Iris M. Moscoso
Hamburg,NJ
Summary
Accomplished Senior Clinical Research Coordinator with a proven track record in successfully executing Phase-I and Phase-II trials. Possesses expertise in regulatory compliance and protocol development, complemented by strong organizational skills, and a steadfast commitment to data integrity. Demonstrated success in mentoring teams and optimizing patient recruitment strategies, resulting in high-quality clinical research outcomes. Bringing several years of experience in the field, with a strong readiness to take on a challenging, dynamic role.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator
TKL Research, Inc.
Fair Lawn, NJ
02.2024 - Current
- Directed multiple Phase-I clinical trials, meeting enrollment and study completion targets through effective planning and patient recruitment
- Coordinated and submitted research protocols to the Institutional Review Board (IRB) for review and approval, ensuring compliance with ethical and regulatory standards.
- Prepared and reviewed informed consent documents, ensuring clarity and alignment with regulatory requirements for research participants.
- Developed standard operating procedures (SOPs) and manual of operations (MOPs) templates for company-wide adoption, ensuring documentation integrity for FDA submissions
- Managed budgets and resource allocation, optimizing cost-efficiency in clinical trials
- Collaborated with investigators to develop innovative trial designs, enhancing data collection and analysis
- Coordinated multi-million-dollar studies, ensuring successful initiation, execution, and close-out activities
- Implemented quality control measures to ensure accurate, reliable data collection across studies
- Enhanced data quality through proactive monitoring and timely resolution of discrepancies
- Fostered a collaborative working environment through team-building activities and professional development opportunities
- Served as a liaison between site personnel, investigators, and sponsors, ensuring clear communication throughout the trial process
- Ensured regulatory compliance by conducting audits of study documents and procedures
Clinical Research Coordinator
TKL Research, Inc.
Fair Lawn, NJ
03.2022 - 01.2024
- Conducted study visits and followed protocols in compliance with ICH/GCP and FDA regulations
- Screened patient records and physician referrals to identify potential candidates for clinical trials
- Monitored adverse events and ensured patient safety through diligent documentation
- Collaborated with clinical staff to support accurate clinical trial data collection
- Assisted in patient eligibility assessments and ensured strict adherence to inclusion/exclusion criteria
- Trained new team members on clinical research protocols and procedures
Assistant Clinical Research Coordinator
TKL Research, Inc.
Fair Lawn, NJ
08.2021 - 02.2022
- Assisted in preparing informed consent forms, study protocols, and case report forms (CRFs)
- Collected and maintained patient demographics, medical history, lab results, and adverse event reports
- Supported data collection efforts and ensured high standards of data integrity
- Processed and shipped lab specimens, ensuring compliance with protocol
Senior Clinical Research Laboratory Technician
TKL Research, Inc.
Fair Lawn, NJ
01.2015 - 07.2021
- Built strong relationships with vendors and negotiated favorable terms for laboratory supplies and services
- Streamlined sample processing and data collection, enhancing laboratory efficiency
- Monitored inventory levels to reduce waste and ensure timely ordering of supplies
- Implemented innovative solutions to common laboratory challenges, improving workflow and reducing downtime
- Trained and supervised junior technicians in laboratory protocols
- Developed and improved laboratory processes, contributing to better overall efficiency
Education
Bachelor of Arts -
Thomas Edison State University
Trenton, NJ01.2019
Associate of Science - Health Sciences
Bergen Community College
Paramus, NJ01.2016
Skills
- Regulatory Compliance
- GCP Training
- IRB submissions
- ICH Compliance Knowledge
- Navigating FDA Compliance
- Protocol development
- Informed consent
- Adverse event monitoring
- Training and mentoring
- Proficient in Microsoft Office Suite
- Experience with Electronic Data Capture
- Strong Organizational Skills
- Verbal and Written Communication
- Ability to work independently
- Detail-oriented
Websites
Certification
- Certified Clinical Research Professional (CCRP), Society of Clinical Research Associates (SOCRA) - 2025
- NIDA Clinical Trials Network - GCP Certificate - 2024
- Advanced Cardiac Life Support (ACLS) - 2025
Languages
- English, Fluent
- Spanish, Fluent
Timeline
Senior Clinical Research Coordinator
TKL Research, Inc.
02.2024 - Current
Clinical Research Coordinator
TKL Research, Inc.
03.2022 - 01.2024
Assistant Clinical Research Coordinator
TKL Research, Inc.
08.2021 - 02.2022
Senior Clinical Research Laboratory Technician
TKL Research, Inc.
01.2015 - 07.2021
Bachelor of Arts -
Thomas Edison State University
Associate of Science - Health Sciences
Bergen Community College
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