Chinedu Ochin, (MD. PhD)

Experience

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  Core Laboratory Center for Population Health.

  May 2018 - May 2021

  Postdoctoral R&D Clinical Scientist

  ■ Served as a process optimization expert that has trained several undergraduate/graduate students and laboratory professionals on basic/clinical/molecular epidemiology and observational methods, interventional and randomized controlled trials, evidence-based medicine, research, specifically implementing a funded research project, setting up a system for data collection and its later analysis.■ Technical transfer skills maintained through knowledge of epidemiological, clinical, molecular, and bioanalytical laboratory programs, equipment, operations and administrative policies and procedures, which facilitated the collaboration and management of ad-hoc CROs and external vendors.■ Astute documentation and reporting skills that was applied to performed scientific research that involved the reception of population biologic materials, sample preparations, processing, and the performance of biochemical and molecular analysis of over 20 different biomarkers along with its attendant clinical pharmacology and safety data for the Boston Puerto Rican longitudinal Health Study.■ Identified process pain points gained as a strategy analyst in the standardization of sample collection procedures, transport, dissemination, and delivery implementation of over 20 standardized postoperative protocols.■ Performed and ensured device safety, quality control and quality assurance checks on investigational and imaging biomedical devices such as Magnetic resonance systems (NMR and MRI), Chromatography and Mass Spectroscopy systems (HPLC, GCMS, LCMS), Microscopic Systems (SEM, TEM, Fluorescence, Photon-Confocal, Flow-Cytometry) required for the investigation of cardiovascular, neurology and oncology biomarkers. Show less

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  Matrix Formations and Solutions CRO, a subsidiary desk of Rock Healthcare Services Ltd

  Jun 2021 - now

  Principal Scientist.

  ■ Review, analyze and Interpretation of clinical trial data through successful implementation of translational research principles which involves the application of basic science bench research and discoveries to relevant/pertinent clinical bedside challenges and problems which leads to the successful development of presentations, abstracts and publications emerging from the clinical studies.■ Provision of strategic recommendations for FDA regulatory documents submission that is required for all stages of assigned trial lifecycle such as IDE, IND & NDA documentation, HA briefing books, BLAs, and Orphan Drug Applications with the aim of coordinating and liaising with the various collaborating clinical development teams (clinical operations, data management, biostatistics, and regulatory teams).■ Medical writing experience and reporting through scientific research that involves the review of scientific literature, database analyses, preparation of clinical study reports & regulatory submissions, drafting consents and protocols along with the development, planning and implementation of patient treatment programs that enables the proper preparation for key study meetings (investigator meetings, monitoring committiees, and advisory boards).■ Skilled and compliant with the best practices approach in the respective aspects of the four regulatory affairs of GxP “Good Practices” quality guidelines and regulations as applied to clinical (ICH/GCP), manufacturing (GMP), distribution (GDP), and laboratory (GLP) as per the standardized dictates of the FDA and EU regulations that is used to meet regulatory requirements and ensure strict adherence to clinical study SOPs. ■ Provision of clinical, compliance and cross-functional input and recommendations required for the implementation of assigned clinical trial(s) through aspects such as investigator selection, patient recruitment, feasibility questionnaire, training PowerPoints, and supporting Ethics committee submissions. Show less