Research Assignment: In vitro efficacy study of a new plasma-derived Factor V concentrate in patients with congenital Factor V deficiency (parahemophilia)

characterization of a plasma-derived FV concentrate for the treatment of congenital FV deficiency, to be carried out at the Department of Medicine – DIMED, primarily at the Coagulation Laboratory, via Ospedale Civile 105 and/or remotely under the supervision of Prof. Elena Campello, acting as Tutor/Scientific Supervisor.

The Research Assignment, with a duration of 12 months and an annual gross amount, for the recipient, of Euro 24.320,45 is announced in accordance with the current Regulations for the awarding of Research Assignments pursuant to Art. 22-ter of Law 240/2010 within the aforementioned research project, Scientific Disciplinary Group 06/MEDS-05 - INTERNAL MEDICINE, Scientific Disciplinary Sector MEDS-05/A - INTERNAL MEDICINE.

The Research Assignment, funded by the Department of Medicine - DIMED through the following projects: FLAMES project (inFLammation in the pAthogenesis of coMplEx diSeases) - Departments of Excellence 2023-2027, CUP code: C93C22009280001 - UGOV code: FLAMES_ECCELLENZA23_0; Kedrion spa Contract - Research and consulting activity related to the characterization of a plasma-derived FV concentrate for the treatment of congenital FV deficiency, CUP code: C93C26001130007 - UGOV code: SIMI_COMM26_01, has as its object the carrying out of the research activity specified below:

• Support in the planning, initiation, and conduct of clinical studies in accordance with Good Clinical Practice (GCP).
• Management of relations with the Ethics Committee and the Clinical Research Unit, including:
  • preparation and submission of regulatory documentation;
  • support in responding to requests for clarification and in managing substantial and non-substantial amendments;
  • management of communications concerning approvals, renewals, safety notifications, and study closure.
• Clinical data management and oversight, including:
  • design and review of paper and electronic Case Report Forms (CRFs);
  • data entry, validation, quality control, and cleaning;
  • query management and discrepancy resolution.
• Monitoring of clinical study progress, ensuring compliance with protocols, timelines, and established procedures.
• Collaboration with the Principal Investigator, Study Coordinator, Monitor, and Sponsor to ensure the accuracy and completeness of the data collected.
• Management of study documentation, including the Trial Master File and Investigator Site File, and support during audits and inspections.
• Support in preparing periodic reports on trial progress.
• Verification of compliance with applicable personal data protection regulations (GDPR).
• Support with clinical study close-out and final archiving.

Admission requirements

Young scholars who hold of a master's degree or single-cycle master's degree in in Biology, Biotechnology, Medical Biotechnology, Pharmacy, Pharmaceutical Chemistry and Technology, Medicine and Surgery and Statistics or related disciplines (the degree classes are specified in the Italian language section of the call) obtained no more than six years ago and have a curriculum suitable for assisting in the performance of research activities are eligible to participate in the selection process.

The following skills and experience, deemed necessary, are also required:

• Good knowledge of English, particularly scientific terminology and clinical trial documentation.
• Knowledge of national and international clinical trial regulations, including GCP, EU Regulation No. 536/2014, AIFA regulations, and the GDPR.
• Proven professional experience as a Data Manager, Clinical Trial Assistant (CTA), Clinical Research Coordinator (CRC), or in a similar role involving commercial and/or non-commercial clinical trials.
• Documented experience using Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS).
• Knowledge of clinical databases, data-cleaning tools, and data quality-assurance procedures.
• Ability to work in multidisciplinary teams and liaise with sponsors, CROs, monitors, and regulatory authorities.
• Accuracy, operational autonomy, and strong attention to protocol standardization.

The qualifications must be held on the announcement deadline date.

If the degree diploma was obtained abroad, it must be declared equivalent, for selection purposes only, to the master's degree or single-cycle master's degree by the Selection Committee.

Research Assignments, pursuant to Art. 22-ter of Law no. 240 of 30 December 2010, may not be awarded to those who are in one or more of the following situations:

• those who have held contracts referred to in Article 24 of Law 240/2010;
• permanent staff, employed on a permanent basis, of universities, public research bodies and institutions whose scientific specialization diploma has been recognized as equivalent to the PhD pursuant to Article 74, fourth paragraph, of Presidential Decree no. 382 of 11 July 1980;
• those who have a degree of kinship or affinity, up to and including the fourth degree, with a professor or researcher belonging to the Department proposing the selection or with the Rector, the Director General or a member of the University's Board of Directors;
• have already benefited from Research Assignments referred to in Art. 22-ter of Law 240/2010 as amended by Law no. 79/2022 for a period which, added to the duration of the assignment provided for in the announcement, exceeds a total of 3 years, even if not continuous. For the purposes of the duration of the aforementioned relationships, periods spent on maternity or paternity leave or for health reasons according to current legislation are not relevant.

The total duration of relationships established with holders of positions referred to in Articles 22 - (Research Contracts), 22-bis (Post-doc Assignments), 22-ter (Research Assignments) and contracts referred to in Article 24 (RTT) of Law 240/2010, even with different universities, state, non-state or online, with institutions of higher artistic, musical and dance education, with institutions whose scientific specialization diploma has been recognized as equivalent to the PhD pursuant to Article 74, fourth paragraph, of Presidential Decree no. 382 of 11 July 1980, and with public research bodies may not in any case exceed 11 years, even if not continuous. For the purposes of the duration of the aforementioned relationships, periods spent on maternity or paternity leave or for health reasons according to current legislation are not relevant.

Candidates are admitted to the selection with reserve.

The Structure that issued the announcement may order at any time, by reasoned decree of the Director, the exclusion from the selection for lack of the required requisites.

Where to apply

Website: https://pica.cineca.it/unipd/

Requirements

Research Field: Medical sciences » Medicine

Education Level: Master Degree or equivalent

Additional Information

Work Location(s)

Number of offers available: 1

Company/Institute: University of Padua

Country: Italy

State/Province: Italy

City: Padua

Postal Code: 35128

Contact

State/Province: Padova

City: Padova

Website: https://www.medicinadimed.unipd.it/

Street: via Giustiniani, 2

Postal Code: 35128