Clinical Research Associate II

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

📋 Description

• Propel AbbVie's clinical development pipeline by pursuing excellence in clinical research and converting scientific advancements into effective treatments.

• Act as the main point of contact for investigative sites.

• Offer contextual insights regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Perform site evaluations, training, routine monitoring, and closure oversight in accordance with protocols, regulations, GCP, ICH Guidelines, SOPs, and quality standards.

• Tailor site engagement strategies for designated studies.

• Collect local and site-specific insights and utilize CRM tools to monitor progress and assess impact.

• Link study protocols, scientific principles, and clinical trial necessities to daily operations.

• Assess and ensure recruitment and retention strategies based on the patient's disease journey.

• Cultivate knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys to facilitate recruitment and adherence to protocols.

• Mentor and train less experienced Clinical Research Associates (CRAs) and contribute to their professional development.

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments alongside the Central Monitoring team to detect issues related to study performance or patient safety.

• Address site risk indicators and implement preventive and corrective action strategies.

• Identify, assess, and propose investigators and sites for upcoming clinical studies.

• Ensure the quality and timely submission of site data, safety-event reports, and follow-ups.

• Maintain readiness for audits and regulatory inspections at assigned clinical sites.

• Manage investigator payments in accordance with executed contract obligations, where applicable.

⛳️ Requirements

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

• A minimum of 1 year of experience related to clinical practice is required.

• At least 6 months of experience monitoring clinical research for investigational drugs or devices is necessary.

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

• Preferred knowledge of relevant therapeutic area indications.

• Ability to comprehend and apply scientific concepts to the management of clinical trials.

• Advanced understanding of local regulatory and legal frameworks, ICH/GCP Guidelines, and relevant policies.

• Strong ability to collaborate across functions with both internal and external stakeholders.

• Excellent planning and organizational skills; capable of functioning effectively in a fast-paced environment with competing priorities and deadlines.

• Proficient in utilizing technology, tools, and resources.

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

• Capacity to build and leverage relationships with site personnel and create trusted partnerships through engagement, motivation, and training.

• Ability to apply functional expertise with guidance, engage critical thinking, and exercise sound judgment to resolve clinical site challenges.

• Uphold integrity in alignment with AbbVie’s code of business conduct and leadership principles.

• Self-driven and focused on achieving timely, quality outcomes in a dynamic environment.

🏝️ Benefits

• Employees have the option to work remotely.

• We are an equal opportunity employer.

• Dedicated to operating with integrity, fostering innovation, transforming lives, and serving the community.