Antonella Ferrara (anto.ferrara@libero.it)
Pubblicazioni

Summary
Ms. Ferrara is a experienced clinical research professional with experience as a CRA gained over 2 years in the industry within the CRO. She has worked for six years in Department of Biomedical Sciences, University of Siena, Italy and Department of Pediatrics & Pharmacology, Cardiovascular Research Group, University of Alberta, Edmonton, Canada, as Researcher and lecturer in Pharmacology.

Key therapy experiences are within Neurology Disease, Cardiovascular, Oncology and Pain studies gained within the CRO and University. She has a wealth of experience spanning a range of therapeutic areas,
clinical trial phases and functions.

Ms. Ferrara assisted with development of study related materials, prepared and maintained regulatory documents, notified IRB of SAE/AEs as well as written capsule summaries, monitored recruitment goals,
wrote and revised SOPs, tracked metrics, monitored quality assurance and developed source worksheets. She has also served as a line manager for clinical staff, and was responsible for mentoring, training, and evaluating staff performance.

More details are summarized below:
Therapeutic Experience
Therapeutic experience includes:
Alzheimer's Disease and Neuropsychiatric Symptoms
Huntington Disease
Gastric cancer
Hepatocellular Carcinoma
Metastatic Breast Cancer
Prostate cancer
Chronic Hepatitis
Rheumatoid Arthritis
Relapsing-remitting Multiple Sclerosis
Septic shock
Bioavailability phase I study

Professional Experience

PAREXEL International s.r.l.
Milan, Italy
Aug 2010 - present
Clinical Research Associate

In accordance with ICH Guidelines, current monitor guidelines and SOPs.
• Main tasks performed are: sites identification & selection, collection & preparation of documentation for regulatory/EC approvals, contracts review & negotiation, sites activation, monitor at sites, write reports visits and contact regularly the sites.
• Maintain update the Files in house and at site, collaborate with other departments for reporting safety information, source data verify & collect Case Report Forms.
• Follow up and solve data queries, report the progress of the study on a regular basis to the CL / Sponsor, perform site close-out visits & QC of files, follow up on Investigators Payment.
• Attend all study related meetings, TC internal & external. Manage local teams.

Novella Clinical, formerly Matrix Contract Research
Stevenage, Hertfordshire, UK
February 2010 – July 2010
Freelance Clinical Research Associate

• Participates in the investigator recruitment process. Performs initial qualification visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study, both clinically and technically.
• Works with the Study Start-up Group to coordinate activities with the site in preparation for the
initiation of studies. Obtains regulatory documentation for successful implementation, monitoring, and evaluation of clinical trials. Works with Study Start-up Group and site staff to obtain regulatory (IRB/IEC) approval of study specific documents.
• Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF; monitoring activities and study close-out activities.
• Trains site staff on the EDC system and verifies site computer system.
• Conducts periodic site file audits to ensure compliance with GCPs and Novella Clinical standard operating procedures.
• Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site monitoring visits. Performs validation of source documentation as required by sponsor. Prepares monitoring reports and letters in a timely manner using approved Novella Clinical /sponsor forms and reports.
• Documents accountability, stability and storage conditions of clinical trial materials as required by sponsor. Performs investigational product inventory. Ensures return of unused materials to designated location or verifies destruction as required.
• Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification. Works with sites to resolve data queries.
• Reviews protocols, eCRFs, study manuals and other related documents, as requested by Clinical Trial Manager.
• Serves as primary contact between Novella Clinical and investigator; coordinates all correspondence; ensures timely transmission of clinical data with the study site and technical reporting, as requested.
• Assists with final date review and query resolution through database lock.
• Performs study close-out visits.
• Assists with, and attends, Investigator Meetings for assigned studies.
• May serve as mentor for new clinical study monitors.
• Authorised to request site audits for reasons of validity

Dr Group
Rome, Italy
April 2009 – July 2010
Clinical Research Associate

Main activities and responsibilities:
• Preparation and carrying out of initiation, routine monitoring and close-out of clinical sites, and completion of site visit reports
• Verification of GCPs respect at study sites, ensure that the reported trial data are accurate, complete, and verifiable from source documents and that the conduct of the trial is in compliance with the currently approved protocol/amendment(s), and with the applicable regulatory requirement(s);
• Support the Investigators throughout the entire study
• Performing study drug accountability
• Verifying the documentation of the informed consent process for each study subject
• Reviewing the. case report form against the subject's medical record for completeness and accuracy
• Ensuring the filing and maintenance of the required regulatory documents
• Ensuring that non-serious and serious adverse experiences are properly documented and reported
• Support the Project Manager in collection and verification of site specific essential documents
• Reporting of any possible issue to the Project Manager
• Participation in continuing education, attends meetings, discussions and activities

Activities in the Regulatory Approval Department (RAD) and in the Clinical Operations (CO)
Department:
• Cooperation and support in obtaining the ethics approvals and administrative authorisation for Clinical trials (interventional and non-interventional)
• Obtaining information and documents from Ethics Committees (members list, EC regulations/ procedures, Templates and forms, meetings schedule, meetings minutes, etc)
• Obtaining information and documents from local Competent Authorities
• Management and updating of RAD archive
• On the job training as Clinical Research Associate
• Attending trainings on rules and laws regulating the management and monitoring of clinical trials (GCPs, guideline for non-interventional studies, Trial Master Files, Case Report Forms and DR Standard Operating Procedures)
• Shadowing activities with experienced CRAs in their activity, from the visit preparation to the Monitoring Visit Report drawing up.

Antica Farmacia Reale, Rome, Italy
January 2009 - March 2009
Pharmacist

University of Siena, Italy
October 2005 – December 2008
Researcher and lecturer in Pharmacology (Department of Biomedical Sciences)

University of Alberta, Edmonton, Canada
November 2007 - April 2008
Researcher in the Departments of Pediatrics & Pharmacology (Cardiovascular Research Group)

Education

University of Siena (Italy) 2005- 2009
Specialization Courses/Masters:
PhD in Molecular and Cellular Physiology Pharmacology and Toxicology - (Department of Biomedical Sciences)

University of Siena (Italy) 1998- 2005
University Degree (field and date of certificate):
Pharmacy 110/110 cum laude, 28 September 2005

Scientific Lyceum "D. Alighieri" Matera (Italy) 1993- 1998
High School (Institute and year of leaving certificate)
Scientific Lyceum July1998
Professional Membership
Italian Society of Pharmacology