Francesca Del Piano

Assembly and setup of drug and supplement displays in pharmacies in the provinces of Rome and Viterbo.

• Monitoring activities in ginecological oncology clinical trial
• training and support to physicians of the hospital and the site staff involved in the trial

• Perform Investigator feasibility and capability assessments to support site evaluation: e.g. phone contacts, questionnaire in the appropriate country
• Serve as single point of contact with the site to collect and review site documents which will be used for both CA/EC submissions and Approval to ship IMP; ensure quality and accuracy of documents in accordance to ICH/GCP and local regulations, requirements and guidelines.
• Support initial and ongoing CA/EC submissions as well as contract and budget negotiations and payment processes, as requested
• Conduct of site qualification visits (pre-study visits), site initiation visits, interim site visits and site close out visits, in accordance to SOPs, ICH/GCP
• Follow Protocol(s)/Amendment(s), Standard Operating Procedures (AC and CSL SOPs) Code of Federal Regulations (CFR) Good Clinical Practice (ICH GCP), and local regulation
• Coordinates between site and appropriate contacts to ensures the site is equipped with all necessary supplies to perform study procedure
• Ensures all project specific training is conducted and documented for the site throughout the life of the trial and coordinates between site and applicable parties to ensure sites have all applicable study required accesses
• Preparation and/or review of any kind of study documents, Monitoring Guidelines, CRF Completion Guidelines, Patient Information and Informed Consent Form etc.
• Trains on and adheres to the Monitoring Plan
• Support creation of materials as needed to successfully execute assigned responsibilities, as needed
• Writes visit reports and corresponding site visit confirmation and follow-up correspondence for all site visit types
• Perform Lead CSA activities on a project as needed and assigned
• Attend team meetings as needed for the clinical trial
• Ensure data quality of assigned sites, by performing source document verification, source data review, review regulatory documents and investigational product, and prepare trip reports as outlined in the Monitoring Plan
• Responsible for regular communication to the site and follow-up and resolution of all site questions, issues, concerns, including but not limited to protocol questions, visit follow-up items, queries, action items, protocol deviations, etc.
• Ensures site visits are scheduled and conducted in accordance to the Clinical Monitoring Plan (schedule and activities).
• Maintains awareness of key study performance indicators for assigned sites including subject recruitment and retention strategies
• Responsible for regular communication and escalation to the study team (e.g., Lead CSA) regarding site status, issues, etc.
• Responsible for maintaining relationships with and serve as single point of contact for communications with all site staff including the Principal Investigator, sub-Investigations, Study Coordinators, Pharmacist(s), Laboratory Personnel, etc.
• Responsible for IP accountability and proper maintenance of IP processes and documentation at the site
• Perform co-monitoring visits and/or mentoring as assigned
• Ensures all assigned sites are trained and compliant with requirements of the study protocol, informed consent process, data collection requirements, IP management, SAE reporting requirements
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness. Reconciles the ISF with the Trial Master File (TMF) to ensure audit readiness, including filing of all applicable documents
• Supports site audit and inspection activities as needed
• Participates in and completes all relevant job/study related trainings
• Performs activities in other clinical research areas according to the directive of superior

• CRA for international multi-centre Phase I-IV clinical trials with monitoring functions, Good Clinical Practices, and relevant regulations.
• Certified as per DM 15Nov2019

• Monitoring of international clinical studies: initiation, monitoring and closure in accordance with the appropriate quality standards including ICH-GCP guidelines, SOPs applicable regulations, rules and guidance.
• Maintenance of study documents.
• Clinical site start-up phase support.
• Clinical trial management activities.
• Mentoring and Training of less experienced CRAs.
• Regulatory officer (start date: 4 Jul 2018).

• CRA for international multi-centre Phase I-IV oncology and dermatology clinical trials with monitoring functions, Good Clinical Practices, and relevant regulations.
• Main activities:
• Management of study site activities to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines and Standard Operating Procedures and Project Specific Operating Procedures
• Site feasibility and site identification process
• Submission to Ethics Committees and Local Authorities
• Contract negotiation
• Set-up of Investigator Site Files
• Maintenance of study-specific project tracking tools
• Collection and review of regulatory documents to assure compliance with Good Clinical Practices, FDA / ICH requirements and local regulation
• Site Selection visits, Initiation Visits, Interim Monitoring Visits and Close-Out Visits
• EDC systems – data verification, tracking and resolution of data queries
• IWRS/IVRS systems use
• Management of project-related electronic files and maintenance of a Trial Master File

