Amy Santiago
Miramar, ,FL
Summary
Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
21
21
years of professional experience
1
1
Certification
Work History
Clinical Research Associate
ICON/Pfizer FSP
Durham, North Carolina
08.2021 - 02.2022
- Responsible for investigator site management and monitoring for assigned sites
- Provide input into and/or develop study related materials such as protocols, Clinical Monitoring Plans, Data Management Plans, eCRF forms, data completions guidelines, patient diaries, recruitment plans, and patient informed consents
- Ensure proper conduct of clinical trials in accordance with the Monitoring Plan and applicable prevailing laws, Good Clinical Practices, and Pfizer standards to achieve project goals, timelines, and quality
- Manage assigned operational aspects for implementation of clinical trial activities at assigned investigator sites from study start-up through database lock, ensuring relevant timelines and quality deliverables are met
- Identify, evaluate, and select investigator sites as needed-
- Interface with the study team as needed, facilitate information flow between members of the study team and assigned investigator sites
- Perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks- applicable for general GCP compliance; protocol specific issues to be escalated to study team
- Conduct site initiation visits in collaboration with study team members as needed
- Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators
- Partner with study team to define and support recruitment initiatives at site level- applicable
- Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring and study site closure visits and ensure these are conducted accordance to Monitoring Plan, SOPs and commensurate with emerging issues and technologies
- Monitor site level AEs and SAEs and collaborate with the Drug Safety Unit and follow-up with investigators sites, as needed, to bring SAE reports required information to resolution-
- Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigator and site personnel to close open issues and to prevent recurrence/persistence of issues
- Resolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out visit within required timelines
- Maintain thorough understanding of the product, protocol, and therapy area in sufficient details to have appropriate discussions with the investigator and site team- applicable
- Interact with investigator site heath care professionals in a manner which enhances Pfizer’s credibility, scientific leadership and to facilitate Pfizer’s clinical development goals-
- Support the study team in following up with investigators regarding the ongoing evaluation of subjects- applicable for general guidance; protocol specific issues to be escalated
- In partnership with appropriate study team members contribute to the study level risk plan; mitigate for known/anticipated risks proactively-
- Monitor site performance using appropriate tools and resources (e.g., metrics, site health, Risk Based Monitoring signals, etc.) and take appropriate targeted action-
- Apply knowledge of data and analytics to target site level actions for mitigation and control- applicable
- Proactively identify, manage, and escalate site issues
- Identify and address Significant Quality Events or other quality issues at patient and/or site level- applicable
- In collaboration with appropriate study team members, create and implement corrective actions and preventative actions (CAPA) as needed-
- Ensure resolution of investigator site issues to maintain sound investigator relations-
- Communicate with investigators, study coordinators and other site staff on a regular basis to build and maintain productive relationships and support investigator engagement through medical and scientific discussion
Clinical Research Associate
IQVIA/ROCHE FSP
Durham, North Carolina
10.2020 - 08.2021
- Accountable and primary contact for the study sites
- Lead with site-level perspective through a clear and thorough understanding of site processes
- Perform continuous, risk-based, remote monitoring, using the tools and support available
- Support the site in the compliance with Sponsor deliverables and timelines according to business requirements and project expectations
- Support the site to improve quality of source data collection and entry, increase compliance and improve processes and procedures / minimizing protocol deviations
- Perform site selection, initiation, routine, and close-out visits in accordance with the contracted scope of work and good clinical practice
- Support sites to develop, drive, track, and adapt subject recruitment in line with project needs and with enhanced predictability
Clinical Research Associate, Consultant
Plethora Solutions
Rosemont, PA
03.2020 - 10.2020
- Identifying, evaluating, and establishing trial sites, and closing sites down on completion of trial
- Training site staff on therapeutic areas, protocol requirements, proper source documentation and case report form completion
- Liaise with ethics committee regarding rights, safety, and well-being of trial subjects
- Ordering, tracking, and managing IP and trial materials
- Overseeing and documenting IP dispensing, inventory, and reconciliation
- Protecting subjects’ confidentiality, updating their information, and verifying IP has been dispensed and administered according to protocol
- Conducting regular site visits, coordinating project meetings, and writing visit reports
- Implementing action plans for sites not meeting expectations
- Liaising with regulatory authorities
- Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines
Clinical Operations Assistant Manager
Suncoast Research Group, LLC
Miami, FL
10.2017 - 09.2019
- I work closely with the Clinical Operations Manager, Site Director, and Principal Investigators to coordinate all research activities on-site, while ensuring protocol adherence and patient safety
- Serve and assist as the liaison between the Site and the Sponsor and FDA representatives
