Company Description
About 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. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
We are looking for a Clinical Research Associate (CRA) to join our Clinical Operations team in Amadora, Portugal, in a hybrid role. In this position, you will contribute to the successful delivery of AbbVie clinical studies by building strong partnerships with investigators and site staff, ensuring high-quality study conduct, and supporting the protection and safety of study participants.
You will work closely with clinical study teams and investigative sites across Phase I–IV studies, gaining exposure to a wide range of clinical research activities in a collaborative and patient-focused environment. This is an excellent opportunity for a motivated clinical research professional to develop their expertise while contributing to the advancement of innovative medicines.
Key Responsibilities
- Build trusted and effective partnerships with investigators and site staff by aligning them with study objectives, protocol requirements, patient treatment principles, and applicable regulatory expectations.
- Conduct site qualification, site initiation, routine on-site and remote monitoring, and study close-out visits for Phase I–IV clinical studies, in accordance with the protocol, monitoring plan, GCP, ICH guidelines, AbbVie SOPs, and applicable regulations.
- Train site personnel on the protocol, study procedures, safety reporting requirements, and relevant regulatory expectations, in collaboration with the clinical study team.
- Oversee site activities, proactively identify risks and compliance issues, and support the implementation and follow-up of corrective and preventive action plans in collaboration with Central Monitoring and relevant stakeholders.
- Ensure the quality and timely submission of data from investigative sites, including appropriate reporting and follow-up of safety events, while supporting the protection and safety of study participants.
- Support patient recruitment and retention activities by applying an understanding of the patient journey, therapeutic area, and local site realities.
- Identify, evaluate, and recommend potential investigators and investigative sites, using local knowledge, professional networks, and internal AbbVie resources as appropriate.
- Maintain site and study documentation in an inspection-ready state and support regulatory inspection readiness at assigned sites.
- Manage investigator payments in line with executed contractual obligations, support the negotiation of investigator and hospital agreements with relevant stakeholders, and complete expense reports in accordance with local requirements and applicable guidelines.
- Contribute to site engagement strategies by gathering local insights, tracking progress, reporting outcomes, and identifying opportunities for continuous improvement.
Qualifications
- Bachelor’s degree or equivalent qualification in a health-related or scientific discipline preferred, such as Medicine, Nursing, Pharmacy, Life Sciences, or a related field.
- Minimum of one year in clinical research monitoring.
- Strong planning, organizational, communication, and interpersonal skills, with the ability to manage multiple priorities and collaborate effectively with study teams, investigators, and site staff.
- Good analytical and problem-solving skills, with the ability to identify site issues, exercise sound judgment, and support appropriate corrective actions.
- Self-motivated and collaborative, with a strong commitment to quality, compliance, patient safety, ethical conduct, and timely delivery.
Additional Information
AbbVie Culture
At AbbVie, we care deeply about bringing innovative solutions to patients in need. By joining us as a CRA, you'll be at the forefront of our mission, working in a dynamic and supportive environment that encourages growth and collaboration.
- All4OneAbbVie: Foster strong interpersonal relationships and teamwork.
- Decide Smart & Sure: Navigate ambiguity and make informed decisions.
- Agile & Accountable: Communicate a clear and inspiring vision.
- Clear & Courageous: Provide honest and constructive feedback.
- Make Possibilities Real: Efficiently plan and execute tasks while adapting to challenges.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html