▪ Ensure study activities are conducted in compliance with the ICH GCP guidelines, company’s SOPs and other applicable regulations;▪ Ensure compliance with all protocol requirements;▪ Ethics Committee and Regulatory Submissions;▪ Perform initiation, site visits, routine and close out visits: CRFs and essential documents review;▪ Queries and issues resolution with site staff;▪ Complete visit report and follow up letters;▪ Contact assigned sites, ensuring adequate enrolment and tracking documents are up to date;▪ Management of adverse events (AE’s and SAE’s) – tracking and follow up;▪ Site monitoring activities in observational studies. Therapeutic Areas:Infection Desease (phase IV) Dermatology (phase IV)

▪ Ensure study activities are conducted in compliance with the ICH GCP guidelines, company’s SOPs and other applicable regulations;▪ Ensure compliance with all protocol requirements;▪ Ethics Committee and Regulatory Submissions;▪ Perform initiation, site visits, routine and closeout visits: Source Data Verification vs CRFs, review essential documents, investigational product accountability;▪ Queries and issues resolution with site staff;▪ Perform unblind monitoring activities (drug accountability, reconciliation, destruction);▪ Complete visit report and follow up letters; ▪ Contact assigned sites, ensuring adequate enrolment and tracking documents are up to date;▪ Management of adverse events (AE’s and SAE’s) – tracking and follow up;▪ Translation of SAE’s;▪ Audits;▪ Coaching CRA trainees.Therapeutic Areas:CardioMetabolic (phase III) Oncology (phase III) Pneumology (phase II)Rare Diseases (phase IV)

▪ Ensure study activities are conducted in compliance with the ICH GCP guidelines, company’s SOPs and other applicable regulations;▪ Ensure compliance with all protocol requirements;▪ Ethics Committee and Regulatory Submissions;▪ Perform initiation, site visits, routine and closeout visits: Source Data Verification vs CRFs, review essential documents, investigational product accountability;▪ Queries and issues resolution with site staff;▪ Perform unblind monitoring activities (drug accountability, reconciliation, destruction);▪ Complete visit report and follow up letters; ▪ Contact assigned sites, ensuring adequate enrolment and tracking documents are up to date;▪ Management of adverse events (AE’s and SAE’s) – tracking and follow up;▪ Translation of SAE’s;▪ Support in Audits (preparation).Therapeutic Areas:CardioMetabolic (phase III)Pneumology (phase II)Rare Diseases (phase IV)

▪ Submissions to the Ethics Committee and Health Authority;▪ Preparation and maintenance of clinical investigator files and documentation;▪ Preparation of monitoring visit documentation/material;▪ Translation of informed consent, protocol synopsis, Health Authorities letters, patient cards, patient diaries;▪ IP management.

▪ Submission of variations for medicinal products;▪ Launch, validation and approval of packaging materials;▪ Translation of centralized procedures texts;▪ Update of international databases;▪ Contact with the health authority and health professionals.

▪ Customer Service;▪ Validation prescriptions;▪ Medication verification;▪ Reception and medicines storage and stock management of the several services.

▪ Participation and organization of an activity under Day Heart "The Pharmacist in the prevention of your heart"▪ Promotion of homeopathic medicines.▪ Customer Service;▪ Control and monitoring of biochemical parameters.

Monitor in practical classes of Pharmacognosy (3th year of Pharmaceutical Science MSc Degree)