Clinical Research Associate Ii

AbbVie; Newport; On-site; GBP 35,000 - 50,000; Full time

Job summary

A leading global biopharmaceutical company is looking for a Clinical Research Associate in Newport, UK, to monitor clinical studies and ensure adherence to protocol and regulatory standards. You will conduct site visits, train personnel, and manage investigator agreements. The ideal candidate will have a tertiary qualification in health-related fields and extensive experience in Oncology, alongside strong analytical and organizational skills. Join us in making a significant impact on patients’ lives across key therapeutic areas.

Qualifications

• Extensive clinically-related experience in Oncology preferred.
• In-depth knowledge of regulations governing clinical research and ICH/GCP Guidelines.
• Strong planning and organizational skills in a dynamic environment.

Responsibilities

• Monitor activities conducted by clinical investigative sites for adherence.
• Conduct site qualification, initiation, interim monitoring, and study closeout visits.
• Train study site personnel on protocol and regulatory requirements.

Skills

Analytical skills

Organizational skills

Interpersonal skills

Communication skills

Education

Tertiary qualification in health-related field

Job description

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. Maintains and completes 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.

Qualifications and Requirements

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

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. We strive to have a remarkable impact on people's lives across several key therapeutic areas—immunology, oncology, neuroscience, and eye care—and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.Abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.