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Hena Kauser

@henakauser

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Manager, Clinical Research with 7+ years leading GCP trials across oncology and immunology.

United States

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What I'm looking for

I’m looking to lead clinical trials end-to-end with strong GCP/IRB/FDA compliance—driving operational excellence, cross-functional collaboration, and quality processes across oncology and immunology studies.

I’m a Certified Clinical Research Professional (CCRP) with 7+ years of experience in clinical trial coordination, study life-cycle management, data management, and regulatory compliance. I specialize in oncology and autoimmune/immunology-focused studies, executed with strong GCP, IRB, and FDA adherence.

I lead cross-functional teams and have successfully managed and led 12+ clinical trials from study start-up through close-out. I direct feasibility assessments, regulatory submissions, site activation, patient recruitment, vendor coordination, and monitoring visit readiness to keep studies on track.

I bring operational depth across start-up, enrollment, and oversight—handling subject screening and informed consent, AE/SAE documentation, and audit-ready regulatory files. I also support staff training, SOP implementation, onboarding, and quality assurance initiatives to maintain consistent performance.

Along with clinical operations, I manage study trackers and stakeholder communication, and I handle budget negotiation, clinical trial agreement (CTA) review, contract management, and CRO/vendor management. My background also includes data/reporting and clinical coding, which strengthens my focus on accuracy, compliance, and quality.

Experience

Work history, roles, and key accomplishments

Current

Manager, Clinical Research

Current

Arnold Arthritis and Rheumatology

Aug 2024 - Present (1 year 10 months)

Oversaw cross-functional coordination across investigators, sponsors, CROs, vendors, and site staff to execute oncology and immunology clinical studies in compliance with GCP, IRB, and FDA regulations. Managed study life-cycle activities and led 12+ trials from start-up through close-out, including startup, regulatory submissions, patient recruitment, vendor management, and audit-ready documentati

Clinical Trial Management GCP Compliance IRB Submission Study Start Up Vendor Management EDC Systems Regulatory Documentation Audit Readiness Cross functional Leadership

Senior Oncology Coordinator

Avicenna Clinical Research

Jun 2023 - Jul 2024 (1 year 1 month)

Coordinated end-to-end oncology clinical trials while ensuring protocol compliance with IRB, GCP, and SOPs. Managed patient recruitment and consenting, maintained EDC data, and supported site initiation, visits, and audit/inspection readiness.

Oncology Clinical Trials GCP Compliance IRB & SOP Adherence Patient Recruitment AE SAE Documentation Site Initiation Cross functional Coordination

Data and Reporting Analyst

Accellacare / ICON PLC

Apr 2021 - Jan 2022 (9 months)

Developed and validated clinical reports to monitor trial performance and compliance. Tracked clinical data metrics for QA/QC, ensured timely and complete regulatory documentation aligned with SOPs, and supported data discrepancy flagging.

Clinical Reporting Data Validation Regulatory Documentation Compliance Monitoring SOP Alignment Data Integrity

QA/QC Analyst

Religent Pharmaceutical Labs Pvt. Ltd.

Feb 2014 - Dec 2016 (2 years 10 months)

Performed chemical and analytical quality testing on pharmaceutical compounds and ensured documentation readiness for audits. Managed regulatory data entries to support QA/QC and compliance requirements.

Pharmaceutical QA QC Regulatory Documentation Audit Preparation Compliance Support

Medical Data Coder

Infinx Pvt. Ltd.

Mar 2013 - Feb 2014 (11 months)

Coded clinical records and insurance claims using CPT and ICD-9/10 to support accurate billing. Validated claims for billing accuracy in alignment with payer guidelines.

CPT Coding ICD 9 Medical Coding Clinical Records