Caroline VALLEE

Gastroenterology, Pneumology, Nephrology:

In close collaboration(and supervision) with the PI:

• Implementation of clinical research projects at site: reading and training of protocols, participation in site selection and SIVs, creation of source documents, orders and management of equipment.
• Recruitment and participants visits: presentation of the research project and the ICF to potential subjects, review of medical files, organization and carrying out of visits patient(carrying out specific procedures to the protocol and SOPs, evaluation of AE-SAE, CM, administration of the study medication, maintenance of source documents and e-crf, mangement and shipment of biological samples)
• Updating e-crf and crf, reporting AEs and SAEs.
• File and maintain regulatory documents.
• Implication in ICF adaptation and ethic submission process.
• Management of monitoring visits.

• Sponsor dedicated Astrazeneca Biopharm
• Monitoring of clinical trial activities in compliance with FDA regulations, ICH/GCP guidelines, company SOPs, Handbook monitoring, and as stipulated in the monitoring plans for assigned projects.
• Support recruitment and retention plan at site level, track subject and enrolment status, identified issues and support study team for resolution.
• Document follow-up activities/outcomes in timely manner (monitoring reports).
• Report/track adequately AEs SAEs, protocol deviations and subject status
• Work effectively with investigators and other research personnel, to maintain a professional demeanor and good relationship.
• Workload priorization to meet project timelines.

Covid-19, neurology, cardiology, gastroenterology, pneumology, hematology, radio-oncology

In close collaboration(and supervision) with the PI:

• Implementation of clinical research projects at site: reading and training of protocols, participation in site selection and SIVs, creation of source documents, orders and management of equipment.
• Recruitment and participants visits: presentation of the research project and the ICF to potential subjects, review of medical files, organization and carrying out of visits patient(carrying out specific procedures to the protocol and SOPs, evaluation of AE-SAE, CM, administration of the study medication, maintenance of source documents and e-crf, mangement and shipment of biological samples)
• Updating e-crf and crf, reporting AEs and SAEs.
• File and maintain regulatory documents.
• Implication in ICF adaptation and ethic submission process.
• Management of monitoring visits.

Pneumology:

In close collaboration(and supervision) with the PI:

• Implementation of clinical research projects at site: reading and training of protocols, participation in site selection and SIVs, creation of source documents, orders and management of study equipment.
• Recruitment of study participants.
• Preparation of study visits:
• Monitoring and updating e-crf and crf, reporting AEs and SAEs.
• File and maintain regulatory documents.
• Implication in ICF adaptation and ethic submission process.
• Management of monitoring visits.

• Supervision of nursing students on their internship site and Assessment of students' practice and their progress.
• Teaching nursing techniques and theoretical content.

Department of Pneumology and Cystic Fibrosis

• Management of hospitalized patients, in collaboration with the multidisciplinary team.
• Patient evaluation, application of protocol and prescription, and maintain of patient's files.

• Monitoring the overall progress of a group of patients, in collaboration the medical team.
• Managing problems and conflicts inherent in a care unit.

• Overall management of 3 patients with multi-organ failure, with hemodynamic monitoring and organ replacement
• Participation in the drafting of care procedures, and supervision of students

• Provide hygiene and comfort care to patients
• Support for families