Roberta Colosimo Email & Phone Number

Italy

Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.Essential Functions• Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Study Start-Up Managers (SSUM), Project Management team, and other departments as necessary. Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.• Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.• Prepare site regulatory documents, reviewing for completeness and accuracy.• Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.• Review and provide feedback to management on site performance metrics.• Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.• Inform team members of completion of regulatory and contractual documents for individual sites.• Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.• Provide local expertise to SSUMs and project team during initial and on-going project timeline planning.• Perform quality control of documents provided by sites.

As CPA, I supported ethical and regulatory submissions for different types of clinical trials and therapeutic areas. Some of the responsibilities for this job:- preparation of essential documents for EC submission;- interaction with EC and clinical staff;- ethical submissions for observational/interventional studies;- TMF management and updating;- Data Management (tracking and resolution of EC queries);- contracts review and negotiation;- ICFs review/customization;- other activities: update meetings, review of clinical protocols, translation of documents related to clinical research.

Quality assurance training (in compliance with D.M. 15.11.2011 – CRO Decree).

CEM responsible in Italy. Working in partnership with an international Clinical Enrollment expert company dedicated to improve patient recruitment in several clinical studies and therapeutic areas. Some of the responsibilities for this job:- contacting experimental centres in order to support them in patient recruitment activities;- building effective relationships with the experimental centres and the staff of the Client; review and discusspatient pathways and patient profiles both internally and with the experimental centres;- provide information on the study protocol to the physicians; review/discuss materials available forexperimental centres and patients, useful for patient recruitment.

Training Assistant for Clinical Research Course “Missione CRA”.

Second Level Master Program - Clinical Research And Medical Affairs. Drugs And Medical Devices

High Specialization Course In Clinical Experimentation "Research Pharmacist & Researcher Pharmacist"

Main Topics: - Reg.(EU) No.536/2014 and Lorenzin Law n.3/2018; - AIFA Clinical Trial Observatory; - Reorganization of the Ethics.

Advanced Training Course In Clinical Research - 50 Hours Course As Per The Dm 15.11.2011

Main Topics: - Methodology and Regulation of clinical trials; - Good Clinical Practice (ICH-GCP); - Standards for Good Manufacturing.

Qualifying Examination To Practice The Profession Of Pharmacist

Master’S Degree In Pharmacy And Industrial Pharmacy, Scuola Di Farmacia E Nutraceutica

Experimental degree thesis "Oral Anticoagulants: evaluation of therapeutic adhesion and follow-up management. Experience in a NAO center"

High School Diploma In Classical Studies, 100/100 E Lode