Iris Moscoso
Hamburg,NJ
Summary
Dedicated Clinical Research Professional with extensive experience in successfully leading clinical trials and surpassing targets through strategic planning and effective patient recruitment. Proficient in regulatory compliance and electronic data capture (EDC) systems, I excel at fostering team collaboration while maintaining high standards of data integrity. My meticulous attention to detail and strong organizational skills have significantly reduced protocol deviations, underscoring my commitment to excellence in clinical research.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator
TKL Research, Inc.
02.2024 - Current
- Directed clinical trials, successfully meeting enrollment and study completion targets through effective planning and strategic patient recruitment initiatives.
- Initiated the development of standard operating procedures (SOPs) and manual of operations (MOPs) templates for company-wide adoption, enhancing the integrity of documentation for FDA submissions.
- Reduced protocol deviations by providing comprehensive training and support to research staff.
- Managed budgetary aspects of clinical trials, and ensured cost-effective resource allocation.
- Collaborated with investigators to develop innovative clinical trial designs, optimizing data collection methods for better results.
- Contributed to the successful completion of numerous multi-million dollar studies by coordinating all aspects of trial initiation, execution, and close-out activities.
- Implemented quality control measures across all areas of the study process to ensure accurate, reliable data collection and analysis.
- Enhanced data quality by closely monitoring study metrics and resolving discrepancies in a timely manner.
- Coordinated with other departments such as biostatistics and regulatory affairs to streamline processes and ensure successful project completion.
- Fostered a positive working environment for research staff through regular team-building activities and ongoing professional development opportunities.
- Served as a liaison between site personnel, investigators, and sponsors to ensure clear communication throughout the trial process.
- Facilitated clinical trial progression, effectively managing multiple projects simultaneously.
- Ensured compliance with regulatory requirements by conducting thorough audits of study documents and procedures.
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Prepared and maintained regulatory documents for clinical trial submissions.
Clinical Research Coordinator
TKL Research, Inc.
03.2022 - 01.2024
- Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gathered, processed, and shipped lab specimens.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
- Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
- Assessed patients'' eligibility criteria following strict adherence to inclusion/exclusion guidelines.
- Trained new team members on essential clinical research protocols and procedures, promoting a culture of continuous learning.
Assistant Clinical Research Coordinator
TKL Research, Inc.
08.2021 - 02.2022
- Assisted in preparing informed consent forms, study protocols, case report forms (CRFs) and 40+ other study-related material.
- Collected and maintained patient demographics, medical history, laboratory results, and adverse event reporting.
- Gathered, processed, and shipped lab specimens.
- Assisted in data collection and quality of data integrity.
Senior Clinical Research Laboratory Technician
TKL Research, Inc.
01.2015 - 07.2021
- Developed strong relationships with vendors, negotiating favorable terms for essential laboratory materials and services.
- Enhanced laboratory efficiency by streamlining sample processing and data collection procedures.
- Reduced waste and conserved resources through careful monitoring of inventory levels and timely ordering of supplies.
- Optimized workflows by implementing innovative solutions for common laboratory challenges, such as sample handling or reagent preparation.
- Participated in lab meetings and project presentations.
- Trained and supervised junior technicians in laboratory protocols.
- Developed new protocols and improved existing laboratory processes.
Education
Bachelor of Arts - Liberal Studies
Thomas Edison State University
Trenton, NJ05-2019
Associate of Science - General Science
Bergen Community College
Paramus, NJ12-2016
Skills
- Clinical trial management
- Strong knowledge of Regulatory Compliance, GCP, ICH Guidelines and FDA Regulations
- Proficient in Microsoft Office Suite and electronic data capture (EDC) systems
- Excellent organizational, communication, and interpersonal skills
- Ability to work independently and collaboratively in a team environment
- Detail-oriented and committed to producing high-quality work
Certification
- Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals.
- NIDA Certificate
- IATA Shipping and Transport of Dangerous Goods Certification – International Air Transport Association.
- Advanced Cardiac Life Support
- Certified Patient Care Technician/Assistant (CPCT/A) - The National HealthCareer Association (NHA)
- Certified Phlebotomy Technician (CPT) - The National HealthCareer Association (NHA)
Languages
Spanish
Native or Bilingual
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
- Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals.
- NIDA Certificate
- IATA Shipping and Transport of Dangerous Goods Certification – International Air Transport Association.
- Advanced Cardiac Life Support
- Certified Patient Care Technician/Assistant (CPCT/A) - The National HealthCareer Association (NHA)
- Certified Phlebotomy Technician (CPT) - The National HealthCareer Association (NHA)
Bachelor of Arts - Liberal Studies
Thomas Edison State University
Associate of Science - General Science
Bergen Community College
Similar Profiles
Maria AquinoMaria Aquino
Recruiter at TKL Research, Inc.Recruiter at TKL Research, Inc.
Judith KatsnelsonJudith Katsnelson
Clinical Research Assistant at TKL ResearchClinical Research Assistant at TKL Research
Anita PalokajAnita Palokaj
Quality Control Associate I at TKL ResearchQuality Control Associate I at TKL Research