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Clinical Research Associate - FSP

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Thermo Fisher Scientific

28d ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Milan, +3
    Remote

AI generated summary

  • You must have a science degree, CRA qualification, 1 year of monitoring experience, knowledge of ICH-GCP/EU/FDA, fluency in English and Italian, and a valid driver's license.
  • You will monitor sites, ensure data accuracy, document findings, resolve issues, support trial initiation and closeout, and contribute to project improvements and team communications.

Requirements

  • University degree in a science related field
  • CRA Qualified as per the Ministerial Decree dated 15/11/2011 and at least 1 year of independent monitoring experience in clinical development phases II-IV
  • Understanding of ICH-GCP, EU and FDA requirements
  • Fluency in English and in Italian
  • Valid Driver's License

Responsibilities

  • Monitors investigator sites with a risk-based monitoring approach: applies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.
  • Ensures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.
  • Assess investigational product through physical inventory and records review.
  • Documents observations in reports and letters according to timelines using approved business writing standards.
  • Escalates observed deficiencies and issues to clinical management expeditiously and follows all issues through to resolution. May need to maintain regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.
  • Participates in the investigator payment process. Ensures a shared responsibility with other project team members on issues/findings resolution. Investigates and follows-up on findings as applicable.
  • Participates in investigator meetings as necessary. Identifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.
  • Initiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted. Performs trial close out and retrieval of trial materials.
  • Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews as per project specifications.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System).
  • Contributes to the project team by assisting in preparation of project publications/tools and sharing ideas/suggestions with team members.
  • Contributes to other project work and initiatives for process improvement, as required.

FAQs

What is the work schedule for the Clinical Research Associate position?

The work schedule is standard, from Monday to Friday.

Where is the role based?

The role can be performed remotely for Clinical Research Associates based close to clinical hubs in Milan, Bologna, Florence, Rome, and Naples, with national travel requirements across Italy.

What type of monitoring approach does this position utilize?

The Clinical Research Associate monitors investigator sites using a risk-based monitoring approach.

What is the educational requirement for this position?

A university degree in a science-related field is required for this position.

What experience is needed to qualify for this role?

Candidates must be CRA qualified per the Ministerial Decree dated 15/11/2011 and possess at least 1 year of independent monitoring experience in clinical development phases II-IV.

What are the language requirements for this position?

Fluency in English and Italian is required.

What key skills are needed for the Clinical Research Associate role?

Key skills include proven clinical monitoring skills, critical thinking, effective communication, attention to detail, risk-based monitoring concepts, and good organizational skills.

Are there opportunities for career growth within the company?

Yes, PPD provides resources to help employees achieve individual career goals while contributing to research, development, and delivery of life-changing therapies.

What benefits does the company offer?

The company offers a competitive salary, an extensive benefits package centered around health and well-being, and a flexible working culture that values work-life balance.

How does PPD prioritize its values in the workplace?

PPD emphasizes its 4i values: Integrity, Innovation, Intensity, and Involvement, seeking to accelerate the delivery of safe and effective therapeutics for urgent health needs.

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Thermo Fisher Scientific

The World Leader In Serving Science

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.