Leo Then
Clinical Trials
Miami,FL
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Organized and thorough with good planning and problem-solving abilities, experience working in CRO and Sponsors. Enthusiastic Researcher eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Motivated to learn, grow and excel in Clinical Trials.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Country Coordinator
Marken, LLP
Remote
10.2021 - Current
- Dealing directly with home health care organizations, home health care agencies (HCA) and home health care providers (HHCP), study sites as well as internal stakeholders involved in conduct of trial within Global Patient Centric Services; including Direct to Patient logistics, Kit Production, and Depot team members
- Provides necessary country level support to Home Health Care team
- Identify, qualify, onboard, and train home care agencies and providers and home care visit execution activities
- Managing/updating vendors and nurse network database, coordinating with country specific logistics
- Responsible for agency and provider identification and qualification
- Raining of Home Health Care Providers (HHCP) on Marken training curriculum, home care scope of services, and home health care technology: Marken Apollo (EDC/CTMS)
- Collection of required home care provider documents (i.e., cv, licensure, medical license, etc)
- Assist with document collection at site level – including PI approvals of HHCPs (Delegation of Authority log)
- Support coordination of visit logistics with HHCP and Patient and track to completion
- Submission of home health care visit documentation to the study site within 24 hours of visit
- Created HHCP profiles in Marken’s proprietary software system Marken Apollo and update as needed
- Assigned HHCP to study specifics in Apollo
- Attend Sponsor Meetings
- Serve as liaison between HHCP and Principal Investigator's
- Created Source documents
- Source Document Approval and Verification after each visit., as well as QA of sources
- Scheduled subject visits
- Regulatory filing and submitting documents to IRB
- Prepare for upcoming Interim Monitoring Visits and Site Initiation Visit
- Followed Up on AE/SAE
- Maintained study related and logs and timesheets
- Create Checklists and logs and maintain as well
- QA of documents and licensure's of Provider’s and Study Team
- Referred clients to appropriate team members, community agencies and organizations to meet Study needs.
Clinical Research Coordinator
Medix
Hallandale Beach, FL
01.2020 - 12.2020
- Patient Recruitment
- Administered Medications at Specific Time Point
- Documentation of Patients and Medications and Trials
- Electronic Data Capture entry from Source Documents
- Created Source documents
- Scheduled subject visits
- Performed study related activities at study specific time-points per protocol
- Regulatory filing and submitting documents to IRB
- Prepare for upcoming Interim Monitoring Visits and Site Initiation Visits
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals and case report form requirements.
Clinical Trial Assistant
Biorasi, LLC
Aventura, FL
06.2019 - 02.2020
- Clinical Operations in tracking of subject recruitment at all study sites, the tracking of study monitoring Visits, and of protocol deviations, reporting and trending
- Assist in communication to sites
- Serves as Clinical Trial Assistant (CTA) on Projects
- Study Start-up:, , Clinical Operations in site initiation, to include preparing and/or reviewing study-related documents (e.g., Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Pharmacy Manual, and CRF Completion Guidelines, study logs and forms)
- Site Activation: Coordinates with the clinical project team in retrieval and review of regulatory documents required for initiation of a clinical trial
- Document and Supplies Management: assist Project Team in the collection, review and filing of site Essential Documents, and maintenance of the TMF
- Assist in the tracking of clinical supplies at site in coordination with established systems such as IWRS, EDC and CTMS
- Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies
- Assist the Project team in the resolution of audit findings; assist Project team in review and maintenance of clinical trial documentation for audit readiness.
- Partake in regular team meetings / teleconferences
- Participate at Client Presentation Meetings and Investigator Meetings as necessary
- Communicate any out-of-scope issues to upper management as soon as identified
- Assisting the study teams in meeting timelines
- Other duties as assigned.
Clinical Research Coordinator/Regulatory Specialist
BioImage2/Chenmed
Fort Lauderdale, FL
01.2017 - 05.2019
- Performed diverse responsibilities requiring analysis, judgment, and knowledge of specific study protocols
- Complete all case report forms and source documentation
- Maintained accurate, confidential files and documentation of study participants
- Retained study participants per protocol, schedule all procedures and assessments for subjects, draw blood/prepare samples for labs
- Maintained day-to-day operations of the Regulatory Binders
- Assisted with vendor verification and qualification
- Faciliatated with study launch and study start-up activation process
- Coordinator and assisted with implementing internal quality improvement projects
- Racked workflow of new awarded research studies and ensure project deadlines
- Assist with the hiring and training process
- Reported, monitored, distributed, and maintained files for all safety information including Investigational Drug Brochures, IND safety reports and Serious Adverse Events (SAE) reports
- Updates Clinical Trials Management System (CTMS) as needed with location profile information (CVs, medical licenses, laboratory accreditations), IRB status, consent form versions (protocol/consent form evolution ion), and safety information
- Prepared regulatory documentation packets and creates all FDA 1572 Forms for initial submissions
- Ensures all necessary forms are submitted to Sponsor company to activate protocols
- Distributes and tracks financial disclosure forms, protocol signature pages and FDA 1572 Forms to obtain Principal Investigator signatures
- Racked expirations and retrieves current documentation for medical licenses, CVs and laboratory accreditations
- Posts regulatory documents including protocols, amendments, consent forms, SAE forms etc
- To the site
- Prepared, maintains, updates and audits study specific regulatory files, IRB files and location profile filing system per FDA guidelines and resolves queries as necessary
- Maintained master location lists to be used for regulatory purposes
- Provided FDA regulatory updates to managers
- Distributed IRB documentation and post IRB meeting information to research staff
- Ensures all regulatory files are prepared for off-site storage in accordance with FDA and other applicable regulatory guidelines.
