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Clinical Research Associate II

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AbbVie

10d ago

  • Job
    Full-time
    Junior Level
  • Research & Development
    Healthcare
  • Rome
  • Quick Apply

AI generated summary

  • You must have a health-related qualification, 1+ year clinical experience (Oncology preferred), knowledge of ICH/GCP, strong organizational skills, fluency in English and Italian, and travel availability.
  • You will monitor clinical sites, ensure protocol compliance, conduct site visits, train personnel, manage payments, and recommend potential investigators while ensuring data quality and safety.

Requirements

  • - Appropriate tertiary qualification, health related (e.g., Medical, Scientific) preferred.
  • - Minimum of 1 year of clinically-related experience. A previous experience in Oncology is a plus.
  • - Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
  • - Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
  • - Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines. Ability to work, understand and follow work processes within the assigned function.
  • - Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity. Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated. Ability to use functional expertise and exercise good judgment.
  • - Demonstrated business ethics and integrity.
  • - Fluency both in English and Italian.
  • - Availability to travel.

Responsibilities

  • Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), Monitoring Plans, and to quality standards in conducting clinical research.
  • Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
  • Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
  • Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
  • Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
  • Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
  • Manages investigator payments as per executed contract obligations. Negotiates investigator/ hospital agreements with stakeholders. Maintain and complete own expense reports as per local and applicable guidelines.
  • Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.

FAQs

What is the primary mission of AbbVie?

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow.

What qualifications are preferred for the Clinical Research Associate II position?

An appropriate tertiary qualification in a health-related field, such as Medical or Scientific, is preferred.

How much clinical experience is required for this role?

A minimum of 1 year of clinically-related experience is required, with previous experience in Oncology being a plus.

What languages must candidates be fluent in for this job?

Candidates must be fluent in both English and Italian.

What are some key responsibilities of the Clinical Research Associate II?

Key responsibilities include monitoring clinical investigative sites, conducting site visits, ensuring compliance with regulations, training site personnel, and managing investigator payments.

Is travel required for this position?

Yes, availability to travel is required for the role.

What does AbbVie emphasize in its hiring practices?

AbbVie emphasizes equal opportunity and a commitment to diversity and inclusion, ensuring that all applicants are considered without discrimination.

Are there specific protocols that the Clinical Research Associate II must adhere to?

Yes, the Clinical Research Associate II must adhere to local regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs).

Is experience in oncology a requirement for the Clinical Research Associate II position?

While experience in oncology is not a strict requirement, it is considered a plus.

How does AbbVie ensure data quality from study sites?

AbbVie ensures data quality by requiring compliance with study monitoring plans, timely data submission, and appropriate reporting and follow-up for safety events by site personnel.

AbbVie

Science & Healthcare
Industry
10,001+
Employees

Mission & Purpose

AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first — for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.