Vacancies

Vacancies 2021-07-27T11:35:46+00:00

New positions opened

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Clinical Research Associate (CRA) | Home-based or office-based at our Italian branches

Job Locations | Bari, Pavia, Rome (Italy)

Responsibilities

CVBF is looking for two experienced Clinical Research Associates to conduct oversight and monitoring activities for profit and no-profit clinical trials.

Expected starting date: As soon as possible.

The successful candidate will be working on both pharmacological and non-pharmacological studies.

Confident candidates with strong site management skills and the ability to work independently whilst establishing a high-trust environment with the Clinical Operations team and the clinical sites’ staff. He/she will constantly work as an integral part of the CVBF monitoring-service study team, remotely and with occasional meetings. The Clinical Research Associate will be responsible for the successful management of investigator sites throughout the entire trial process.

Key responsibilities include:

  • Planning and conducting various site visits (site qualification and initiation, monitoring at sites and remote, close-out) in accordance with the clinical monitoring plan
  • Developing effective collaboration with investigator site staff to achieve the planned key clinical metrics
  • Ensuring the proper storage and accountability of clinical supplies and following-up of drug safety issues
  • Ensuring integrity of clinical data by sufficiently maintaining site tracking records and working in compliance with relevant guidelines

Qualifications

Successful candidate will have:

  • University degree in a science related field or certified health care professional or equivalent experience
  • At least 2 years of prior experience conducting monitoring visits, including site management, from either a pharmaceutical company or a CRO/SMO environment
  • Experience in Oncology and Medical Devices
  • In-depth working knowledge of ICH-GCP guidelines as well as local and international regulatory requirements
  • Fluency in English and local language (spoken and written)

How to apply

Interested candidates are invited to submit their updated CV, together with the completed CRA assessment form, and a cover letter, specifying the job offer reference, the current position, salary, and notice period to [email protected]

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Send your Application

Regulatory Officer | Office-based with possibility of partial smart working

Job Locations | Pavia, Italy

Responsibilities

CVBF is looking for an experienced Regulatory Officer with strong relationship skills and the ability to work independently whilst establishing a high-trust environment with the CVBF Regulatory Team and its partners.

Successful candidate will be able to independently manage the ethical-regulatory processes required for conducting clinical studies (interventional, observational, on drug, ATMP or medical device).

Key responsibilities include:

  • Registration and update of the study in recognised international registries (e.g., clinicaltrial.gov, EudraCT)
  • Preparation of a master submission package and its adaptation to national/local requirements
  • Management of the study authorization process from submission to final approval
  • Negotiation of contract with site(s)
  • Preparation and management of substantial amendments
  • Notification of the end of the study

Expected starting date: September 2021.

Qualifications

Successful candidate will have:

  • University degree in a science related field or certified health care professional or equivalent experience
  • At least 3 years of prior experience conducting ethical-regulatory regulatory submissions
  • In-depth working knowledge of ICH-GCP guidelines as well as local and international regulatory requirements
  • Fluency in English and local language (written and spoken)

How to apply

Interested candidates are invited to send their updated CV, together with a cover letter, specifying the job offer reference, the current position, salary, and notice period to [email protected].

Send your Application
Send your Application
The CVBF – Consorzio per Valutazioni Biologiche e Farmacologiche - mission is to conduct research and educational activities in the pharmaceutical field integrating regulatory, epidemiological, economical and statistical expertise. CVBF is constantly looking for new project managers, study coordinators, CRAs, biostatisticians, and researchers in paediatrics and rare diseases fields. Feel free to send your own job application at [email protected]
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