Clinical Process Trainee
Since November 2015
*providing project related assistance for spain,portugal and brazil, regulatory and start-up teams in accordance with the company’s sops, ich-gcp guidelines and local and international regulatory requirements, with special focus on quality and timelines. maintaining administrative systems: *CTMS - documents tracking, maintenance, updating information regarding regulatory authority/ ethical committee/institutional review board submissions, contacts and accounts, susars, Investigator alert letters, Clinical Trial agreements and reports. *assisting local rsu teams with irb / ec submissions (ec/irb), review, preparation and distribution of regulatory documents. *performing essential documents pack release activities (brazil and portugal) including ,but not limited to, documents collection and review for correctness and completeness, Communication with sites where the Clinical Trial will take plce, contracts management – customization, archiving activities, preparation for payments. *Providing project related assistance for Spain,Portugal and Brazil, Regulatory and Start-Up Teams in accordance with the company’s SOPs, ICH-GCP guidelines and local and international regulatory requirements, with special focus on quality and timelines. Maintaining administrative systems: *CTMS - documents tracking, maintenance, updating information regarding Regulatory Authority/ Ethical Committee/Institutional Review Board submissions, contacts and accounts, SUSARS, Investigator Alert Letters, Clinical Trial Agreements and reports. *Assisting local RSU teams with IRB / EC Submissions (EC/IRB), review, preparation and distribution of regulatory documents. *Performing Essential Documents Pack release activities (Brazil and Portugal) including ,but not limited to, documents collection and review for correctness and completeness, communication with sites where the clinical trial will take plce, contracts management – customization, archiving activities, preparation for payments.
ISS CoordinatorAugust 2015 --- November 2015
*support the delivery of osc activities incl. but not limited to preparation, handling, distribution, filing and archiving of Documentation, reviewing study documents for completeness, consistency and accuracy and prepare client deliverable documents using appropriate tools and according to the company sops. *assistance with completion of relevant Clinical Trial Management System (CTMS) fields, Databases, tracking tools, timelines and project plans, interacting with internal and external clients; performing ip release activities on small, straightforward projects or support reviews for larger projects.
European Voluntary ServiceSeptember 2014 --- July 2015
*librarian activities – supervising students coming to the library and lending learning material. *Teaching assistance – role of Consultant with language tasks. *organization of film club – present portuguese movies, followed by a discussion about culture, lifestyle, custom and tradition. *intercultural club – forum on interesting discussions on different intercultural topics. *English conversation group – weekly informal meeting with slovak students where they can improve their English.
Medical Centre ReceptionistJuly 2012 --- August 2014
*schedule and confirm patient appointments *check-in patients, collecting all personal, medical, and insurance information *input all patient information into computer database and file confidentially *proficient in ms office, medical data programs (my Medicine one), and spreadsheets *provide secretarial services such as copying, faxing, filing, sorting mail, etc. *track inventory of office and medical supplies, and place orders when necessary *receive deliveries and put away all supplies in appropriate places
Team Coordinator - Census 2011January 2011 --- January 2011
*Training, supporting and motivating a team of 7 interviewers *receive, check and store bulk supplies *ensuring procedures are followed properly *deal with members of the public and resolve issues.
Tourism Office AssistantApril 2010 --- November 2010
*front desk clerical; compose responses to inquiries. *provide travel information and other services to tourists: greet tourists in person or by telephone, answer questions and give information on historical sites, scenic areas and other tourist attractions. *assist tourists in Planning itineraries and contact tourist operators.
European Voluntary ServiceMay 2008 --- July 2008
*assisting in the daily activities of an youth centre that offers youngsters aged 6 to 19 a range of activities like open minded and detached youth work, counselling, events and holiday programs. *assisting in the organization of the project “europe is more than football” – an intercultural event for teenagers from all over europe.
LinkedIn Assessment :
Bachelor's degree in International Relations - Specialization in Political and Cultural Relations from Universidade do Minho in 2007
Training and Certification
Goethe-Zertifikat A2 in 0000 Certification
Initial Training for Victim Support Officers in 0000 Certification
Youth Pass in 0000 Certification
Youth Pass in 0000 Certification
Area / Region