Bruna De Abreu Crippa

Experience

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  UNIFESP

  Jan 2008 - Nov 2011

  Clinical Study Coordinator at NUPEQ/UNIFESP

  Act as a primary contact coordinating clinical trials, interacting with many sponsors and CROs. Responsible for SUSAR (Suspected Unexpected Serious Adverse Reaction); Responsible for Clinical Trial SAE (Serious Adverse Event) and regulatory reporting to Ethics Committee (CEP).Preparation and submission of regulatory package, development of documentation for shipment of biological samples abroad (IATA certificate); Responsible for insert patient data on EDC ans query resolution (CRF user); Supplies/ IP accountability and storage (IVRS user).Responsible for internal monitoring to ensure the best conducting of a clinical study. Active participation on PSV, SIV, IMV and COVs.Clinical Research development projects:03 Clinical Trials - phase III (Diabetes Type 2) – 2007 - 201101 Clinical Trial - phase IV (DiabetesType 2) 2008- 201002 Clinical Trials - phase IV (Vaccine - Influenza) – 2009 - 201001 Clinical Trial - phase III (Anxiety) - 2008- 200901 Clinical Trial – Phase III (Atherosclerosis)- 2008 – 201202 Clinical Trial – Phase III (Alzheimer’s disease)- 2008- 201101 Clinical Trial – Phase IV (Thromboembolism) – 2008 – 201001 Clinical Trial – Phase III (Diabetes Type 2) – 2010 – 201201 Clinical Trial – Phase IV (Influenza) – 2009 – 201001 Clinical Trial – Epidemiological (Herpes Zoster*) -2008-2011*Publishing a scientific paper of Herpes Zoster epidemiological study, presented at the World Congress of Post Herpetic Neuralgia in Athens (Third International Congress on Neuropathic Pain/NeuPSIG 2010).**Publishing a scientific paper of Herpes Zoster epidemiological study on national scientific magazine on Brazil.-Knowledge of ICH-GCP, FDA & local regulatory requirements-EDC Data Capture and IVRS user of all clinical trials;-Pending queries resolution with medical team;-Regulatory Affairs (Safety Letters Report, CEP, CONEP, ANVISA);-Follow-up monitoring visits.-Investigator's meeting participant. Show less

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  PPD

  Nov 2011 - Jun 2014

  Project Assistant, Clinical Management

  Provide day-to-day administrative support to the team; Maintain central study files for assigned projects; Possess the ability to conduct investigator file reviews; Correspond regularly with investigators, team members and sponsors on various project related issues; Track important study data in the PPD database and offered organizational and administrative expertise; Internally co-monitoring all site issues; Interim Monitoring Visits experiences with CRAs (co-monitoring); Performance of Monitoring visit reports and follow up letters experiences; Files maintenance and clinical management with CRAs; Investigator’s Meeting organization; Developing minutes of Sponsor’s Global Calls; Lead Project Assistant of Latin America; All trainings required by CRO completed; Accountable for the review and transmission of regulatory documents in accordance with FDA, GCP, WPD and SOPs; Active experiences with data management, project view, study metrics, investigator’s payment, reconciliation process, team management.Clinical trial experience while Project Assistant: 06 Clinical Trials of 3 different therapeutic areas, all studies are ongoing. Show less

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  Novartis

  Jun 2014 - Sept 2022

  Global Drug Development (GDD) - Trial Monitoring BrazilMain responsibilities:- Project Management- Feasibility, allocation, start up activities, initiation and conduct of trials - Delivery of quality data and compliance to quality standards- Budget and productivityDay to day planning, executing and reporting, (from site feasibility up to and including study site close-out), of assigned Innovative Medicines Phase I-IV studies in compliance with internal processes and regulatory requirements. Single point of contact and local study team lead for the assigned studies. Responsible for assuring aligned communication with CRAs, CRA Managers and other key Country associates on the execution and progress of their studies. Accountable to communicate with and support relationships with clinical investigators. Collaborates with Country medical/clinical trial colleagues on the execution and delivery of their assigned studies.*Experience in managing trials in the following Therapeutic Areas: cardiovascular, nephrology, dermatology, immunology, rheumatology, rare-diseases, neurology, psychiatry, hematology, oncology (breast cancer, lung cancer, melanoma and thyroid). Show less Global Drug Development (GDD) - Trial Monitoring BrazilMain responsibilities:- Provides day-to-day support to country Field Monitors in the areas of monitoring processes and procedures, and systems- Supports audit organization & inspection preparation working closely with the local and regional teams- Supports global initiatives in various capacities- Participates to continuous process improvement discussions to increase quality, speed and productivity in trial execution- Identifies monitoring risks through the analysis of audit and inspection findings- Implements issue identification and root cause analysis to troubleshoot systemic issues in country and help them resolve through new or enhanced processes and training- Contributes to the development and implementation of new tools, processes and Operational Excellence initiatives Show less

  • Clinical Study Manager

    Aug 2019 - Sept 2022

  • Training & Compliance Manager (Job Rotation)

    Mar 2019 - Jul 2019

  • Sr Clinical Research Associate (and Sabbatical as GCP Auditor in GQA)

    Jan 2018 - Jul 2019

  • Clinical Research Associate II

    Nov 2016 - Jan 2018

  • Clinical Research Associate I

    Jun 2014 - Nov 2016
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  MSD

  Sept 2022 - now

  Senior Clinical Research Manager, Global Clinical Trial Operations

  CRM - GCTO BrazilActing as Therapeutic Area Lead for Cardiovascular, Vaccines, OncoPed and Head & Neck portfolio.Mentoring of new Project Managers.Responsible for portfolio delivery at county level.