight, specifically:
- Support and oversee site activation in US acting as an intermediary between ITM, CRA and site, and providing advice and expert guidance to all
- Support and oversee recruitment in US, helping with identifying contingency plans, looking for additional needs at site level, and liaising with site monitors to ensure importance of our trial is always their focus
- Being Sponsor representative towards the US sites and supporting them for any areas of concern
- Participate in development / co-development, review and approval of trial documentation (trial protocols and amendments, IB, patient consent forms, case report forms, trial manuals and trial tools)
- Conduct Co-Monitoring visits as required for all US sites
- Attend symposiums and meet up with investigators on the status of the clinical trials
- Perform CRA and site assessment based on Co-Monitoring visits and reports, and identify issues with monitoring, with the reasons (insufficient time for CRAs, insufficient support for CRAs, lack of site personnel with necessary training to manage trial activities etc.)
- Oversee and track US CRO Team performance overall
- Support & assist the Global ITM Clinical Operations and Medical team with the smooth running of the studies, with open communication lines established
- Report to the Global ITM Clinical Operations team the progress of US related activities on an ongoing basis
- Oversee communication lines between sites and ESPs such as CRO, Central Labs, etc.
- As a Site Manager for US sites: conducting SSV, SIV, IMV and COV
Global Clinical Trial Manager
Evive Biotechnology (formerly Generon Biotechnology)
10.2020 - 11.2021
- Responsible for conduct of clinical trials under the Global Clinical Operations
- Manage various aspects of the day to day clinical operations of the trials as assigned
- Ensure and maintain clinical development plan timelines for Evive clinical studies
- Oversees performance of ESPs such as CROs, Central Labs, Investigative Drug Manufacturers
- Review budgets and contracts of ESPs and KOLs
- Review investigative brochures and protocols
- Update all Evive clinical studies in ClinicalTrials.gov
- Assist in BLA and EMA submissions
- Assist the Project Director, Chief Medical Officer with additional tasks as assigned
Contract Global Clinical Trial Manager
Janssen Pharmaceuticals Research & Development (a Johnson & Johnson Company)
11.2018 - 10.2020
- Responsible for conduct of clinical trials under the Global Clinical Project Management
- Leads the SMT, drives issue resolutions, and provides updates to all trial team members on the deliverable status
- Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness
- Ensures required reports are generated and available for real time status tracking so the study teams are aware of up to date status of each of their investigative site performance
- Ensures enrollment commitments and actual enrollment meets projected commitments across the regions at the clinical trial level
- Ensures timely and accurate documentation and communication of study progress and issue escalation
- Oversee performance of ESPs such as central labs, IVRS, equipment providers and drug depot to ensure compliance with study protocol and in accordance with scope of work. Identify areas of concern and escalate to GTL. Successfully review ESP invoices to ensure that work is performed in accordance with contract and to save department money.
- Review all assigned investigative site budget/invoices and ensured all subject visit data entry are completed before approving invoices for payment
- Updates study-specific documents such as Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents when necessary
- Provide input into cross functional documents such as Safety related documents, Protocol Deviations and Issue Escalation processes, External Service Provider Oversight Plan, Filing and Archiving Plan
- Ensures trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed
- Act as the primary contact person for the local teams within Global Development
- Establish and maintain excellent working relationships with internal stakeholders, such as country representatives (local trial managers and CRAs), data management leader and clinical supplies' unit
- Successfully demonstrates deep knowledge of protocol and procedures and adequate therapeutic area knowledge
- Ensure compliance with global Health Authority regulations and guidelines and internal operating procedures and processes. Participate in preparation for, and conduct of, Health Authority inspections and internal audits as needed
- (contracted through EASi, LLC)
In-House Clinical Research Associate (acting as Clinical Trial Manager and then Project Manager)
ClinSmart CRO
06.2014 - 11.2018
- Responsible for conduct of clinical trials under the Clinical Operation
- Manage projects under the direction of Project Director as assigned
- Review project progress and adjusted project timelines accordingly.
- Successfully implemented clinical study procedures and strategies.
- Successfully identify and manage investigative sites for each trial
- Work closely with sponsors to estimate project life cycles.
