Zilane Morancy
Orlando,FL
Summary
Dynamic Research Data Coordinator with extensive experience at AdventHealth Orlando, specializing in clinical data analysis and regulatory compliance. Demonstrating success in the enhancement of patient support and optimizing data management processes. Bilingual communicator adept at fostering collaboration among teams while ensuring strict adherence to GCP and FDA regulations, leading to successful clinical trial outcomes. Seeking to leverage expertise in a challenging role to further advance clinical research initiatives.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Research Data Coordinator 2
AdventHealth Orlando
Orlando, US
10.2023 - Current
- Manage and ensure the accuracy and timeliness of retrieval and electronic data entry submission according to protocol driven data points towards relevant research sponsors/organizations within the specified time frame
- Abstract and record essential physical and test data from internal and external sources
- Maintain a tracking system of study participants at the relevant time points as deemed necessary
- Conduct follow up visits and data searches, as assigned, to maintain smooth operational flow
- Prepare and provide participant status reports to leadership as requested
- Complete and maintain sponsor training and certifications on protocol-specific Electronic Data Capture (EDC) systems and portals (e.g., Medidata RAVE, Oracle, Inform, REDCap, etc.)
- Actively contribute to ongoing research activities including meeting with the study sponsor monitors, CRCs and Principal Investigators to review study data and resolve data queries
- Work collaboratively and proactively with Clinical Research Coordinators, study Investigators, and other research-related personnel
Research Support Assistant - Data Manager
AdventHealth Orlando
Orlando, US
02.2023 - 10.2023
- Assist the Clinical Research Coordinators in the conduct of Phase I-IV industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, FDA Regulations, and ICH/GCP Guidelines
- Meet study-specific goals and timelines and communicate effectively and appropriately with other members of the study team
- Maintain study charts to coincide with current protocol and research participant visits
- Respond to data clarification requests (queries) in a timely manner
- Ensure maintenance of proper research certifications; project timelines updates; and literary searches
- Enter and update information into the appropriate database
- Assist with study close out activities
- Supports the research team by: creating/maintaining accurate files; copying, scanning, uploading, faxing and emailing documents as necessary
- Communicate appropriately and effectively with investigators, industry collaborators, study monitors, physician offices, ancillary departments, staff and patients
- Conform to all standard operating procedure practices and abide by current IRB, FDA, federal, state and institutional regulations pertaining to human subject's research
- Understand and abide by HIPAA regulations
- Review protocol documents and perform required activities as exhibited through collaboration with the CRC
- Participate in initial and ongoing protocol training per the study requirements
- Ensure that all data from clinical research studies are collected and recorded correctly
- By protecting the integrity of the data, and by allowing accurate conclusions to be extracted from it
- Manage clinical data queries
- Review and maintain data management documentation and record management systems
- Review case report forms to ensure that the information recorded is complete, accurate, and compliant with study protocols
- Prepare reports and presentations with updates on clinical trial progress
- Organize and analyze clinical trial data to identify important trends/issues
- Identify new tools, systems, and processes to manage and process data more accurately, and coordinate with IT staff to ensure compatibility with existing systems
- Review study protocols to ensure compliance with regulatory standards
Unblinded Pharmacist
Accel Research Sites
DeLand, US
09.2021 - 02.2023
- Maintain the blind by not disclosing any information that may reveal a subject's treatment to the subject, blinded site personnel, or sponsor personnel
- Prepare, compound, and administer investigational drugs and materials issued by the Investigational Drug Service for ongoing research studies
- Manages required record-keeping, shipping, ordering, and inventory activities
- Ensure the accuracy and integrity of products prior to their delivery to trial subjects
- Ensure compliance with all applicable ARS governmental, and sponsor regulations, laws and policies related to the conduct of trials involving investigational or marketed drugs
- Maintain records to meet sponsor requirements, FDA regulations and legal requirements for pharmacy operations
- Read, interpret and processes orders for investigational drug
- Accurately dispense medications and prepare sterile products, following proper aseptic and cytotoxic technique
Research Lab Technician
Accel Research Sites
DeLand, US
09.2021 - 02.2023
- Retrieve, receive, label and analyze samples (blood, urine, etc.)
