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Nuzhat Hussain

Nuzhat Hussain

CLINICAL RESEARCH ASSOCIATE | CLINICAL TRIAL OPERATIONS | SITE MANAGEMENT

Tampa, HillsboroughMember since September 10, 2023
Clinical Trial OperationsSite ManagementStudy Start-UpSite ActivationRegulatory & IRB SubmissionsFDA / ICH-GCP ComplianceSource DocumentationEDCCTMSData Quality & Query SupportSafety ReportingIP AccountabilityRecruitment & RetentionProtocol ComplianceAudit ReadinessCAPA / Quality SystemsSponsor / CRO CommunicationVendor CoordinationTeam Training & OversightFibroScan assessmentsPhlebotomyEKGs
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About

SOCRA Certified Clinical Research Professional and MBBS-trained clinical research professional with 5+ years of experience supporting Phase II–IV clinical trials from study start-up through closeout. Strong site-level expertise in regulatory submissions, IRB documentation, site activation, participant recruitment and retention, informed consent, source documentation, EDC, safety reporting, investigational product accountability, and audit readiness. Experienced primary liaison to sponsors, CROs, investigators, and vendors across hepatology/NASH-MASH, gastroenterology, neurology/stroke, pulmonary, cardiology, and women's health.

Seeking to transition site-level clinical research expertise into a Clinical Research Associate role.

Experience

Lead Clinical Research Coordinator / Site Operations Lead - Theia Clinical Research Center

(2024-05)

  • Lead end-to-end execution of Phase II–IV clinical trials, coordinating study activities from start-up through closeout.
  • Coordinate study start-up, regulatory submissions, IRB documentation, site activation, and ongoing protocol compliance.
  • Serve as a primary liaison among sponsors, CROs, investigators, vendors, and site teams to resolve operational and study-related issues.
  • Manage participant recruitment, informed consent, study visits, safety reporting, investigational product accountability, and data integrity.
  • Maintain inspection and audit readiness through timely EDC completion, source documentation, quality oversight, and adherence to FDA, ICH-GCP, and IRB requirements.
  • Train and mentor coordinators and support staffing, workflow optimization, vendor coordination, and day-to-day site operations.

Clinical Research Coordinator - Synergy Healthcare

(2023-12 - 2024-05)

  • Managed clinical research operations, participant coordination, protocol compliance, FibroScan assessments, and quality assurance.
  • Supported accurate study documentation and coordinated participant activities in accordance with protocol requirements.

Obstetric Nurse - The Woman's Group

(2022-08 - 2023-11)

  • Performed clinical assessments, phlebotomy, NSTs, assisted procedures, maintained medical records, and coordinated patient care.

Lead Medical Assistant - Qvita Health

(2022-04 - 2022-08)

  • Supervised clinical workflows, trained staff, performed EKGs, and coordinated patient care.

Medical Intern - Bangabandhu Memorial Hospital

(2016-11 - 2018-07)

  • Completed clinical rotations, patient care, surgeries, emergency response, and research support.

Education

MBBS - Bachelor of Medicine & Surgery - University of Science and Technology Chittagong (2018)

Skills

CLINICAL RESEARCH ASSOCIATECLINICAL TRIAL OPERATIONSSITE MANAGEMENT

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