Clinical Research Associate 2

This is a fully remote position, open to applicants in Czechia.

📋 Description

• Enhance AbbVie's clinical research pipeline by promoting excellence in clinical research and converting scientific advancements into medical solutions.

• Act as the main liaison for investigative sites.

• Provide relevant information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, train, and inspire site staff and principal investigators on the objectives of clinical trials, protocols, and patient treatment principles.

• Conduct evaluations of sites, provide training, perform routine monitoring, and oversee site closure activities.

• Ensure adherence to protocols, monitoring plans, regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards.

• Develop and tailor site engagement strategies for assigned studies.

• Collect local insights and site feedback while utilizing CRM tools to monitor progress and assess the impact of strategies.

• Integrate study protocols, scientific principles, and trial requirements into everyday execution.

• Assess and ensure recruitment and retention strategies are aligned with the patient disease journey.

• Build knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to support recruitment and adherence to protocols.

• Mentor and guide less experienced CRAs, contributing to their professional development.

• Participate in global or local task forces and initiatives.

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team.

• Monitor activities at clinical sites to identify any issues related to study performance or patient safety.

• Address site-risk signals and implement preventive and corrective action plans.

• Identify, assess, and recommend potential investigators and sites.

• Ensure timely and quality submission of site data, including safety-event reporting and follow-up.

• Maintain readiness for audits and regulatory inspections at designated sites.

• Manage investigator payments in accordance with executed contractual obligations, as applicable.

• Travel within Czechia and occasionally to Slovakia.

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (Medical, Scientific, Nursing) is preferred.

• At least 1 year of clinically related experience.

• A minimum of 6 months of experience in monitoring clinical research for investigational drug or device trials.

• Familiarity with risk-based monitoring approaches, including onsite and offsite monitoring.

• Preferred knowledge of relevant therapeutic area indications.

• Ability to understand and apply scientific principles related to conducting clinical trials.

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capability to work effectively in a dynamic environment with competing projects and deadlines.

• Advanced proficiency in leveraging technology, tools, and resources.

• Strong interpersonal, written, verbal, active listening, and presentation skills.

• Ability to establish and cultivate site relationships and trusted partnerships through engagement, motivation, and training.

• Competence in applying critical thinking and sound judgment to address issues at clinical sites.

• Commitment to acting with integrity in accordance with AbbVie’s code of business conduct and leadership values.

• Self-motivated with a focus on delivering timely, high-quality outcomes in a fast-paced setting.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• We are committed to operating with integrity, fostering innovation, transforming lives, and serving the community.