Summary
Overview
Work History
Education
Skills
Clinical Rater Experience
Technical Experience
Certification
Accomplishments
References
Timeline
Generic

Kristianna Maldonado

Staten Island,NY

Summary

Proficient Clinical Research Site Manager with a strong foundation as a Clinical Research Coordinator, experienced in overseeing both interventional and observational clinical trials. Recognized for excellence in project management, safety oversight, and strategic problem-solving, consistently delivering successful trial outcomes, and fostering collaborative research environments. Known for high productivity and efficiency, with a demonstrated ability to meet deadlines, ensure regulatory compliance, and lead cross-functional teams. Strong communicator and adaptable leader, with a focus on maintaining operational excellence and promoting team cohesion in dynamic clinical settings.

Overview

7
7
years of professional experience
1
1
Certification

Work History

Site Manager

Tekton Research
Marlboro, NJ
01.2025 - 06.2025
  • Review and discuss awarded studies with the Principal Investigator to assist Tekton Leaders in making informed decisions about which studies to conduct.
  • Effectively managing day-to-day site activities for the optimization of site performance.
  • Ensure that site staff are qualified and trained for their roles and duties.
  • Acquire and maintain the following Tekton training: Tekton Research, Inc. SOPs, processes, and policies – every year, or as changes are made.
  • Maintained equipment and tools to ensure operational readiness and efficiency.
  • Communicate with others involved in the study, such as vendors, the recruiting department, and other resources as needed.
  • Facilitated team meetings to discuss project status, challenges, and strategies for improvement.
  • Work with regulatory staff to manage essential documents.
  • Managed daily operations of the research site, ensuring compliance with protocols and safety standards.
  • Facilitated communication between departments to streamline workflow processes.

Clinical Research Coordinator III

Holy Name Medical Center
Teaneck, New Jersey
07.2024 - 12.2024
  • Skillfully coordinate and oversee numerous subject visits each day, ensuring strict compliance with study protocols and regulatory requirements.
  • Managed participant recruitment and maintained accurate enrollment records.
  • Maintained study documentation in compliance with institutional policies.
  • Assisted in monitoring data integrity and ensured proper reporting practices.
  • Reviewed medical records for accuracy of source documentation prior to database lock.
  • Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
  • Conducted quality assurance audits at research sites to ensure adherence to protocols, SOPs, FDA regulations, and guidelines.
  • Collaborating with Principal Investigators (PIs) and Sub-Investigators (Sub-Is) to manage various aspects of clinical research oversight. This includes reporting adverse events (AEs) and serious adverse events (SAEs), evaluating inclusion and exclusion criteria, conducting detailed safety reporting on vital signs, blood parameters, and ECG tracings, thoroughly reviewing medical records and history, and ensuring proper management of study drugs for individual subjects.
  • Performing venipuncture for blood sample collection, administering and interpreting Electrocardiograms (ECGs), and accurately measuring vital signs, while strictly following established protocols.
  • Creating study-specific source documentation in line with protocol requirements and regulatory standards to ensure thorough and accurate recording of clinical research data.
  • Handling Institutional Review Board (IRB) submissions and overseeing the precise management of electronic filings.

Senior Clinical Research Coordinator/Site Supervisor

Richmond Behavioral Associates
Staten Island, New York
01.2021 - 06.2024
  • Overseeing a multitude of various clinical trials simultaneously, often managing more than 20 trials concurrently as a primary coordinator.
  • Conducting venipuncture procedures for blood sample collection, administering and interpreting electrocardiograms (ECGs), and obtaining vital signs with precision and adherence to established protocols.
  • Engaging in collaborative efforts with Principal Investigators (PIs) and Sub-Investigators (Sub-Is) to address various facets of clinical research oversight, including adverse event (AE) and serious adverse event (SAE) reporting, assessment of inclusion and exclusion criteria, meticulous safety reporting encompassing vital signs, blood parameters, and ECG tracings, comprehensive review of medical records and history, and ensuring accountable management of subject-specific study drugs.
  • Ensuring thorough site preparedness for both internal and external audits, to uphold compliance with regulatory standards, and to facilitate seamless examination of clinical research processes and documentation.
  • Providing comprehensive support and training to newly onboarded coordinators, facilitating their seamless integration into the team, and ensuring a thorough understanding of protocols, procedures, and best practices within the clinical research environment.
  • Developing and constructing study-specific source documentation per protocol requirements and regulatory standards to ensure the comprehensive and accurate recording of clinical research data.
  • Facilitating Institutional Review Board (IRB) submissions and managing the meticulous filing of electronic and paper documents to ensure compliance with regulatory standards and ethical considerations.
  • Trained and supervised junior staff in research protocols and procedures.
  • Organized study meetings and facilitated communication among team members.
  • Served as a liaison between sponsors, investigators, and vendors throughout the study.
  • Coordinated patient visits, including scheduling appointments and collecting informed consent forms.
  • Maintained accurate records of study documents, including CRFs, informed consents, and laboratory results.
  • Conducted screening interviews to determine the eligibility of possible subjects.
  • Monitored subject enrollment and tracked dropout details.
  • Supervised daily operations and maintained compliance with safety and health standards.
  • Coordinated staff schedules to ensure adequate coverage and efficient workflow.

