Project Assistant - EMEA/APAC

Highly Competitive
  1. Contract
  2. Clinical Trial Assistant (CTA)
  3. Italy
Posting date: 15 Feb 2019

ProClinical is advertising a vacancy for a Project Assistant with a leading global contract research organisation (CRO) that provides comprehensive integrated, drug development, laboratory and lifecycle management services. This company, which prides itself on its innovative technologies and therapeutic expertise, is seeking for a talented individual to join their team in Italy on a contract basis. This position will run for six months.

The Project Assistant will provide technical support to the project team and will coordinate non-clinical responsibilities of project administration as applicable to the client contract under the direction of the assigned Clinical Manager or Sr. Clinical Manager.

Job Responsibilities:

  • Reviewing regulatory documents for proper content.
  • Performing company investigator file reviews and logging of outstanding issues in project related tracking tools.
  • Liaising with monitoring and investigative sites to resolve outstanding identified regulatory issues.
  • Disseminating study related information, including project tracking updates to Clients, clinical study teams, and other company departments.
  • Assisting with the identification of potential investigators and the development/distribution of initial protocol packets.
  • Creating meeting agendas and minutes.
  • Coordinating team conference calls and distributing meeting minutes.
  • Adhering to Good Clinical Practices, country specific regulations, company/client SOPs, and Working Practice Documents regulations for all non-clinical/clinical aspects of project implementation, execution, and closeout.

Skills and Requirements:

  • A University Degree or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities.
  • Demonstrable experience with Medi Data Rave.
  • A thorough knowledge of Good Clinical Practices, along with specific regulations from both internal and external regulators.
  • Excellent interpersonal skills, including communication, persuasion, and presentation.
  • Capable of completing the company's clinical training program (CAFT - Clinical Administration Foundation Training).
  • Excellent organisation skills and strong attention to detail, with a proven ability to handle multiple tasks efficiently and effectively.
  • Capable of effectively analysing project specific data/systems to ensure accuracy and efficiency.
  • A flexible mindset capable of reprioritising their workload to meet changing project timelines.
  • Fluency in English, and proficiency in Italian.
  • Excellent computer skills, with proficiency in MS Office Suite, and an ability to obtain knowledge and master all clinical trial database systems.
  • An ability to mentor and train new Project Assistants as needed.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call Kelechi Dyke on +44 203 854 0200 or upload your CV on our website -

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.