Ese Freeman O.

917-***-**** adz226@r.postjobfree.com Albany, NY 12203

Summary

Skilled Clinical Research Associate with over 5 five years in the clinical research industry. Highly knowledgeable in company SOPs while complying with ICH GCPs. Performed site selections visits, site initiation visits, interim monitoring visits, and close-out visits in phases I, II, III, and IV.

Therapeutic Area

Indication

Phase

CNS

Schizophrenia and Bipolar

II and III

Dermatology

Acne and Rosacea

I, II and III

IVD

Chlamydia and Gonorrhea

II, III

Oncology

NSCLC

III

Medical Device

GI

III, IV

Vaccine

COVID-19

Emergency

CNS

Headache and Migraine

I, II and III

Professional Experience

NEW YORK STATE DEPARTMENT OF HEALTH

NYSDOH FELLOWSHIP FEB. 2022 - PRESENT

• Collaborated with the Bureau of Environmental and Occupational Epidemiology, Center for Environmental Health, to work on the CDC cooperative agreements for environmental health surveillance activities, including the statewide COVID-19 wastewater-based epidemiology program and other pathogens of public health interest.

ICON PLC – (Home Based)

Clinical Research Associate II JULY 2020 - FEB. 2022

Assist site in problem solving and issue resolution as required throughout the study.

Train and re-train new research personnel, including Study Coordinators, Investigators, and site pharmacists.

Perform site close-out visits to complete closeout tasks including test article reconciliation and disposition, review of accuracy and completeness of study files, retrieval of all outstanding documents and return of all study equipment.

Work closely with team members to ensure timely resolution of issues and obtain direction from CTL and management.

Proficient in multiple, different Electronic Data Capture and report writing systems.

Develop project specific tools and documents, such as protocol deviation and adverse event databases and reports.

Gather and maintain documentation for site specific files in accordance with FDA regulations and company SOP’s.

Monitor drug inventory, dispensing, compliance, and return

Track and report site enrollment, progress and adverse events

Ensure that regulatory documents are complete and compliant with federal and internal guidelines.

Assure Investigator and site adherence to timelines and GCP guidelines.

Prepare and submit trip reports, expense reports and timesheets in a timely manner.

SYNEOS HEALTH – (Home Based)

Clinical Research Associate i JAN 2019 – JULY 2020

Responsible for monitoring investigational sites to ensure that investigators and site personnel are meeting their obligations and are compliant with protocol, applicable local regulatory requirements, and ICH GCP guidelines.

Facilitate Investigator site identification process and perform site evaluation visits to ensure that investigational sites are suitable and capable of conducting the prospective study.

Facilitate site start up activities including budget negotiation, contract development and negotiations, site initiation visits and GCP instruction to Investigators/Research Personnel

Facilitate the setting up of new research sites and guided sites on submission of regulatory documents.

Provide clinical trial and protocol training during SIVs and participate in site training during Investigator meetings.

Perform ongoing monitor visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight, regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication.

Ensure SAEs are promptly reported to the IRB and that affected subjects are given adequate medical care where applicable.

Prepare and submit trip reports, expense reports and timesheets in a timely manner.

PLANNED PARENTHOOD OF SOUTHERN N. ENGLAND

CLINICAL STUDY COORDINATOR OCTOBER 2018 – JAN 2019

• Coordinated clinical trial studies and ensured compliance with approved study protocols and HIPAA guidelines.

• Assisted with the development and implementation of study-specific monitoring and reporting procedures.

• Conducted continuous monitoring activities, ensuring compliance with protocol, GCP, and applicable regulations.

INTERNATIONAL CENTER FOR ADVOCACY ON THE RIGHT TO HEALTH [ICARH]

STRATEGIC KNOWLEDGE MANAGEMENT AND LEARNING MAY 2015 – AUGUST 2018

Conducted site selection for potential sites to evaluate their capabilities for conducting a clinical trial.

Managed assigned study sites and networks, conducting phase I-III protocols according to the monitoring plan and IC procedures.

Conducts site selection for potential sites to evaluate their capabilities for conducting a clinical trial. Recommends sites to participate in clinical trial. Is the frontline liaison between ICARH and sites to ensure successful collaboration, meeting ICARH’s expectation on milestone and deliveries.

Manages assigned study sites and networks, conducting phase I-III protocols according to the monitoring plan and ICARH procedures. Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects. Performs continuous training for amendments and new site personnel as required. Retrains site personnel as appropriate.

Designed the formative research protocol, Monitoring and Evaluation Plan for the project cycle, budgeting, process evaluation study plan for the PAFiN grant.

Assisted in the design of the IHVN trust study and cancer screening and treatment for Men Who Have Sex with Men (MSM).

COMPUTER SKILLS

CMTS: Medidata CTMS, Veeva Vault, Insight, Impact

EDC: Medidata RAVE, Inform, Veeva Vault, IBM, Clinpal, E-clinical Health

Trial Master File: Veeva Vault and Trial Interactive

IRT/IVRS/IWRS: Endpoint, GxP R Brain, Clinitec, ITclinical,

EDUCATION

PhD- Public Health SUNY, University at Albany, USA. May 2024

MPH – Health Promotion & Education Southern Connecticut State University

(SCSU), USA May. 2020

MPH – Environmental Health Sciences University of Ibadan, Nigeria Aug. 2015

BSc – Biochemistry Delta State University, Nigeria Feb. 2009

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