- Determine project schedules and documented progress
- Develop monitoring plan for CRAs
- Review monitoring reports by CRAs
- Provide input in the preparation of clinical protocol, investigator brochure, informed consents, and other documents for clinical trials
- Interview and hire personnel in collaboration with Project Management
- Manage all aspects of Investigative sites including contract/budget negotiations, regulatory document collections, follow the milestones
- Successfully conducted Risk-Based Monitoring (RBM) assigned by sponsors
- As a trial manager, successfully completed site selection and pre-study activities to identify and evaluate potential investigators that truly have the subject population to conduct studies
- Exceeded in monitoring investigative sites to ensure the accuracy and validity of electronic case report forms (eCRF) entries in relation to patient records/clinic notes (source document verification)
- Accomplished in-house monitoring activities as appropriate, such as updating in-house site files, remote monitoring and completing visit reports/ letters
- Develop source document forms for investigative sites
- Ensure proper storage, dispensation and accountability of all investigational products (IP) and trial-related material
- Ensure Investigative Product is supplied only to eligible patients
- Maintain tracking records for assigned sites including tracking of subject status, subject eCRF/source document review, regulatory documents, and investigational product
- Anticipate/identify site issues and implements corrective actions or escalates to study manager/sponsor as necessary
- Manage query resolution process with investigative sites and data management
- Participate in study-specific training
- Increase knowledge of drug development process, therapeutic areas, Good Clinical Practices (GCPs) and any applicable local regulatory requirements
Clinical Research Coordinator
Center for Sleep Medicine Chestnut Hill Hospital
11.2012 - 06.2014
- Responsible for the implementation of clinical research protocols, under the direction of Physician Investigators, including the evaluation of new clinical research protocols and submission of initial regulatory documentation and preparation of IRB applications. Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Submission of protocols to the IRB for approval
- Protocol management and development of phase I (investigator initiated) II and III studies
- Participate in the study development and start-up process including reviewing protocols, reviewing CRFs, preparing informed consent forms, developing study documents with PI, sponsor and CRO
- Submit required initial regulatory documents and preparation of IRB applications with central IRBs
- Manage research studies budget and payments with sponsors
- Facilitate scheduling subjects for research visits and research related procedures. Collects, records and maintains records of all data collected for research participants
- Screen for potential research participants through evaluation of inpatients and outpatients using inclusion/exclusion criteria and protocol-specified eligibility requirements.
- Explain research study to potential participants and obtain informed consent prior to initiation of study related procedures
- Serves as a liaison for ongoing communication between investigators, research participants and their families, research support associates and data specialists for the protocols
- Collaborate with physician investigators to monitor and manage patients’ care on research protocols
- Accurately complete all case report forms and maintain source documents according to HIPAA, study guidelines and SOPs
- Ensure adverse events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary
- Review study documentation for completeness and accuracy; maintain site payment summaries
- Attend investigator meetings and training of study protocol procedures
- Manage visit reports, letters, query resolutions, and site expenses and payments
- Manage investigator site trial master file
- Interact with CRAs to address study and site queries and resolve issue
Clinical Research Coordinator
Temple University School of Podiatric Medicine
10.2010 - 11.2012
- Responsible for the implementation of clinical research protocols, under the direction of Physician Investigators, including the evaluation of new clinical research protocols and submission of initial regulatory documentation and preparation of IRB applications. Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Submission of protocols to the IRB for approval
- Protocol management and development of phase I (investigator initiated) II and III studies
- Participate in the study development and start-up process including reviewing protocols, reviewing CRFs, preparing informed consent forms, developing study documents with PI, sponsor and CRO
- Submit required initial regulatory documents and preparation of IRB applications with central IRBs
- Manage research studies budget and payments with sponsors
- Facilitate scheduling subjects for research visits and research related procedures. Collects, records and maintains records of all data collected for research participants
- Screen for potential research participants through evaluation of inpatients and outpatients using inclusion/exclusion criteria and protocol-specified eligibility requirements.
- Explain research study to potential participants and obtain informed consent prior to initiation of study related procedures
- Serves as a liaison for ongoing communication between investigators, research participants and their families, research support associates and data specialists for the protocols
- Collaborate with physician investigators to monitor and manage patients’ care on research protocols
- Accurately complete all case report forms and maintain source documents according to HIPAA, study guidelines and SOPs
- Ensure adverse events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary
- Review study documentation for completeness and accuracy; maintain site payment summaries
- Attend investigator meetings and training of study protocol procedures
- Manage visit reports, letters, query resolutions, and site expenses and payments
- Manage investigator site trial master file
- Interact with CRAs to address study and site queries and resolve issue
Clinical Research Coordinator
Cooper University Hospital
11.2005 - 08.2010
- Responsible for the implementation of clinical research protocols, under the direction of Physician Investigators, including the evaluation of new clinical research protocols and submission of initial regulatory documentation and preparation of IRB applications. Coordinate and participate in a variety of complex activities involved in the collection, compilation, documentation and analysis of clinical research data. Submission of protocols to the IRB for approval
- Protocol management and development of phase I (investigator initiated) II and III studies
- Participate in the study development and start-up process including reviewing protocols, reviewing CRFs, preparing informed consent forms, developing study documents with PI, sponsor and CRO
- Submit required initial regulatory documents and preparation of IRB applications with central IRBs
- Manage research studies budget and payments with sponsors
- Facilitate scheduling subjects for research visits and research related procedures. Collects, records and maintains records of all data collected for research participants
- Screen for potential research participants through evaluation of inpatients and outpatients using inclusion/exclusion criteria and protocol-specified eligibility requirements.
