Leo Then

Miami, FL *****

ad390b@r.postjobfree.com

+1-305-***-****

Clinical Research Professional with over 10 years of experience in Clinical Trials from Phases I-IV and Regulatory Affairs and Clinical Trials Assistant.

Experience with different therapeutic indications, as well as observational and device studies. CTMS and eTMF experience as well as with DIA Reference Model.

Electronic Data Capture, IWRS/IXRS Systems, CTMS and eTMF maintenance. Bilingual in English and Spanish, Computer Savvy (Microsoft Office, Google)

Medical skills such as Phlebotomy, EKG, Vital Signs, and Physicals.

Work Experience

Regulatory Affairs Specialist HCW Biologics Inc. - Miramar, FL Present

Study Startup

Collection, distribution and tracking of Essential Documents Building eTMF Structure using DIA TMF Reference Models CTMS Management

Site Management IRB Submissions

Maintaining Document and CTMS/eTMF Trackers per site

Provide support to Clinical Operations by reviewing each site prior to a monitoring visit and review and check for discrepancies and quality prior to visits

Clinicaltrials.gov management

Clinical Research Coordinator Clintex Research Group – Miami August 2020 to June 2023

Patient Recruitment

Administered Medications at a 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 timepoints per protocol Regulatory filing and submitting documents to IRB

Prepare for upcoming Interim Monitoring Visits and Site Initiation Visits

Country Coordinator

Marken a UPS Company - Remote

October 2021 to October 2022

Dealing directly with home health care organizations, home health care agencies (HCA) and home health care providers (HCP), study sites as well as internal stakeholders involved in the conduct of a trial within Global Patient Centric Services; including Direct to Patient logistics, Kit Production, and Depot team members.

Provides the necessary country level support to the 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

Training 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 the site level – including the 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

Create 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 a liaison between them and the Principal Investigators Documentation of Patients and Medications and Trials.

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 Prepare and collection of essential regulatory documents

Follow Up on AE/SAE

Maintain study related and logs and timesheets. Create Checklists and logs and maintain as well.

QA of documents and licensures of Provider’s and Study Team

Clinical Research Coordinator (Contract)

Medix - Hallandale Beach, FL

September 2020 to September 2021

Patient Recruitment

Administered Medications at a Specific Time Point

Drew and processed lab specimens per study protocol and lab manual 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 timepoints per protocol Regulatory filing and submitting documents to IRB

Prepare for upcoming Interim Monitoring Visits and Site Initiation Visits

Clinical Trial Assistant

Biorasi, LLC - Aventura, FL

January 2019 to February 2020

Site Management

Supported Manager, 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.

Study Start-up: Supported Manager, 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.

Participated in Client Presentation Meetings and Investigator Meetings as necessary. Communicated any out of scope issues to upper management as soon as identified.

Clinical Research Coordinator / Regulatory Specialist (Contract)

BioImage2/ChenMed - Lauderhill, FL

2017 to 2019

Performed diverse responsibilities requiring analysis, judgment and knowledge of specific study protocols. Complete all case report forms and source documentation.

Maintained day-to-day operations of the Regulatory Binders. Facilitated with study launch and study start-up activation process.

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.

Tracked expirations and retrieves current documentation for medical licenses, CVS and laboratory accreditations.

Clinical Research Coordinator / Regulatory Assistant (Contract) University of Miami/Dept. of Neurological Surgery/Cancer Ctr. Miami, FL

Syneos Health/Threewire - Miami, FL January 2017 to August 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.

Setting up interim monitoring visits.

Sat in on Investigators clinics to help identify potential candidates for the study. Performed completion of case report forms

Report serious adverse events per protocol.

Prepared, submitted and maintained regulatory documents. Scheduled all procedures and assessments for subjects.

Drew and processed labs.

Conducted subject visits with the Investigators before and after surgery.

Financial Analyst/Clinical Research Coordinator (Contract)

Miami Dade Medical Research Institute, LLC - Miami, FL March 2016 to December 2016

Worked side by side with Chief Financial Officer and retired FBI agent on protocol budgets

Handled sites finances and payroll.

Advertised in local newspapers and magazines. Conducted patient visits with investigators.

Project Manager Assistant / Clinical Research Coordinator

International dermatology Research, Inc - Miami, FL May 2014 to March 2016

Oversaw the site studies from startup to closeout Oversaw the Study Coordinators.

Ensured all queries were answered. Oversaw Regulatory and quality assurance. Set up SIV's, IMV's and close out visits.

EDC entry

Source Document Creation Draw Blood and Process Labs

Lead Clinical Research Coordinator

IMA Research - Miami, FL January 2013 to May 2014

Patient Recruitment

Administered Medications at a Specific Time Point. Documentation of Patients and Medications and Trials. Electronic Data Capture entry.

Regulatory filing and submitting documents to IRB.

Clinical Research Coordinator (Per Diem)

Gildian Choice Clinical Research Group, LLC - Miami, FL January 2010 to March 2013

On call for Site Initiation visits, Interim Monitoring visits and Regulatory. Conducted patient visits with the investigators.

Quality assurance.

Choose advertisements for recruitment. Electronic Data Capture Entry.

Research Assistant

South Florida Medical Research - Miami, FL August 2008 to January 2010

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

Measured vital signs, such as pulse rate, temperatures blood pressure, weight/height. and BMI

Education

B.A in Healthcare Administration (in progress)

Miami Dade College / DeVry University - Miami, FL January 2017 to Present

Technician in Health Science

Field Medical Service School - Jacksonville, NC 2005 to 2005

Technician in Health Science

U.S Naval Hospital Corps School - Great Lakes, IL 2004 to 2005

High School Diploma in General Studies

Jane Addams Business Careers Center High School - Cleveland, OH 1996 to 2000

Languages

•Spanish - Fluent

Military Service

Branch: Navy

Service Country: United States Rank: Seaman

July 2004 to July 2008

Served 4 years in the US Navy.

Certifications and Licenses

CPR Certification

Additional Information

•Computer Skills (Microsoft Office, Google)

•Electronic Data Capture

•IWRS, IXRS, IRT Systems

•CTMS

•eTMF (VEEVA Vault, Salesforce, CloudByz)

•IRB (WCG WIRB)

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