- Execute laboratory testing, make observations and interpret findings according to protocol
- Organize and store samples in accordance with all safety and other requirements to ensure the safety of personnel and integrity of the sample
- Record all data and results in specified forms (paper and electronic) with accuracy and responsibility
- Assist in ordering laboratory supplies and study specific kits
- Clean and maintain lab equipment, including recalibration of equipment
- Ensure that all safety guidelines are followed strictly at all times
Clinical Research Coordinator (CRC)
Accel Research Sites
DeLand, US
09.2021 - 02.2023
- Work directly with the patient\subject interface at the research site to deliver high-quality patient data according to local regulations, agreed scope of practice, and as required by the protocol
- Attend and participate in an investigator meeting, monitoring visits, audits, seminars, and other regions on national meetings
- Assist with pre-screening, screening, and enrollment of subjects into assigned studies
- Support subjects in trials to ensure a positive patient experience
- Assist with the establishment of a recruitment and contingency plan for each study
- Perform functions necessary for successful completion of all protocol required visits\procedures such as vital signs, phlebotomy, diagnostic tests, dispensing of the investigational product, scheduling, drug accountability\reconciliation, and organizational tasks, where appropriate and as delegated by the investigator, in accordance with local country requirements
- Accurately complete source documents and case report forms in both paper and electronic format
- Assist investigators with recording and reporting of adverse events and SAE as per local regulatory authority guidelines
- Assist in the clinical, operational efforts of the team throughout the ARS clinical research unit and integrated site networks
- Perform all training modules required by ARS SOP's in a timely and effective matter
- Source document completion and Data Entry
- Study and visit Preparedness & Monitor visit preparation
- Patient scheduling assistance and recruitment, as needed
- Accept direction and constructive criticism from supervisors and managers, in compliance with Accel policies and procedures
Assistant Clinical Research Coordinator
Orlando Clinical Research Center
Orlando, US
11.2017 - 09.2021
- Coordinate and conduct research protocols in a manner that ensures quality, consistency, timeliness, accuracy and patient safety
- Perform appropriate research protocol procedures in accordance with GCPs and internal SOPs
- Maintain frequent face-to-face, written and telephone contact with various persons involved in the study, including but not limited to the subjects, doctors, pharmaceutical sponsors
- Possess high-level working knowledge and understanding of the protocol, including requirements of patient eligibility, meeting enrollment goals, visit schedule, assessments and lab procedures, drug accountability, and maintenance of regulatory documents, as well as case report form, informed consent, source documentation, patient diary (when applicable), and study medication(s) for the assigned research study
- Schedule and oversee all subject visits on assigned protocols
- Facilitate pre-study, initiation, monitoring and close-out visits with the pharmaceutical representative
- Organize study documents that are complete, current, and filed accurately
- Review, file, and respond to all study specific documents, correspondence, and requests
- Manage drug accountability and study supplies
- Ensure the informed consent process is appropriately implemented
- Create and review study-specific source documents
- Cultivate professional relationships with physicians, patients, sponsors, CRAs, investigators, and IRBs
Clinical Internship
Florida Hospital
Orlando, US
01.2017 - 02.2017
- Obtained guidance and training from Nurses
- Attended emergency medical requests
- Rendered assistance to injured patients
- Performed preliminary assessment of injury to emergency patients
- Transported patients
- Inspected and maintained emergency medical equipment
- Followed infection control regulations and standards
Education
Associate in Arts (AA) - General Studies
Valencia College
Orlando, FL05-2025
Technical Certificate - Emergency Medical Technician
Mid Florida Technical College
Orlando, FL02.2017
Skills
- Comprehensive Patient Support
- Laboratory Experience
- Proficient in administering IP injections
- Clinical Data Analysis
- Venipuncture Proficiency
- GCP Expertise
- Human Anatomy Expertise
- Infection Control Practices
- Medical terminology
- Hands-On EMT Background
- Infection Control Training
- FDA regulations
- Bilingual
- Expertise in Microsoft 365 Suite
- Regulatory compliance
- Clinical research
- Protocol Evaluation
- Effective communication
- Team collaboration
- Creativity and innovation
Certification
- GCP, 11/01/17, Present
- IATA, 11/01/17, Present
- ACRP
- Bloodborne Pathogens, 11/01/16, Present
- BLS Certification, Emergency Medical Technician, 12/01/22, 12/01/24
- EMT-B
Personal Information
Work Permit: Authorized to work in the US for any employer
Languages
English
Native/ Bilingual
Haitian Creole
Native/ Bilingual
Timeline
Research Data Coordinator 2
AdventHealth Orlando
10.2023 - Current
Research Support Assistant - Data Manager
AdventHealth Orlando
02.2023 - 10.2023
Unblinded Pharmacist
Accel Research Sites
09.2021 - 02.2023
Research Lab Technician
Accel Research Sites
09.2021 - 02.2023
Clinical Research Coordinator (CRC)
Accel Research Sites
09.2021 - 02.2023
Assistant Clinical Research Coordinator
Orlando Clinical Research Center
11.2017 - 09.2021
Clinical Internship
Florida Hospital
01.2017 - 02.2017
Associate in Arts (AA) - General Studies
Valencia College
Technical Certificate - Emergency Medical Technician
Mid Florida Technical College
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