Clinical Research Coordinator

Richmond Behavioral Associates
Staten Island, New York
02.2018 - 12.2020
  • Conducting venipuncture procedures for blood sample collection, administering and interpreting electrocardiograms (ECGs), and obtaining vital signs with precision and adherence to established protocols.
  • Engaging in collaborative efforts with Principal Investigators (PIs) and Sub-Investigators (Sub-Is) to address various facets of clinical research oversight, including adverse event (AE) and serious adverse event (SAE) reporting, assessment of inclusion and exclusion criteria, meticulous safety reporting encompassing vital signs, blood parameters, and ECG tracings, comprehensive review of medical records and history, and ensuring accountable management of subject-specific study drugs.
  • Accurately collect, record, and enter clinical trial data into databases, while maintaining and organizing source documents.
  • Coordinated clinical trials, ensuring compliance with protocols and regulations.
  • Managed participant recruitment, screening, and enrollment processes effectively.
  • Organized study documentation and maintained accurate records for audits.
  • Maintained accurate, up-to-date tracking logs for all aspects of clinical research activities, including, but not limited to, adverse events, serious adverse events, concomitant medications, and lab results.
  • Monitored patient safety during clinical trials according to established guidelines.
  • Organized investigator meetings, developed meeting agendas, created presentations, tracked action items from meetings, and coordinated follow-up communications after meetings.
  • Assessed records of each patient, reviewed databases, and checked referrals to locate potential research study participants.
  • Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.

Education

Bachelor of Arts - Psychology

Southern New Hampshire University
New Hampshire, OH
06-2026

Bachelor of Arts - Psychology

Maryville University
St Louis, MO

Certification - Medical Assistant

New Millennium Training Center
Staten Island, NY
01-2018

Skills

  • AAH registered Medical Assistant
  • Phlebotomy
  • EKG proficiency
  • Medical terminology expertise
  • Advanced and basic cardiovascular life support (ACLS/BCLS)
  • OSHA compliance
  • IATA regulations knowledge
  • Communication skills
  • Quality assurance auditing
  • Site management
  • GCP compliance
  • Regulatory compliance
  • Participant recruitment and retention
  • Multitasking and organization
  • Safety monitoring
  • SOP development

Clinical Rater Experience

  • MMSE(Mini Mental State Exam)
  • ADAS-COG(Alzheimer's Disease Assessment Scale-Cognitive Subscale)
  • CDR(Clinical Dementia Rating Scale)
  • C-SSRS(Columbia Suicide Severity Rating Scale)
  • NPI(Neuropsychiatric Inventory)
  • DSM-5(Diagnostic and Statistical Manual of Mental Disorders-5th Edition)
  • MADRS(The Montgomery-Asberg Depression Rating Scale)
  • PANSS(Positive and Negative Syndrome Scale)
  • GDS(Global Deterioration Scale)
  • BPRS(The Brief Psychiatric Rating Scale)
  • WASI(Wechsler Abbreviated Scale of Intelligence)
  • HAM-D(Hamilton Depression rating Scale)
  • PHQ(The Patient Health Questionnaire)
  • QIDS( The Quick Inventory of Depression Symptomatology)
  • CGI(Clinical Global Impression)
  • SDS(Sheehan Disability Scale)
  • BACS(Brief Assessment of Cognition in Schizophrenia)
  • MoCA(The Montreal Cognitive Assessment)

Technical Experience

  • Electronic Data Capture Systems: Medidata | Rave | Clinical Ink | Real-Time CTMS | IBM | Inform | RedCap| Medrio| Clinical Conductor|Veeva
  • IRT: Signant Health| Suvoda | Clinical Ink | Premier IRT | 4G Clinical| Calyx| PPD|Almac|Cenduit
  • IRB: WCG| Advarra/CIRBI| Sterling
  • Microsoft Office (Excel, PowerPoint, Word) Windows, Mac

Certification

  • AAH Registered Medical Assistant
  • FDA Clinical Investigator Training Course 2024

Accomplishments

  • Psi Chi, The International Honor Society in Psychology(Member)
  • Maryville University Honor Roll(2021,2022,2024 and 2025)

References

References available upon request.

Timeline

Site Manager

Tekton Research
01.2025 - 06.2025

Clinical Research Coordinator III

Holy Name Medical Center
07.2024 - 12.2024

Senior Clinical Research Coordinator/Site Supervisor

Richmond Behavioral Associates
01.2021 - 06.2024

Clinical Research Coordinator

Richmond Behavioral Associates
02.2018 - 12.2020

Bachelor of Arts - Psychology

Southern New Hampshire University

Bachelor of Arts - Psychology

Maryville University

Certification - Medical Assistant

New Millennium Training Center

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