With moderate oversight and supervision, serve as Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager (SAM), Project Management team, and other departments as necessary.Prepare site documents, reviewing for completeness and accuracy.Inform team members of completion of regulatory, contractual and other documents for individual sites.Distribute completed documents to sites and internal project team members.Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.Review, track and follow up the progress, the approval and execution of required documents such as questionnaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents.

Under general supervision, perform site activation activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the Site Activation Manager, Project Management team, and other departments. Review documents for completeness, consistency and accuracy, under guidance of senior staff. Prepare site regulatory documents, reviewing for completeness and accuracy. Inform team members of completion of regulatory and contractual documents for individual sites. Distribute completed documents to sites and internal team members. Support the updating and maintenance of internal systems, databases, tracking tools, timelines and project plans with accurate ad complete project specific information. Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, ICF and IP release documents.

I am maintaining timelines and ensuring accuracy and completeness of data entered into ICON systems.Became familiar with ICON’s SOPs/WPs, ICH GCP guidelines and appropriate regulations. Became familiar with ICON systems, with the principles of and assisting with investigator recruitment.Serving as the primary in-house contact for sites and investigators participating in studies.Conducting and completing remote site management activities, with support as needed, according to applicable SOPs and the Study Monitoring Plan.Contacting Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.Taking responsibility for project tasks, with support.Participating in QA Audits as needed.

Ensure all work is conducted in accordance with IQVIA / Customer SOPs, policies (as agreed), Good Clinical Practices and applicable regulatory requirements.Ensuring filing accuracy and compliance to IQVIA or Customer File Plans and SOPs.Ensure project deadlines, commitments, and goals are met with Quality.Serve as the liaison between Records Management and Internal user departments regarding Trial Master Files.Monitor and assist in the preparation of closed studies for transfer to clients per agreed due dates.Apply Records Management expertise to provide project related assistance across and multiple project(s), and project teams. Hardcopy documents to be Pre-QCed and scanned within agreed timelines and Matrix Tool.All procedures associated with Physical Storage and shipment of documents to Sponsor/RM Hubs in accordance with study instructions and within required timelines to be followed.May serve as primary contact External clients.May train team members on records management tasks, policies, and procedures.May Function as team leader for records management projects.May lead teams functionally, where assigned, including awareness of scope of work, budget, and resources.May manage a team of records management or technically related staff working in support of projects within a designated office, Country or region.

I was dispensing prescription drugs, over-the-counter drugs, medical devices and additional pharmacy assortment in accordance with applicable legislation. I provided expert information on medicines, medical devices, dietetic foods and pharmacy supplements.I provided professional advice to patients on adhering to the right treatment regimen and on disease prevention, also consultations on diabetes, high blood pressure and active measurement of glucose and cholesterol levels, including interpretation of measured values.

My main duty during this three-month internship was drug dispensing activity including patient counselling. I was providing the patients with the information they need to know about their medications, side effects and interactions with other drugs. I was also preparing IPDs for specific patients following the instructions of the current European Pharmacopoeia.

Within the framework of Erasmus+ program I had the opportunity to get acquainted with the basic duties in a Hungarian pharmacy. The pharmacy I was working in is located in the heart of Budapest and cooperates with several university clinics, has a separate laboratory floor which allowed me to master the preparation of wide variety of individually prepared drugs including but not limited to sterile dosage forms, tablets, capsules, ointments, solutions and syrups. I was also performing other duties as a pharmacist intern, such as patient counselling and dispensing medicines and OTC products. In this role I learned a lot about teamwork and time management and I have mastered the proper soft-skills needed for performing the duties of a community pharmacist.