- Ability to multi-task and manage several projects in parallel, paying attention to detail
- Ensure that all clinical research duties are performed according to protocols, sponsor's guidelines, GCP & ICH guidelines, as well as local and FDA regulations
- Assist with Hiring and training of all clinical department staff
- Team building and conflict resolution within the clinical team
- Assist the Clinical Operations Manager in the process of seeking, vetting, managing and training all vendors associated with the site
- Identify project issues such as resource, technical or scheduling constraints, and assist to resolve issues internally and externally by performing risk assessments and developing summarized options and proposed solutions
- Ensure that projects are completed on time, within budget and scope, and conform to pre-established quality standards
- Primary contact to all the IRBs, CROs, Sponsors and Study Vendors
- Assist during Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close Out Visits
- Assist during Sponsor Audits and FDA Inspections
- Create GCP compliant source documents and review all documents related to clinical trials
- Collect and distribute site metrics for internal departmental meetings and for the site's Business Development department
- CTMS training and implementation
- Management of site calendar
- Organizes and manages internal team meetings, investigator meetings and other trial-specific meetings
Senior Clinical Research Coordinator
Suncoast Research Group, LLC
Miami, FL
04.2010 - 10.2017
- A Phase II-IV Outpatient Facility
- Responsible for recruiting, screening, and enrolling study participants, obtaining informed consent
- Prior to study participation, scheduling and performing study activities, developing study source documents, study product dispensation and accountability, completing
- Source documents and case report forms (CRFs, eCRFs), communication with study sponsors and other sites on study status, issuing subject payment
- Collect, process, and store biological specimens
- Assists physician with procedures and exams when needed
- Maintain all required materials at appropriate inventory levels such as lab kits and supplies
- Perform basic statistical computations of "raw data' such as: mean, standard deviation, and
- Standard errors
- Understanding of proper quality control procedures, use of control materials, and documentation
- Of QC results and corrective action
- Knowledge of ongoing quality assurance activities
- Provided preceptorship for newly hired assistant study coordinators in training, served as back up
- Study coordinator for over fifteen additional clinical trials
Clinical Research Coordinator
University Clinical Research
Pembroke Pines, FL
01.2009 - 04.2010
- University Clinical Research A Phase II-IV Outpatient Facility
- Responsible for recruiting, screening, and enrolling study participants, obtaining informed consent
- Prior to study participation, scheduling and performing study activities, developing study source
- Documents, study product dispensation and accountability, completing source documents and
- Case report forms (CRFs), communication with study sponsors and other sites on study status,
- Issuing subject payment
Screening Coordinator
Cetero Research International
Miami, FL
09.2007 - 01.2009
- A Phase I-IV inpatient/outpatient facility
- Responsible for in person screening of potential subjects for participation in clinical trials, the
- Management of medical files, obtaining consent, providing potential subjects with study overview,
- Collection of clinical diagnostic samples, and performing all protocol required tests for
- Inclusion/exclusion, communication with study sponsors and other sites on study status.
Screening Coordinator, Supervisor
SFBC International
Miami, FL
12.1998 - 01.2006
- Responsible for management of entering screening data for all studies, supervision of staff
- Members involved in screening potential participants, preparation, and organization of entering
- Study specific inclusion/exclusion criteria into the site-specific data system called "ABC",
- Communication with study sponsors and other sites on study status
- Successfully led key projects which resulted in positive outcome
Education
Bachelor of Science - Nursing
Florida International Association of Phlebotomy Technicians, Holmes Braddock Senior High School
CITI GCP Certified - undefined
Universidad Sagrado Del Corazon
Skills
- Skills and Qualifications:
- ECG, Telemetry, and Vital Signs
- Phlebotomy
- Clinical Trial Management Systems (eg Clinical Conductor, Clinasyst)
- Microsoft Office (Word, Excel, PowerPoint, and Outlook)
- Electronic Data Capture Systems (eg, Oracle, InForm, Medidata, iDataFax)
- Interactive Voice/Web Response Systems (eg, IMPALA, ClinPhone
- Signature: ________________________________________ Date: ________________
- Wwwqpscom
- VerJUL2020 Amy Santiago Page 2 of 2
- SRA Trials, LLC
Certification
Annual OSHA Training
BLS for Health Care Providers (CPR & AED)
IATA Certified
CCRC Accreditation
CITI Human Subject Research Protections
CITI Information Privacy & Security - Health Privacy Track
Languages
English
Full Professional
Spanish
Full Professional
Timeline
Clinical Research Associate
ICON/Pfizer FSP
08.2021 - 02.2022
Clinical Research Associate
IQVIA/ROCHE FSP
10.2020 - 08.2021
Clinical Research Associate, Consultant
Plethora Solutions
03.2020 - 10.2020
Clinical Operations Assistant Manager
Suncoast Research Group, LLC
10.2017 - 09.2019
Senior Clinical Research Coordinator
Suncoast Research Group, LLC
04.2010 - 10.2017
Clinical Research Coordinator
University Clinical Research
01.2009 - 04.2010
Screening Coordinator
Cetero Research International
09.2007 - 01.2009
Screening Coordinator, Supervisor
SFBC International
12.1998 - 01.2006
Bachelor of Science - Nursing
Florida International Association of Phlebotomy Technicians, Holmes Braddock Senior High School
CITI GCP Certified - undefined
Universidad Sagrado Del Corazon
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