Work Preference
Summary
Overview
Work History
Education
Skills
Certification
Personal Information
Timeline
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Open To Work

HELINA TADESSE

Alexandria,Virginia

Work Preference

Job Search Status

Open to work
Desired start date: 2 weeks notice

Desired Job Title

Lead Clinical Research AssociateClinical Research AssistantClinical Trial ManagerClinical Operations AssociateClinical Research Specialist

Work Type

Full TimeContract Work

Location Preference

RemoteHybrid
Location: Alexandria, Virginia
Open to relocation: No

Salary Range

$110000/yr - $140000/yr

Important To Me

Work from home optionCareer advancementPersonal development programsHealthcare benefitsCompany CultureWork-life balance

Summary

ACRP-certified Senior Clinical Research Associate with 10+ years of experience in clinical research and biotech, leading the execution and oversight of Phase I-III clinical trials and registry studies across cardiovascular, infectious disease, neurological, and autoimmune therapeutic areas, with particular focus in rare disease studies. Proven strength in study operations, site and vendor oversight, TMF management, risk mitigation, and cross-functional collaboration to ensure regulatory compliance, data integrity, and audit readiness. Recognized for driving operational quality, mentoring teams, and contributing to successful trial delivery through proactive problem-solving and continuous process improvement.

Overview

16
16
years of professional experience
1
1
Certification

Work History

Lead Clinical Research Associate

Leadiant Biosciences
Alexandria, United States
01.2020 - Current
  • Conduct site qualification, initiation, monitoring, and close-out visits for Phase II-III clinical trials ensuring adherence to protocol, ICH-GCP, FDA regulations, and SOPs.
  • Perform source data verification (SDV) to ensure data accuracy and integrity.
  • Monitor patient safety reporting, adverse events (AEs), and serious adverse events (SAEs).
  • Provide operational oversight and guidance for the execution of four Phase II-IV clinical trials, supporting study timelines, regulatory compliance, and audit readiness.
  • Contribute to vendor selection activities for assigned clinical trials.
  • Support the management of assigned clinical trials and oversee CRO activities including study timelines, deliverable quality, and trial budgets throughout the study lifecycle.
  • Serve as a key operational partner to Clinical Trial Management and cross-functional teams to support study planning, execution, and delivery of program milestones.
  • Lead and contribute to the development, review, and implementation of clinical trial operational documents, including study protocols, Investigator Brochures, monitoring plans, safety management plans, data management plans, statistical analysis plans, ICFs, CRFs, and Clinical Study Reports.
  • Track and report key study performance and quality metrics, including enrollment progress, data quality indicators, safety events, and investigational product supply.
  • Oversee and maintain documentation within Trial Master Files (TMFs) and review EDC systems for assigned studies and sites, ensuring contemporaneous filing, quality review, and regulatory document reconciliation.
  • Support inspection and audit readiness activities, including internal audits and health authority inspections, through proactive documentation oversight and issue resolution.
  • Identify operational, compliance, and quality risks and implement mitigation strategies in collaboration with study teams and leadership.
  • Support development, maintenance, and periodic revision of Clinical Operations Standard Operating Procedures (SOPs) and Quality Management System (QMS) processes.
  • Lead annual GCP training planning and coordination for the Clinical Operations department to maintain regulatory and company SOP compliance.
  • Coordinate with Finance to manage study-related financial activities, including site and vendor budgets, invoice reconciliation, accrual tracking, and monthly variance reporting.
  • Prepare and coordinate regulatory submissions with the regulatory affairs team.
  • Coordinate with the Legal department for the implementation of work orders, vendor contracts, and other project-related functions requiring cross-department assistance.
  • Collaborate cross-functionally with Clinical Operations, Data Management, Safety, Regulatory Affairs, and Biostatistics to ensure program deliverables and organizational goals are achieved across multiple studies and sites.
  • Conducted collaborations under a Cooperative Research and Development Agreement (CRADA) between industry and federal partners.

