Farha naaz
@farhanaaz1
Clinical Research Coordinator with 3+ years managing Phase III trials, ensuring ICH-GCP compliance, data integrity, and audit-ready sites.
What I'm looking for
I’m a results-driven Clinical Research Coordinator (CRC) with 3+ years of experience coordinating and managing Phase III clinical trials across neurology and autoimmune indications. I’m highly focused on ICH-GCP, regulatory compliance, and maintaining smooth, audit-ready site operations.
I handle end-to-end site responsibilities including Ethics Committee documentation, regulatory binders, informed consent support, patient screening/enrollment, SAE and protocol deviation reporting, and version control of documents. I partner closely with PIs, CRAs, sponsors, and Ethics Committees to keep approval timelines on track and ensure site activation readiness.
On the data side, I enter and verify high-quality eCRF data in Medidata Rave, manage data clarification forms (DCFs) and queries, and support Source Data Verification (SDV) during monitor visits. I also manage Investigational Medicinal Product (IMP) accountability and randomization through Cenduit/IWRS/IRT/YPrime, plus biological sample handling with strong chain-of-custody and GDP practices.
Experience
Work history, roles, and key accomplishments
Clinical Research Coordinator
Nizam's Institute of Medical Sciences (NIMS Hospital)
Nov 2022 - Present (3 years 7 months)
Coordinated Phase III neurology and autoimmune trials by managing regulatory/ethics documentation, patient recruitment and informed consent, and site-level study operations. Entered and verified eCRF data in Medidata Rave, resolved data queries, supported SAE/protocol deviation reporting, and maintained audit-ready regulatory and source documentation.
Medical Record Reviewer
Expansure IT Solutions
Jun 2022 - Oct 2022 (4 months)
Reviewed and summarized patient medical records with accuracy and clarity. Prepared and finalized documentation for medical exams or legal depositions while removing redundant files and proofreading summaries for completeness.
Education
Degrees, certifications, and relevant coursework
Shadan College of Pharmacy
Doctor of Pharmacy (Pharm.D), Pharmacy
Completed a Doctor of Pharmacy (Pharm.D) program in 2022 from Shadan College of Pharmacy under Jawaharlal Nehru Technology University Hyderabad.
Sri Chaitanya Junior Kalasala
Intermediate (Science), Botany, Zoology, Physics, Chemistry
Completed Intermediate studies in 2015 with Botany, Zoology, Physics, and Chemistry.
Sri Vidya Model High School
SSC (Secondary School Certificate), Secondary Education
Completed SSC (Secondary School Certificate) in 2013 (Regular).
Availability
Location
Authorized to work in
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