Gisela Rocha Email & Phone Number

Porto Area, Portugal

Porto Area, Portugal

Overall coordination and management of clinical studies, or projects of other nature.Responsible for owning and achieving contractual deliverables for assigned projects/programs, according to the time, quality/scope, and cost constraints. Leads and directs cross-functional teams as well as understands/manages client expectations and needs to achieve client satisfaction.Applies professional principles, practices, and techniques to lead project teams and control project schedule, costs and performance risks in compliance with applicable legal and regulatory requirements, Good Clinical Practices (GCP), applicable Standard Operating Procedures (SOPs) and business ethics.

Porto Area, Portugal

Ensure compliance with applicable legal and regulatory requirements, clinical trial protocol, BLCL Standard Operating Procedures (SOPs), ICH Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).Manage laboratory equipment and material consumables.Liaise with external laboratories in charge for clinical laboratory safety analysis.Provide training to BLCL-PHI staff as assigned by management.Develop and/or maintain tracking tools for clinical projects as assigned by management.Support clinical trials’ preparation and conduction. Since January 2015 is also closely involved in certain management and operational tasks, more related to the Clinical Research Manager role, including, but not limited to:- Overseeing adequate Blueclinical Phase I Unit adequate functioning;- Overseeing clinical trial operations and reporting activity status to Clinical Operations Director;- Recruiting and training Phase I team;Liaising with Blueclinical Phase I partners, service providers and regulatory authorities.

Porto Area, Portugal

- Technical Administrative - service entrance. - Distribution, labeling and processing all data relating to products for biological analysis. - Support the quality management system.

Porto Area, Portugal

- Help students achieve success, monitoring their work and study during the school year, whether in elementary, secondary, or college/university setting.

Porto Area, Portugal

Management of healthy volunteers’ database and recruitment for pre-screening.Scheduling patient visits and tests, preparing clinical trial material.Handling of all administrative aspects of the studies.Preparation of the Trial Master File (TMF) for Human Pharmacology Unit Phase I Studies and study dossier to submission to Regulatory Authorities and Ethics Committee.Organization and archive of the documentation relating to phase I, II and III studies.Checking the accuracy and completeness of the CRF entries, Source Documents (SD) and other trial documentation against each-other.Organization and verification of clinical consumables Stocks.Preparation of biological samples for clinical safety tests and for pharmacokinetic and pharmacodynamic assays. Transfer samples to the laboratories responsible for analysis.

Porto Area, Portugal

- Processing blood samples.- DNA extraction.

Porto Area, Portugal

- Development and execution of the investigational strategy on the project: “Prevalence of Human Papillomavirus Low and High risk in women-negative and seronegative for human immunodeficiency virus in northern Portugal.”

Project Management

Post-Graduation In Food Safety And Security

Bachelor Of Science In Microbiology