Ofelia Hernandez
Mundelein
Summary
Detail-oriented Clinical Research Coordinator with almost five years of experience in managing clinical trials from initiation through completion. Proven track record in project management, successfully coordinating multi-site studies and ensuring adherence to regulatory compliance and Good Clinical Practice (GCP) guidelines. Skilled in-patient interaction, adept at recruiting and retaining participants while providing exceptional support and education throughout the trial process. Strong communicator with a collaborative approach, capable of working effectively with multidisciplinary teams to achieve research objectives.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Clinical Research Coordinator
Orchard Healthcare Research
12.2019 - Current
- Follow clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
- Screen patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Gather, process, and ship lab specimens.
- Enhance patient safety by meticulously monitoring and documenting adverse events during clinical trials.
- Collaborate with investigators, sponsors, and stakeholders to facilitate study activities and maintain effective communication.
- Recruit and screen study participants, obtaining informed consent and ensuring adherence to inclusion/exclusion criteria.
- Conduct screening and informed consent processes, providing participants with comprehensive information about the study and addressing their concerns.
- Monitor participant retention throughout the trial, employing engagement strategies to minimize dropouts and ensure a positive participant experience.
- Collect, manage, and analyz clinical data, maintaining accuracy and confidentiality in compliance with Good Clinical Practice (GCP) guidelines.
- Monitor trial progress through site visits and performed quality assurance checks to ensure protocol adherence.
- Oversee data collection processes, ensuring accuracy and integrity of data through rigorous quality control measures.
- Utilize electronic data capture (EDC) systems to manage and analyze trial data, resulting in streamlined reporting and reduced discrepancies.
- Train and supervise research staff, fostering a collaborative and compliant study environment.
- Engage with participants regarding study objectives and administered questionnaires, ensuring comprehensive data collection.
- Manage study supplies and equipment, ensuring optimal conditions for research activities.
General Manager
Five Guys Burgers and Fries
02.2011 - 12.2019
- Oversaw daily operations and maintained compliance with Five Guys standards across multiple locations.
- Led a staff of 25+, responsible for hiring, training, scheduling, and performance management.
- Managed inventory, food preparation, and store cleanliness to ensure operational efficiency.
- Prepared daily and monthly reports on gross profit, labor, P&L, and sales metrics.
- Provided exceptional customer service, resolving complaints and fostering a positive dining experience.
- Collaborated with team members to maintain a focused environment for secret shopper evaluations.
Education
Nursing
Waubonsee Community College
Sugar Grove, ILSkills
- Good Clinical Practices
- Electronic Data Capture
- Documentation Management
- Informed consent
- Leadership
- Data Analysis
- Organization
- Accuracy
- Detailed Orientation
- Excellent Communication Skills
- Research experience
- Data collection techniques
Certification
- CITI Good Clinical Practice (GCP), Expires 09 NOV 2025
- IATA Certification, Expires 05 DEC 2025
- CITI HSR Certificate, Expires 25 JAN 2025
Timeline
Clinical Research Coordinator
Orchard Healthcare Research
12.2019 - Current
General Manager
Five Guys Burgers and Fries
02.2011 - 12.2019
Nursing
Waubonsee Community College
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