Clinical Research Coordinator
Tata Memorial Hospital, Mumbai
Clinical Research Coordinator in Medical Oncology, handling Phase II, Phase III, multi center, randomized, clinical trials since last one and half yearClinical Research Experience:PROJECTS UNDERTAKEN*:a. Multicenter, randomized, double-blind, Phase III trial to investigate the efficacy and safety in patients with stage IIIB/IV or recurrent non-small cell lung cancer after failure of first line chemotherapy.b. A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial for Advanced Non-small Cell Lung Cancerc. An Open Label Randomized Controlled Phase II Study in the Treatment of Patients with Primary Refractory or Relapsed Acute Myeloid Leukemiad. Phase 3 Study of Chemotherapy A, and Radiotherapy Followed by Consolidation Chemotherapy A versus Chemotherapy B, and Radiotherapy Followed by Consolidation Cytotoxic Chemotherapy of Choice in Patients with Unresectable, Locally Advanced, Stage III Non-Small Cell Lung Cancer Other than Predominantly Squamous Cell HistologyRoles & Responsibilities as Clinical Research Coordinator:a. Identification of potential subjects for clinical trials.b. Presenting ICF to the Subject & documentation of detailed process of Informed consentc. Screening, Randomization and Study treatment planning and executiond. Using IVRS & IWRS for treatment allocatione. Source document filing and e-CRF data entry and reconciliationf. SAE compilation, narration and reporting to Sponsor and Ethics Committeeg. Ethics Committee communication for study document submission, safety letters notification, new study submission for approval h. Site master file (SMF) maintenance, IP accountability.i. Sponsor communication for study related issues.j. Representing site during Site feasibility/ assessment, Site Initiation and Site monitoring from the Sponsor