AMY HOUCK-DOMINY
DeBary,FL
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Science 37
12.2020 - 08.2024
- 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.
- 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.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Enhanced patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Facilitated clear communication between principal investigators, sponsors, and study participants for seamless trial execution.
- 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.
- Managed patient recruitment, informed consent process and data entry to support trial objectives.
- Increased participant retention rates through proactive follow-up efforts and regular engagement activities.
- Developed and maintained accurate and up-to-date case report forms and source documents.
- Prepared and maintained regulatory documents for clinical trial submissions.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Reduced data entry errors by implementing stringent quality control measures throughout the study lifecycle.
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Assisted in drafting comprehensive research reports summarizing findings, conclusions, and recommendations for further action.
- Improved recruitment rates by developing and implementing effective patient outreach strategies.
CLINICAL RESEARCH COORDINATOR/ISN SITE MANAGER
ACCEL RESEARCH SITES
02.2016 - 01.2019
- Interact with patients to determine study candidacy and conduct consent process accordingly
- Communicate with Primary and Sub Investigators for each study
- Assist with recruitment development and implementation to increase study enrollment and retention
- Knowledge of and ability to adhere to good clinical practices (GCP)
- Attention to details, strong ability to multi-task, ability to prioritize quickly and appropriately
- Ensure adverse events are reported appropriately, accurately and in a timely manner and that all follow-up activities are conducted as necessary
- Assist with preparing regulatory submissions and supporting documents for IRB review and Sponsor records
- Maintain Investigator Site Files at different sites
- Experience in the following therapeutic areas: Cardiovascular Diseases, Digestive System Diseases, Endocrine System Diseases, Musculoskeletal Diseases, Nutritional and Metabolic Diseases, Respiratory Tract Diseases, Skin and Connective Tissue Diseases, Virus Diseases, Bacterial Infection and Mycoses, Nervous System Diseases
- Proficiency in systems used: Clinical Conductor, Florence, Research Hive, OC-RDC, Impala, Medidata RAVE, TrailMax, Bioclinica, AGMed, Toolbox, Datalabs, ClinTrack, Venn Life Sciences, ERT, PPD, i360, Bracket, Exotouch, CT-engine, Perceptive MyTrials, Y-Prime, Suvoda, Fetch Eurofins, Infasario Datatrak, Florence e-binder, ICON Central Laboratories, Quintiles Laboratory, Covance Labs Xcellerate, Cenduit, Inform, Firecrest, Preclarus
PHLEBOTOMIST/PHLEBOTOMY SUPERVISOR
ADVENT HEALTH DELAND
01.2008 - 01.2016
- HIPAA compliant, office support, prioritize STAT orders
- Manage phlebotomy schedules for all shifts to minimize overtime costs
- Adhere to safety regulations, updated and trained staff on new procedures
- Annual performance reviews, assisted with the interviewing and hiring process, handled risk events
- Met with vendors to ensure the supplies were the most cost effective, kept inventory and ordered supplies, assisted with annual budget planning
- Performed venipunctures on various patients
- Computer skills proficiency with Word, Excel and PowerPoint
- Routinely collaborated with department managers to correct issues and improve services.
Education
BACHELOR OF SCIENCE - Health Service Administration
UNIVERSITY OF CENTRAL FLORIDA
12.2018
ASSOCIATES OF ART -
DAYTONA STATE COLLEGE
05.2015
Skills
- Good Clinical Practices
- Electronic Data Capture
- Documentation Management
- Adverse event reporting
- Research SOPs understanding
- Trial management
- Clinical Research Ethics
- Time Management
- Problem-Solving
- Teamwork and Collaboration
- Multitasking Abilities
- Organizational Skills
Certification
- CITI Training
- IATA Certification
- Institute for Healthcare Improvement Certificates
- NPCE Phlebotomy Certification
- 4DX Training - The four disciplines of business execution
- Lean Six Sigma Yellow Belt Training
- ACRP Ethics and Human Subject Protection
Activities
- Team captain for Relay for Life
- Team Captain for American Heart Association
- Volunteer at Night to Shine
Timeline
Clinical Research Coordinator
Science 37
12.2020 - 08.2024
CLINICAL RESEARCH COORDINATOR/ISN SITE MANAGER
ACCEL RESEARCH SITES
02.2016 - 01.2019
PHLEBOTOMIST/PHLEBOTOMY SUPERVISOR
ADVENT HEALTH DELAND
01.2008 - 01.2016
BACHELOR OF SCIENCE - Health Service Administration
UNIVERSITY OF CENTRAL FLORIDA
ASSOCIATES OF ART -
DAYTONA STATE COLLEGE
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