Clinical Research Coordinator / Regulatory Assistant
WCG Threewire / Syneos Health, Univ. of Miami Hosp, Sylvester Cancer Center
Miami, FL
01.2017 - 08.2017
- Performed study events and collected data as required per protocol
- Notified appropriate staff of abnormal results while collecting data, adverse events, or unusual incidents
- Patient recruitment, conducting patient visits with the investigators and before and after surgery after surgery
- Etting up interim monitoring visits
- Sat in on Investigator’s clinics to help identify potential candidates for the study
- Performed completion of case report forms
- Reported serious adverse events per protocol
- Prepared, submitted, and maintained regulatory documents
- Recruited and consented
- Scheduled all procedures and assessments for subjects
- Drew bloodwork
- Prepared samples for labs
- Electronic Data Capture entry
- Patient recruitment, conducting patients with the investigators clinics to help identify potential candidates for the studies
- Patient recruitment
- Conducted subject visits with the Investigators before and after surgery.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Financial Analyst / Clinical Research Coordinator
Miami Dade Medical Research Institute, LLC
Miami, FL
01.2016 - 12.2016
- Worked side by side with Chief Financial Officer and retired FBI agent on protocol budgets
- Pass Throughs
- Handled sites finances and payroll
- Placed advertisements in local newspapers and magazines, as well as new s stations.
- Conducted patient visits with investigators
- Electronic Data Capture entry
- Performed study events
- Collected data as required per protocol
- Drew bloodwork
- Prepared samples for labs.
Assistant Project Manager
International Dermatology Research, Inc
Miami, FL
06.2015 - 03.2016
- Oversaw the site studies
- Oversaw the Study Coordinators
- Ensured all queries were answered
- Ensured all data entered in the Electronic Data Capture
- Oversaw Regulatory and quality assurance
- Set up SIV’s, IMV’s and close out visits
- Worked with television and newspapers companies for advertising and recruitment
- Conducted patient visits with the investigators
- Drew lab specimens
- Processed lab specimens.
- Implement new policies and educate staff on changes.
- Supported senior managers and department leaders by completing projects and problem resolution under tight budgets and schedule demands.
- Closely collaborated with project members to identify and quickly address problems.
Clinical Research Coordinator
IMA Research
Miami, FL
11.2013 - 05.2015
- Patient Recruitment
- Administered Medications at a Specific Time Point
- Documentation of Patients and Medications and Trials
- Scheduled appointments
- Electronic Data Capture entry
- Handled physicals for DOT, Workers Compensation, and drug testing
- Conducted study visits alongside the Investigators
- Drew and processed laboratory specimens
- Regulatory filing and submitting documents to IRB.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Collected data and followed research protocols, operations manuals and case report form requirements.
- Screened patient records, databases and physician referrals to identify prospective candidates for research studies.
- Gathered, processed and shipped lab specimens.
- Followed informed consent processes and maintained records.
- Quickly learned new skills and applied them to daily tasks, improving efficiency and productivity.
Research Coordinator
Gildian’s Choice
Miami, FL
01.2010 - 01.2014
- On call for Site Initiation visits, Interim Monitoring visits and Regulatory
- Conducted patient visits with the investigators
- Quality assurance
- Chose advertisements for recruitment
- Electronic Data Capture Entry.
- Coordinated protocol development, equipment preparation and materials purchasing for planned studies.
- Prepared documents, reports and presentations detailing results and conclusions.
Medical Assistant
Fast Care Urgent Care
Miami, FL
01.2012 - 01.2013
- Measured vital signs, such as pulse rate, temperatures blood pressure, weight/height
- Performed Stress Test
- Performed EKG’s
- Assisted Medical Doctors with patient visits
- Worked with electronic medical records
- Prepared treatment rooms for examination of patients
- Inventoried and ordered medical supplies and materials
- Received callers at the establishment, determined the nature of business and direct callers to the destination.
- Sanitized, restocked and organized exam rooms and medical equipment.
- Obtained client medical history, medication information, symptoms and allergies.
- Directed patients to exam rooms, fielded questions and prepared for physician examinations.
- Collected and documented patient medical information such as blood pressure and weight.
- Performed clerical duties, such as word processing, data entry, answering phones and filing.
