Senior CRA
Premier Research
Milan, Milan
1 gg fa

Description

Position at Premier Research Group Limited

Premier Research helps highly innovative bio-pharmaceutical and medical device companies transform life-changing ideas into reality.

We take on the most challenging areas of study, with a special focus on unmet needs in such areas as analgesia, CNS, rare diseases, medical device and diagnostics, and pediatric research.

We’re looking for a talented and energetic Senior CRA, in Italy to join our team!

Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact.

You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.

Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!

Imagine. Inspire. Innovate. Impact. With Us

You’ll be accountable for :

  • Delivering high-quality, timely monitoring reports for sponsor approval per Clinical Monitoring Plan timelines.
  • Scheduling site visits for monitoring as required by protocol monitoring visit windows.
  • Ensuring the validity, correctness, and completeness of clinical data reviewed and collected at assigned sites as dictated by trial protocol, ICH-
  • GCP / ISO 141155, and customer requirements.

  • Monitoring data remotely, on site, and via other approved modes with a focus on data integrity and patient safety, in accordance with specific country regulations.
  • Preparing for and conducting qualification, study initiation, interim monitoring, and close-out visits at investigator sites.
  • Managing query resolution with study sites and Premier Research data management operations.
  • Maintaining the project tracking system of subjects and site information.
  • Participating in Investigators’ Meetings as assigned by Project Managers.
  • Ensuring adherence to study timelines and budgets.
  • Identifying and escalating potential risks and identifying retraining opportunities for site study teams.
  • Mentoring junior-level staff and sharing knowledge and best practices.
  • Participating in training offered to increase therapeutic knowledge and keeping current with regulations and FDA guidance.
  • In specific countries or situations, assuming country-specific responsibilities and / or being named a subject-matter expert in one or more areas;
  • e.g. : start-up, regulatory, site contracts, office management.

  • Assuming additional duties on certain projects, such as clinical management for smaller or less complex studies.
  • You'll need this to be considered :

  • Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution;
  • a licensed health-care professional (i.e., registered nurse); or equivalent work experience required.

  • Prior experience in monitoring of pharma trials
  • Working knowledge of FDA Guidance Documents / EU Directives / local regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
  • Ability to multitask and work effectively in a fast-paced environment with changing priorities
  • Strong verbal and written communication skills
  • Fluency in written and verbal English is mandatory.
  • Any other language is a bonus
  • Excellent organizational and time-management skills, able to meet deadlines
  • Self-starter with lots of common sense and able to act on own initiative
  • Accountable, dependable and strong commitment
  • Applies clear and consistent performance standards and handles problems decisively and objectively
  • Customer service focused in approach to work, both internally and externally
  • Maintains a positive, results orientated work environment
  • Travel : 70-85%
  • You must be eligible to live and work in the specified country
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