AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter (https://twitter.com/abbvie) , Facebook (https://www.facebook.com/AbbVieGlobal) , Instagram (https://www.instagram.com/abbvie/?hl=en) , YouTube (https://www.youtube.com/user/AbbVie) and LinkedIn (https://www.linkedin.com/company/abbvie) .
Clinical Research Associate (CRA)
- Home based or in the modern office in Maidenhead.
- Team: working in a stimulating matrix environment reporting into the Clinical Operations Manager.
- Package: Competitive salary and comprehensive benefits package.
Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. This position functions in an off-site and affiliate based capacity.
The CRA conducts clinical site monitoring visits across a range of protocols and multiple therapeutic areas, ensuring AbbVie studies are conducted according to all applicable regulations and business processes. Ensures regulatory inspection readiness at assigned clinical sites.
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.
Conducts all clinical site monitoring activities according to the monitoring plan and in accordance with the study timelines and company objectives. This includes but is not limited to:
Manages and monitors the activities of clinical investigative sites across a range of protocols and multiple therapeutic areas.
Overviews the overall activities of site personnel over whom there is no direct authority and motivate/influence them to meet study objectives. Is proactive in managing the site and ensures action plans are put into place as needed to ensure compliance.
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.
Qualifications & Experience:
- Bachelor's Degree required; medical/science/nursing background is preferred.
- Proven, relevant clinically-related experience in clinical research monitoring.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Experience in on-site monitoring of investigational drug or device trials is required.
- Exhibits strong planning and organisational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Exhibits high degree of flexibility when facing changes in the work environment.
- Attention to detail and strong interpersonal skills.
Yes, 50 % of the Time
Job Level Code
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.Apply for this job