- Called and faxed pharmacies to submit prescriptions and refills.
- Documented vital signs and health history for patients in clinic and hospital environments.
Medical Assistant
Mt. Sinai Medical Center
Miami Beach, FL
09.2010 - 09.2011
- Measured vital signs, such as pulse rate, temperatures blood pressure, weight/height
- Performed Stress Test
- Performed EKG’s
- Assisted Medical Doctors with patient visits
- Worked with electronic medical records
- Prepared treatment rooms for examination of patients
- Inventoried and ordered medical supplies and materials
- Received callers at establishment, determined the nature of business and direct callers to the destination.
- Sanitized, restocked and organized exam rooms and medical equipment.
- Obtained client medical history, medication information, symptoms and allergies.
- Directed patients to exam rooms, fielded questions and prepared for physician examinations.
- Collected and documented patient medical information such as blood pressure and weight.
- Performed clerical duties, such as word processing, data entry, answering phones and filing.
- Documented vital signs and health history for patients in clinic and hospital environments.
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
Research Assistant
South Florida Medical Research
Miami, FL
01.2008 - 01.2010
- Measured vital signs, such as pulse rate, temperatures blood pressure, weight/height
- Drew lab work and processed the labs
- Performed EKG’s
- Prepared treatment rooms for examination for participants
- Inventoried and ordered medical supplies and materials
- Participant Recruitment
- Administered Medications at a Specific Time Point
- DC Documentation of Patients and Medications and Trials
- Scheduled appointments
- Processed medical-legal documents and correspondence.
- Helped team meet regulatory requirements by coordinating documentation and filings.
Education
B.A - Health Administration
DeVry University
Online08.2023
No Degree - General Studies
Miami Dade College
Miami, FLCertification - Medical Assisting
American Registry of Medical Assistants
07.2008
No Degree - Navy Medicine/Emergency Room Technician
Hospital Corpsman School United States Navy
Great Lakes, IL05.2004
High School Diploma -
Jane Addams Business Careers High School
Cleveland, OH06.2000
Skills
Trial management
- Research SOPs understanding
- Good Clinical Practices
- Specimen collections
- Informed consent
- Medication dispensing
- Schedule Coordination
- Organization and Time Management
- Excellent Communication
- Good Telephone Etiquette
- Active Listening
- Interpersonal Communication
Certification
National Institutes of Health Web-Based Training (NIH)
Collaborative Institutional Training Initiative (CITI)
IATA Dangerous Goods
Good Clinical Practice (GCP) Certification
Basic Life Support/CPR AHA
2 of 6
Additional Information
Hard worker and highly motivated, and always looking for opportunities to grow.
Languages
English
Native or Bilingual
Spanish
Native or Bilingual
Timeline
Country Coordinator
Marken, LLP
10.2021 - Current
Clinical Research Coordinator
Medix
01.2020 - 12.2020
Clinical Trial Assistant
Biorasi, LLC
06.2019 - 02.2020
Clinical Research Coordinator/Regulatory Specialist
BioImage2/Chenmed
01.2017 - 05.2019
Clinical Research Coordinator / Regulatory Assistant
WCG Threewire / Syneos Health, Univ. of Miami Hosp, Sylvester Cancer Center
01.2017 - 08.2017
Financial Analyst / Clinical Research Coordinator
Miami Dade Medical Research Institute, LLC
01.2016 - 12.2016
Assistant Project Manager
International Dermatology Research, Inc
06.2015 - 03.2016
Clinical Research Coordinator
IMA Research
11.2013 - 05.2015
Medical Assistant
Fast Care Urgent Care
01.2012 - 01.2013
Medical Assistant
Mt. Sinai Medical Center
09.2010 - 09.2011
Research Coordinator
Gildian’s Choice
01.2010 - 01.2014
Research Assistant
South Florida Medical Research
01.2008 - 01.2010
B.A - Health Administration
DeVry University
No Degree - General Studies
Miami Dade College
Certification - Medical Assisting
American Registry of Medical Assistants
No Degree - Navy Medicine/Emergency Room Technician
Hospital Corpsman School United States Navy
High School Diploma -
Jane Addams Business Careers High School
Similar Profiles
Levi BeamonLevi Beamon
Senior Warehouse Clerk at Marken LLP.Senior Warehouse Clerk at Marken LLP.
ERIN NELSONERIN NELSON
Global Sales Operations Manager at MARKEN LLPGlobal Sales Operations Manager at MARKEN LLP
Crystal TurnerCrystal Turner
Logistics Coordinator at MNX/MarkenLogistics Coordinator at MNX/Marken
Alex AyalaAlex Ayala
CUSTOMER SERVICE REPRESENTATIVE at MARKENCUSTOMER SERVICE REPRESENTATIVE at MARKEN
Mariedys Lopez ArencibiaMariedys Lopez Arencibia
Notary Public at Zory Immigration SolutionsNotary Public at Zory Immigration Solutions