Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Timeline
Generic

Esther Titus

New York,USA

Summary

Strategic and hands-on clinical research physician with deep experience leading global Phase I-IV trials, and accelerating development pipelines across CROs and sponsor environments. Proven strengths in cross-functional leadership, vendor oversight, protocol optimization, and inspection readiness. Expertise spans feasibility strategy, patient enrollment, biomarker integration, and risk-based monitoring. Adept at aligning operational execution with regulatory standards (ICH GCP, FDA, EMA) while maintaining data integrity and audit readiness. Multilingual and collaborative, with a strong history of mentoring CRA teams, and supporting trial innovation in complex therapeutic areas.

Overview

15
15
years of professional experience

Work History

SENIOR CLINICAL RESEARCH ASSOCIATE II

IQVIA
03.2024 - 12.2024
  • Led global operations for Phase III oncology trials (HNSCC, Breast, BTC), guiding feasibility assessments, site selection, and performance analytics. Advised protocol updates and enrollment forecasts; enhanced site communication and sponsor engagement.
  • Conducted site performance analysis, delivering insights that guided protocol amendments.
  • Reduced enrollment ramp-up time by 28% through adaptive feasibility reforecasting.
  • Managed 15+ sites, achieving 100% TMF compliance and zero audit findings.
  • Provided biomarker and PK sampling training across global CRA teams.
  • Mentored new CRAs and supported onboarding, enhancing monitoring consistency across global teams.

SENIOR CLINICAL RESEARCH ASSOCIATE

SYNEOS HEALTH
10.2022 - 09.2023
  • Managed Phase III NSCLC and cardiovascular trials across multiple regions. Acted as key liaison between clinical teams, CROs, and sponsors. Spearheaded feasibility forecasting, risk mitigation, and site optimization.
  • Boosted enrollment by 35% through targeted feasibility reevaluation and CRO reallocation strategies.
  • Developed a GCP-compliant dashboard to monitor site data and detect performance trends early.
  • Mentored Site Managers and CTAs, ensuring alignment with evolving regulatory expectations.
  • Delivered feedback for SOP and monitoring plan revisions based on real-time site insights.

CLINICAL RESEARCH ASSOCIATE II

ICON PLC (FSP - AMGEN)
09.2021 - 09.2022
  • Oversaw Phase I-III trials in oncology, rare disease, and GI cancer. Delivered feasibility analysis and enrollment strategies. Collaborated on SOP development and data review.
  • Improved startup forecasting accuracy by 37% through implementation of standardized feasibility tracking tools.
  • Authored performance summaries that informed adjustments to site inclusion criteria.
  • Supported global training initiatives for site feasibility and device protocols.

CLINICAL RESEARCH ASSOCIATE I

POLYCRA (FORMERLY TPKR)
04.2019 - 09.2021
  • Monitored hematology and women's health trials. Managed full-site visit lifecycle and TMF review. Developed site-level feasibility insights and coordinated protocol compliance.
  • Reduced qualification cycle time by 22% through standardized reporting templates.
  • Created site risk dashboards to monitor protocol deviations and recruitment trends.
  • Supported three multi-site trials that passed sponsor audits with zero findings.
  • Conducted onboarding and procedural coaching for junior site staff.

CLINICAL RESEARCH COORDINATOR, ONCOLOGY

FIRST FAMILY CARE PRIVATE CLINIC
New York, NY
09.2018 - 04.2019
  • Supported site startup, informed consent, and data collection for oncology studies.
  • Enhanced patient follow-up completion by 30%.
  • Provided feasibility data that contributed to eligibility criteria updates.

CLINICAL ADMINISTRATOR

AMERIHEALTH
New York, NY
04.2017 - 09.2018
  • Maintained EHRs, supported patient documentation, and facilitated follow-ups.
  • Ensured HIPAA compliance across all documentation workflows.

RESIDENT MEDICAL OFFICER / PHYSICIAN

INDIAN PRIVATE HOSPITAL
, India
10.2009 - 07.2016
  • Directed clinical care in inpatient and emergency settings; contributed to observational research, audit documentation, and feasibility planning.
  • Presented departmental protocol recommendations that enhanced internal SOP adherence.
  • Collaborated on hospital research planning, screening protocols, and safety reporting.

Education

Doctor of Medicine (M.D.) -

Kazan State Medical University
Russia

Master's in Hospital Administration (MHA) -

Datta Meghe Institute of Medical Sciences (DMIMS)
India

Advanced Drug Safety & Pharmacovigilance -

Sollers College
NJ

Skills

  • Clinical research methodologies
  • Clinical trial design
  • Patient recruitment
  • Data analysis
  • Statistical methods
  • Clinical data management
  • Regulatory compliance
  • Biostatistics

Accomplishments

  • Delivered a Phase III oncology trial 2 months early with 100% TMF compliance across 15+ sites.
  • Boosted enrollment by 35% in neurology trial through adaptive feasibility strategy.
  • Increased feasibility forecasting accuracy by 37% via standardized tool development.
  • Recognized for zero audit findings across 3 global, multi-site studies.

Languages

  • English (Fluent)
  • Hindi (Fluent)
  • Russian (Fluent)
  • Urdu (Fluent)

Timeline

SENIOR CLINICAL RESEARCH ASSOCIATE II

IQVIA
03.2024 - 12.2024

SENIOR CLINICAL RESEARCH ASSOCIATE

SYNEOS HEALTH
10.2022 - 09.2023

CLINICAL RESEARCH ASSOCIATE II

ICON PLC (FSP - AMGEN)
09.2021 - 09.2022

CLINICAL RESEARCH ASSOCIATE I

POLYCRA (FORMERLY TPKR)
04.2019 - 09.2021

CLINICAL RESEARCH COORDINATOR, ONCOLOGY

FIRST FAMILY CARE PRIVATE CLINIC
09.2018 - 04.2019

CLINICAL ADMINISTRATOR

AMERIHEALTH
04.2017 - 09.2018

RESIDENT MEDICAL OFFICER / PHYSICIAN

INDIAN PRIVATE HOSPITAL
10.2009 - 07.2016

Doctor of Medicine (M.D.) -

Kazan State Medical University

Master's in Hospital Administration (MHA) -

Datta Meghe Institute of Medical Sciences (DMIMS)

Advanced Drug Safety & Pharmacovigilance -

Sollers College

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