Aida Serra Ribas Email & Phone Number

Spain

Barcelona Y Alrededores

- Clinical research plan design, coordination, execution and development for products under develepment and post-authorization studies with selected CRO in dermo-cosmetic products and medical devices in accordance with desired claims and with applicable regulations.- Implementation and upgrate CEP, CER, PMCF plan and report under MDR.- Selection, negociation and review with CROs, protocol/CRD design and preparation, documentation approval, monitoring, result analysis and final reports under GCP ICH guidelines.

Barcelona, Cataluña, España

Clinical Research Associate in:- International Ischaemic stroke study phase Ib/IIa (151 patients)- International In vitro cardiology study with 404 patients- International Craniotomy medical device study with 60 patients.

L’Hospitalet De Llobregat Area, Spain

Clinical Research Associate and Clinical Trial Assistant in One-site study with 100 patients as well as in study with 12 sites in Spain both in Ophtalmology field.Support in the preparation of protocols, data collection notebooks and informed consent of a clinical study.Support in identifying, evaluating and establishing clinical study sites and closing sites at the end of the study.Technical, logistical and administrative support to the monitoring team in the different studies when they are subcontracted or to the subcontracted CROs.Support for the Clinical Research Manager of the study, carrying out the relevant monitoring tasks from the Promoter's point of view.Supervising and documenting the dispensing of the product under investigation.To protect the confidentiality of subjects, update their information and verify that the investigational product has been dispensed and administered in accordance with the study protocol.To make periodic visits to the facilities, coordinate project meetings and write visit reports.Support in writing, archiving and ensuring compliance with SOPs and local regulations related to clinical studies.Collaborate with the QPPV on issues related to Pharmacovigilance.Support to the QPPV in maintaining SOPs and other essential documents to cover the needs of OPKO Health Spain in the field of Pharmacovigilance.Collaboration in the presentation of studies to the Ethics Committees and Health Authorities.Management and monitoring of contract negotiations.Ensuring full traceability of all essential documents.Support in processing payments to researchers.Preparation and technical support in the preparation of the material required for monitoring.Technical support in clinical and scientific literature searches.Technical support in the preparation of Clinical Evaluation Reports.Technical support in the preparation of technical and clinical training courses for the company's commercial and marketing departments.

L'Hospitalet De Llobregat Y Alrededores, España

CTA in a study with 15 centres in Traumatology field and in a Veterinary study.Technical support in the preparation of protocols, data collection notebooks, informed consent and other basic documentation of a clinical studyTechnical, logistic and administrative support to the monitoring team in the different testsSubmission of studies to Ethics Committees and Health AuthoritiesManagement and maintenance of the department's archiveManagement and monitoring of contract negotiationsEnsure full traceability of all essential documentsSupport to the monitoring team from the Promoter's point of viewSupport in processing payments to researchersPreparation and technical support in the preparation of the material required for monitoring Technical support in the preparation and reporting of adverse effects to Ethics Committees and Health AuthoritiesTechnical support in clinical and scientific literature searchesTechnical support in the preparation of Clinical Evaluation ReportsManagement of administrative matters in the office

Sant Sadurni D’Anoia, Spain

- Care and medical advice- Attention to the public- Theorical and practical knowledge of the software Farmatic

Sant Pere De Ribes, Spain

- Validation of medication- Medication conciliation- Manufacturing magistral preparation, mixes intravenous, cytostatic drugs, nutrition parenteral.- Management of medicines- Detection of errors in medication- Pharmacovigilance- Dispending of medication in dosage unit- Control of narcotic drugs and psychotropic- Dispending of medication ambulatory- Adherence to the treatment of HIV, Hepatitis C and B and biological drugs.

L'Arboç Del Penedès, Spain

One year of experience, I work all the Summers of these periods.- Care and pharmaceutical advice- Control of inputs and outputs of medications. Control of stocks.- Attention to the public- Theorical and practical knowledge of the software Farmatic- Responsible for the personalized systems of medication- Management and control of the system robotic of storage and dispending of medicines.

Lublin, Lublin District, Poland

- Preparation of training internship- Working with experimental animals- Tests of memory in mice

Bachelor Of Pharmacy - Bpharm, Itinerary In Industrial Pharmacy And Pharmaceutical Research

Master Of Science - Ms, Clinical Trials (Xvii Edition)

Medical Device Postguaduate Expert Degree

Curso D'Ensayos Clinicos En Oncologia

42,5h course

Formacion Regulatoria Productos Sanitarios: Como Afecta Cambio Mdr/Ivdr, Productos Sanitarios, 30H Course

Ich E6 (R2), Clinical Trials, 100%

Monitoring Course Of Clinical Trials, Clincal Trials

Surveillance Of Medical Devices

Cosmetovigilance

“X Curso De Farmacovigilancia: Visión General”, Farmacovigilancia

Good Clinical Practices, Ensayos Clínicos