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Clinical Research Associate II

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AbbVie

18d ago

  • Job
    Full-time
    Junior Level
  • Science
    Healthcare
  • Madrid
  • Quick Apply

AI generated summary

  • You need a relevant degree, 2+ years in Oncology, knowledge of clinical trial regulations, strong organizational and communication skills, and demonstrated ethics and integrity.
  • You will monitor clinical sites, ensure compliance with protocols and regulations, conduct site visits, manage data quality, train site personnel, and negotiate investigator agreements.

Requirements

  • Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
  • Minimum of 2 year of clinically-related experience in Oncology.
  • 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.

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 federal regulations and 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 1-3 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 main role of a Clinical Research Associate II at AbbVie?

The main role of a Clinical Research Associate II at AbbVie involves monitoring clinical investigative sites to ensure compliance with study protocols, federal regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs).

Is prior experience in clinical research required for this position?

Yes, a minimum of 2 years of clinically-related experience in Oncology is required for this position.

What qualifications are preferred for this role?

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

Are there opportunities for training in this position?

Yes, the role involves training study site personnel on the protocol and applicable regulatory requirements in collaboration with relevant project team members.

What are the key skills needed for a Clinical Research Associate II?

Key skills include strong planning and organizational abilities, analytical and conceptual capabilities, interpersonal skills, and effective communication.

Will I be responsible for managing investigator payments?

Yes, the position involves managing investigator payments as per executed contract obligations and negotiating investigator/hospital agreements.

Is the Clinical Research Associate II position focused on any specific therapeutic area?

Yes, the position particularly requires in-depth knowledge and understanding of appropriate therapeutic indications related to Oncology.

Does AbbVie provide equal employment opportunities?

Yes, AbbVie is committed to equal opportunity employment and does not discriminate against any employee or applicant based on legally protected group status.

What does compliance with the study monitoring plan entail?

Compliance with the study monitoring plan entails ensuring the safety and protection of study subjects, adherence to regulations, and conducting regular monitoring visits as needed.

How can applicants seeking reasonable accommodations apply?

US & Puerto Rico applicants seeking reasonable accommodations can find more information and apply through the provided link on AbbVie’s website.

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.