Role Overview
Advance AbbVie's clinical development pipeline by supporting high-quality clinical research and translating scientific knowledge into medicines for patients. The Clinical Research Associate 2 partners closely with investigators and site staff, serving as a key point of contact for assigned investigative sites. The role focuses on appropriate clinical-trial conduct, data integrity, regulatory compliance, study performance, patient safety and positive site/customer experience. The position is full-time and remote, with travel required throughout Czechia and occasionally Slovakia.
Core Responsibilities
Serve as the primary point of contact for investigative sites and provide contextual information about clinical trials.
Connect relevant stakeholders with investigative sites and strengthen AbbVie's position as a clinical-trial partner.
Align, train and motivate site staff and principal investigators on clinical-trial objectives, protocols and patient-treatment principles.
Build trusted partnerships with investigators and site teams.
Conduct site evaluation, site initiation/training, routine monitoring and site closure activities.
Perform monitoring in accordance with protocols, monitoring plans, applicable regulations, Good Clinical Practice requirements, ICH Guidelines, AbbVie SOPs and quality standards.
Ensure protection and safety of study subjects throughout trial execution.
Site Engagement & Study Execution
Develop and customize site-engagement strategies for assigned studies.
Gather local and site-level insights and use engagement tools, including CRM systems, to track progress and measure impact.
Connect clinical-trial protocols, scientific principles and trial requirements to practical day-to-day site execution.
Evaluate and support effective patient recruitment and retention strategies based on the patient disease journey.
Develop therapeutic-area, clinical-asset, clinical-landscape and patient-journey knowledge to support recruitment and protocol compliance.
Monitoring, Risk Management & Compliance
Conduct proactive and continuous risk assessment of clinical-site activities.
Collaborate with Central Monitoring teams to identify early signals involving study performance or patient safety.
Apply critical thinking to investigate and resolve site-risk signals.
Use understanding of site processes to drive appropriate study execution.
Ensure preventive and corrective action plans are implemented when required to mitigate risks and promote compliance.
Maintain a customer-centric approach while addressing site issues.
Ensure clinical sites remain audit-ready and prepared for regulatory inspections at all times.
Investigator & Site Management
Identify, evaluate and recommend potential investigators and clinical sites on an ongoing basis.
Source potential sites through professional networking and internal AbbVie requests.
Support placement of planned clinical studies with appropriately qualified investigators.
Maintain effective relationships with investigators and site personnel.
Ensure site personnel submit required clinical data accurately and on time.
Ensure appropriate reporting and follow-up of safety events by site personnel.
Manage investigator payments in accordance with executed contractual obligations when applicable.
Training, Mentoring & Collaboration
Mentor and train less-experienced CRAs on relevant aspects of clinical research work.
Provide input into the development of junior CRA colleagues.
Participate in global or local task forces and initiatives when assigned.
Work effectively with internal and external stakeholders across functions.
Support activities and priorities assigned by management.
Regulatory & Technical Standards
Apply Good Clinical Practice (GCP) requirements and ICH Guidelines.
Follow applicable local regulatory and legal requirements.
Comply with AbbVie Standard Operating Procedures and quality standards.
Apply risk-based monitoring principles across onsite and offsite monitoring activities.
Maintain appropriate clinical-trial documentation, data quality and inspection readiness.
Understand scientific concepts and apply them to clinical-trial conduct.
Qualifications & Experience
Appropriate tertiary qualification in a health-related discipline such as Medical, Scientific or Nursing is preferred.
Minimum of 1 year of clinically related experience.
At least 6 months of clinical research monitoring experience involving investigational drug or device trials is required.
Familiarity with risk-based monitoring, including onsite and offsite monitoring, is required.
Knowledge of relevant therapeutic-area indications is preferred.
Advanced knowledge of applicable local regulatory and legal requirements, ICH/GCP Guidelines and relevant policies is expected.
Professional Competencies
Strong cross-functional collaboration with internal and external stakeholders.
Strong planning and organizational skills.
Ability to prioritize and deliver effectively in a dynamic environment with competing projects and deadlines.
Ability to leverage technology, tools and resources to provide customer-centric support based on site health.
Strong interpersonal, written, verbal, active-listening and presentation skills.
Ability to establish and maintain trusted relationships with clinical sites through engagement, motivation and training.
Critical-thinking and sound-judgment skills for resolving clinical-site issues.
Integrity and adherence to AbbVie business-conduct standards and leadership values.
Self-motivation and focus on timely, high-quality outcomes in a fast-paced environment.
Travel & Work Pattern
Remote work-location type.
Requires travel within Czechia.
Occasional travel to Slovakia may also be required.
Company Context
AbbVie describes its mission as discovering and delivering innovative medicines and solutions for serious health conditions and future medical challenges. The company operates across therapeutic areas including immunology, oncology and neuroscience, as well as its Allergan Aesthetics portfolio. AbbVie states its commitment to innovation, integrity, transforming lives, serving the community and equal-opportunity employment.
Recruitment & Safety Information
AbbVie states that it will not request sensitive personal information such as bank-account details, Social Security numbers or payment during recruitment.
Candidates should independently verify communications claiming to originate from AbbVie and avoid responding to suspected fraudulent recruitment communications or opening suspicious attachments and links.