Clinical Research Associate

Tasly Pharmaceuticals/Axeon Research Corp
06.2013 - 01.2020
  • Monitored Phase I-III clinical trials across multiple therapeutic areas, including infectious disease, rare disease, and cardiovascular indications.
  • Conducted investigator and site feasibility assessments to support IND submissions and study start-up activities.
  • Supported Clinical Trial Managers and Project Managers with site identification, selection, activation, and enrollment readiness planning.
  • Prepared, reviewed, and maintained Investigator Site Files (ISF) and regulatory documentation to ensure audit and inspection readiness.
  • Conducted pre-study, site initiation, and routine monitoring visits (PSVs, SIVs, and IMVs) to ensure protocol compliance, participant safety, and data integrity through source data verification (SDV), query management, and collaboration with data management teams.
  • Identified compliance issues and authored corrective and preventive action (CAPA) plans as required.
  • Verified investigational product accountability, storage, and handling in accordance with protocol and regulatory requirements.
  • Ensured timely and accurate reporting of adverse events (AEs) and serious adverse events (SAEs) to IRBs/IECs and sponsors.
  • Provided onboarding and ICH-GCP training to newly hired CRAs and supported ongoing monitoring excellence.

Research Associate

CD Diagnostics
02.2012 - 05.2013
  • Ensured regulatory and protocol compliance by overseeing informed consent processes prior to biological sample collection.
  • Coordinated and managed biological sample collection across multiple investigators and study sites, including development and maintenance of sample collection and requisition documentation.
  • Oversaw documentation, inventory tracking, and ultra-low temperature storage (−80C) of biological samples within study databases to ensure data integrity and traceability.
  • Managed vendor interactions for procurement of laboratory equipment and supplies and performed ELISA assays supporting assay development and validation activities.

Research Coordinator

Fox Chase Cancer Center
06.2011 - 01.2012
  • Supported the Lead Research Coordinator with protocol development, IRB submissions, and regulatory documentation.
  • Consented and enrolled study participants and collected clinical samples in compliance with HIPAA and institutional policies.
  • Assisted with logistical planning and execution of the African-Caribbean Cancer Consortium Philadelphia conference.
  • Participated in community outreach initiatives and health fairs, providing health education and basic screening opportunities.

Scientific Technician

Fox Chase Cancer Center
06.2010 - 05.2011
  • Collected blood samples following established safety procedures and laboratory protocols.
  • Processed blood and urine specimens for submission to research laboratories, ensuring proper labeling and chain of custody.
  • Isolated lymphocytes from whole blood samples and performed DNA extraction, purification, and concentration analysis.
  • Performed quality control (QC) checks on biological samples and prepared materials for shipment.
  • Managed laboratory inventory, ensuring availability of supplies and compliance with storage requirements.

Education

B.S. - Biochemistry & Cellular and Molecular Neuroscience

Temple University

Skills

  • Clinical Research
  • ICH-GCP
  • FDA Regulations
  • Standard Operating Procedures (SOPs)
  • Site Oversight
  • Site Qualification (PSV)
  • Site Initiation Visits (SIVs)
  • Routine Monitoring Visits (IMV)
  • Close Out Visits (COV)
  • Source Data Verification (SDV)
  • Adverse Events (AEs)
  • Serious Adverse Events (SAE)
  • EDC Systems
  • CRFs
  • TMF Management
  • Clinical Trial Operational Documents
  • ICFs
  • Vendor Oversight
  • Team collaboration
  • Regulatory Compliance
  • Audit Readiness

Certification

Certified Clinical Research Associate

Personal Information

Title: LEAD CLINICAL RESEARCH ASSOCIATE

Timeline

Lead Clinical Research Associate

Leadiant Biosciences
01.2020 - Current

Clinical Research Associate

Tasly Pharmaceuticals/Axeon Research Corp
06.2013 - 01.2020

Research Associate

CD Diagnostics
02.2012 - 05.2013

Research Coordinator

Fox Chase Cancer Center
06.2011 - 01.2012

Scientific Technician

Fox Chase Cancer Center
06.2010 - 05.2011

B.S. - Biochemistry & Cellular and Molecular Neuroscience

Temple University

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HELINA TADESSE