• Study start-up associate
• Main activities:
• Takes responsibility for quality deliverables at the country level for site start-up in one or more components.
• Follows project requirements and applicable country rules.
• Proactively forecasts submission/approval timelines and ensures they are adhered to. If forecasted timelines are not reached, provides clear rationale for delays, provides contingency plan to mitigate impact, and escalates the issue as soon as identified.
• Prepares and submits Central EC/IRB Applications, Local EC Applications, RA Applications, and other local regulatory authorities or hospital approval submissions as required.
• Prepares ongoing submissions, amendments, and periodic notifications required by central and local EC and RA, and other local regulatory authorities as needed within the country; includes safety notifications as required by local rules. May provide regular updates of country specific information on the clinical trial application database on SharePoint. Submits end of study notifications to Regulatory Authorities, Ethics Committees/Review Boards and other local authorities in the specified country according to national timelines.
• Performs essential document collection and review, ensuring that sponsor and investigator obligations are being met and are in compliance with applicable local regulatory requirements and ICH/GCP guidelines.
• Local Investigator Contract and budget negotiator - produces site-specific contracts from country template. Submits proposed contract and budget for site. Negotiates budget and contract with site and via Contracts Lead with Sponsor until resolution of issues and contract execution.
• Prepares checklist for IP release according to country regulations.
• Ensures accuracy and completeness of trial master file documents submitted during start-up and performs a QC review of files before transfer to Maintenance for filing in TMF.
• Provides all regulatory documents and relevant study correspondence along with translations to study maintenance at end of start-up.
• Collects information on submission deadlines and timeline metrics for Regulatory Authority, Ethics Committees, Investigational Review Boards and other local bodies as appropriate.
• Liaises with internal team members to review areas that impact study start-up and shares start-up information with the project team.
• Provides country-level intelligence on site start-up. Ensures that local country regulatory intelligence is maintained on the central repository, e.g. Competent Authority submissions, EC submissions, notifications to data protection authorities, notifications/applications to any other local/federal/national body, and import/export license applications where these are obtained with RA applications.
• Sets up and maintains a country folder with country Ethics Committees/Review Board and local authority addresses and requirements.
• Pending country in use, the SSUA may set up and maintain details of existing site and institution contract requirements, as well as the necessary templates and fees, on the clinical trial application database on SharePoint.
• Provides quality review of the informed consent and adapts the template as appropriate.
• Works within the scope of Clinical Management Plan (CMP), study processes, ICH-GCP and/or ISO14155 and any other requirements mandated by the study.
• Ensures documentation of QC of eTMF from the Study Start-Up phase or other sections where the Start-Up Associate is acting as document owner as the final deliverable to the client.
• May support preparation of specific start-up strategy for projects at the proposal stage to support business development opportunities.
• Provides training for local affiliate employees and other applicable internal teams for changes in country specific regulations for clinical trials.
• Reviews and advises on Regulatory and Clinical Operations SOPs, WGs and ADs related to Study Start-Up and regulatory tasks or country specific pharmacovigilance reporting requirements.

• Clinical Trial Manager
• European Clinical trial manager for global international multicentre studies in oncology and rare disease, supporting the International Project Manager in accordance with contracted services, current legislation, ICH GCP and appropriate company/ Sponsor procedures.
• Main activities:
• Support the clinical start-up and monitoring teams with focus on deliverables
• Supports Project Management in the development and review of the protocol/study design, case report forms, informed consent forms and other documents
• Plans and conducts initial and ongoing training for the study team on project-specific matters and enlists therapeutic assistance where applicable
• Assists the project team in the creation and maintenance of the Trial Master File according to Premier Research or client SOPs
• Develops a clinical monitoring plan as well as clinical monitoring tools
• Prepares and executes a site and patient recruitment and retention plan
• Drives the successful activation of trial sites according to time, quality/scope and budget parameters
• Serves as initial point of contact for all clinical management and monitoring issues, vendors and other functional areas, escalating as required
• Ensures effective communication plans are in place for the clinical team and are actioned
• Monitors the preparation and timely completion of all monitoring visit reports, reviews them for appropriate content, and ensures effective follow up and resolution of site issues
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
• Works with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk
• Works with the Project Manager (PM) to ensure transparent and proactive sponsor and internal communication regarding study progress and trial issues
• Escalates issues and provides escalation path for the team
• Attends project reviews and customer meetings as required
• Supports study audits and responds to audit reports
• Performs any other duties required to ensure the success of the trial and Premier Research Prepares forecasts for staff utilization over the life of the study
• Works with the PM and appropriate line managers to ensure team members are adequately assigned to the project and the project is appropriately resourced over project duration
• Assists the PM to ensure appropriate transition planning and stakeholder communication for any change in staff
• Provides Time Entry Guidelines to the clinical staff, and applicable training
• Identifies out-of-scope tasks from the clinical team and ensures pre-approval of these tasks
• Identifies, recruits and manages central vendors as required per project scope
• Provides performance feedback on project team members for annual appraisals
• Mentors and trains junior level staff
• Acts as a resource for other CMs and seeks opportunities to share knowledge-base
• Participates in corporate initiatives and actions that ensure the continued success of the company
• Serves in dual CM/PM role on smaller, clinical-only studies as require
• Other activities as designated

• Lead CRA and Senior CRA:
• Lead CRA support to PM for cardiovascular and oncology global international multicentre studies.
• Main activities:
• Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member
• Works with the Data Management team to identify data related issues and risks to clinical activities; assists in the development of mitigation plans to minimize risk
• Clinical oversight and accountability for project assigned CRA teams - drive protocol compliance, monitoring activities oversight; report review; ensuring of high quality in data collection, query resolution; issue tracking, escalation and resolution; education of CRAs on query/issue trends and mitigation strategies; oversight of SAE reporting and SAE query resolution
• Coordination of the activities around DB lock
• Training and accompanied MVs of monitoring teams and development of junior colleagues

• CRA for global multi-centre Phase I-II-III clinical trials, monitoring functions, Good Clinical Practices, and relevant regulations. Experience includes all the phases from feasibility to close out visits at sites located in Italy, Switzerland and Spain further to audit preparation and CAPA plan resolution.
• Main activities:
• Responsibilities include identification, selection, initiation, and close-out of appropriate investigational sites for clinical studies. Monitor those sites in order to ensure that studies are carried out according to the study protocol, CRO SOPs/WPs, applicable regulations and the principles of ICH-GCP
• Planning day to day activities for monitoring of a clinical study and sets priorities per site
• Preparation for and conducts on-site qualification, study initiation, interim monitoring and close-out monitoring visits at investigator sites
• Performing audits and provide CAPA plan resolution
• Planning day to day activities for monitoring of a clinical study and sets priorities per site