- Explain research study to potential participants and obtain informed consent prior to initiation of study related procedures
- Serves as a liaison for ongoing communication between investigators, research participants and their families, research support associates and data specialists for the protocols
- Collaborate with physician investigators to monitor and manage patients’ care on research protocols
- Accurately complete all case report forms and maintain source documents according to HIPAA, study guidelines and SOPs
- Ensure adverse events are reported appropriately, accurately and in a timely manner and that follow-up activities are conducted as necessary
- Review study documentation for completeness and accuracy; maintain site payment summaries
- Attend investigator meetings and training of study protocol procedures
- Manage visit reports, letters, query resolutions, and site expenses and payments
- Manage investigator site trial master file
- Interact with CRAs to address study and site queries and resolve issue
Education
Bachelor of Science - Biology
Wagner College
Staten Island, New YorkDoctor of Medicine - undefined
Central America Health Sciences University
Belizeundefined
Ross University School of Medicine
DominicaEducational Commission for Foreign Medical Graduate Certificate - undefined
Skills
- Experience in Microsoft (Word, PowerPoint and Excel)
- Experience in Electronic Data Capturing (InForm, eTrials, Oracle RDC, Target, Bioclinica Express, eCaseLink, eClinicalOs, Medrios, Panther CTMP, Medidata RAVE)
- Experience with Clinical Trial Management System (Medidata) and Experience with eTMF (Veeva Vault)
- Experience with Interactive Response Technologies (IVRS) for Clinical Trials
- Adverse event reporting
- Clinical data management
- Clinical trial oversight
- Patient recruitment
- Document review
- Investigator relations
Certification
- Educational Commission for Foreign Medical Graduate Certificate (ECFMG: US Medical Board certification)
- Barnett International Good Clinical Practice: Practical Application and Implementation
- Barnett International Drug Safety and Pharmacovigilance Certificate
- Barnett International Certificate/Trial Master File Certificate
- The CRA Training Institute Certificate
- Continuing Education in Clinical Trials Certificate with ACRP and SOCRA
- Collaborative Institutional Training Initiative certification (CITI)
- National Institutes of Health (NIH) Office of Extramural Research Certificate
- How to Conduct Clinical Trials
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Clinical Trial Manager, Senior Clinical Research Associate
ITM USA
11.2021 - 12.2025
Global Clinical Trial Manager
Evive Biotechnology (formerly Generon Biotechnology)
10.2020 - 11.2021
Contract Global Clinical Trial Manager
Janssen Pharmaceuticals Research & Development (a Johnson & Johnson Company)
11.2018 - 10.2020
In-House Clinical Research Associate (acting as Clinical Trial Manager and then Project Manager)
ClinSmart CRO
06.2014 - 11.2018
Clinical Research Coordinator
Center for Sleep Medicine Chestnut Hill Hospital
11.2012 - 06.2014
Clinical Research Coordinator
Temple University School of Podiatric Medicine
10.2010 - 11.2012
Clinical Research Coordinator
Cooper University Hospital
11.2005 - 08.2010
Doctor of Medicine - undefined
Central America Health Sciences University
undefined
Ross University School of Medicine
Educational Commission for Foreign Medical Graduate Certificate - undefined
Bachelor of Science - Biology
Wagner College
CAREER HIGHLIGHTS
- Twenty years of experience as a clinical research professional providing clinical document and study supports
- As clinical trial project manager, received praise and bonus from sponsor for successfully achieving the targeted enrollment of randomized subjects on time as defined in the protocol
- As a clinical trial manager, managed external service providers (CROs, Laboratories) and global investigative sites
- Responsible for 2 study trials and 30 investigative sites as project manager
- Both study subject recruitment successfully completed 2 months ahead of schedule
- In-depth knowledge of GCP/ICH/FDA regulations
- Perform site selection and pre-study activities to identify and evaluate potential investigators and successfully chosen sites that truly have the subject population
- Perform on-site, remote monitoring and risk-based monitoring activities from study start-up to close-out
- Extensive range of experience including protocol management and completing regulatory documents
- Experience working with phase II, III and IV clinical trials in various therapeutic areas such as Nuclear Medicine/Oncology, Hematology, Cardiology, Critical Care Medicine, Neurology, Podiatry, Dermatology, Dentistry, Psychiatry, Respiratory, Hepatology and Infectious Disease (COVID19)
- Responsible for accuracy and integrity of data collected on source documents and electronic data capture
- Assigned up to 14 sites on 2 protocols as lead clinical research associate
- Perform study-related tasks with minimal or no oversight
- Thrive in both independent and collaborative work environment
- Highly detail-oriented, with superior record retention and time management skills
- Responsible for multiple studies at the same time and prioritize to meet datelines
- Technologically savvy and proficient in the use of multiple systems including Electronic Data Capture, Clinical Trial Management System and Interactive Response System
- Medical background including medical degree and ECFMG (US Medical Board) certification