Aline Veiga Email and Phone Number

Clinical Research Monitor* Monitoring field or remote visits to perform drug accountability, ISF review, document collection and all other monitoring activities (all study phases);* Responsible for file (eTMF);* Contacting study sites in order to solve issues and gather pending information;* Responsible for preparing Initiation Visits material (ISF, initial supplies and regulatory documents to sites);* Responsible for customization of contracts and it´s amendments;* Participation on audits.

Monitoring heart valve and stent studies* Monitoring field visits to perform drug accountability, ISF review, document collection* and all other monitoring activities (all study phases);* Monitoring surgery, pre-screening and post-surgery exams;* Preparation of regulatory packages;* Contacting study sites in order to solve issues and gather pending information;* Responsible for preparing Initiation Visits material (ISF, initial supplies and regulatory documents to sites);* Preparation of Notivisa notifications;* Assistance on audits and ANVISA inspection.

· Responsible for the clinical management and for sites support while CRAs were away;· Preparation of regulatory packages;· Contacting study sites in order to solve issues and gather pending information;· Responsible for preparing Initiation Visits material (ISF, initial supplies and regulatory documents to· sites);· Provide day-to-day administrative support to the team;· Maintain central study file for assigned projects;· Tracking study documents in PPD database;· Communicate with investigator, team members and sponsor on various project-related issues;· Receive, prepare and send IND Safety Reports to sites;· Documents translations and reviews;· ICF customization and regulatory submission;· PPD audit file;· Accompanied field visits to perform drug accountability, ISF review, document collection and help on Interim Monitoring Visit Procedures.· Accompanied visits to co-monitor patient charts.

· Provide day-to-day administrative support to the Site Start-up team;· Correspond regularly with team members on various project-related issues;· Track important study data in the PPD database and offered organizational and administrative expertise;· Accountable for the review and transmission of regulatory documents in accordance with FDA, GCP, WPD and SOPs;· Accountable for meeting applicable project timelines in accordance with the master contract;· Perform and coordinate site start-up activities associated with clinical trials to ensure applicable timelines and metrics are met, including all regulatory, legal and financial aspects in accordance with FDA GCPs, ICH Guidelines and Global SOPs;· Coordinate with investigators (physicians), research nurses, study coordinators and/or site administrative staff for completion of required regulatory documents required for site IP approval (in coordination with the required parties: Regulatory Authority, Sponsor, etc);· Collaborate with investigators, research nurses and site staff to achieve issue resolution;· Performs first review and approval of the informed consent form (ICF) draft or IRB approved ICF;· Responsible for ICF negotiations with investigators, research nurses and site administrative staff, remaining in full compliance with ICH-GCP, PPD and sponsor specific requirements;· Negotiate site budgets based on PPD/sponsor requirements and coordinate its dissemination with the legal department;· Compile, assemble and distribute Regulatory packages to sites;· Prepare, submit and/or assist sites with IEC/IRB submissions;· Work with multiple Sponsors and sites simultaneously and performs a variety of start up related tasks, while adapting to changing priorities;