Clinical Research Associate II

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

📋 Description

• Propel AbbVie's clinical development pipeline through exceptional clinical research.

• Collaborate with investigators and site personnel to facilitate effective clinical trial interactions.

• Act as the main contact for investigative sites.

• Provide relevant information regarding clinical trials and connect stakeholders with investigative sites.

• Align, train, and inspire site personnel and principal investigators on trial objectives, protocols, and patient treatment principles.

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

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

• Develop and tailor site engagement strategies for designated studies.

• Collect local and site insights and utilize CRM tools to track progress and assess impact.

• Integrate study protocols, scientific principles, and clinical trial requirements into daily trial operations.

• Assess and ensure effective patient recruitment and retention strategies.

• Acquire knowledge of therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and train less experienced CRAs, contributing to their professional growth.

• Participate in global or local task forces and initiatives.

• Perform ongoing risk assessments with the Central Monitoring team to identify study performance or patient safety concerns.

• Address site risk signals and implement preventative and corrective action plans.

• Identify, evaluate, and recommend new investigators and sites.

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

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

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

⛳️ Requirements

• A minimum of 1 year of clinically related experience.

• At least 6 months of experience in clinical research monitoring of investigational drug or device trials.

• Preferred appropriate tertiary qualification in health-related fields (Medical, Scientific, Nursing).

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

• Preferred knowledge of relevant therapeutic area indications.

• 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 utilizing 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.

• Ability to apply functional expertise, critical thinking, and sound judgment to clinical site challenges.

• Act with integrity in line with AbbVie’s code of business conduct and leadership values.

• Self-motivated and focused on delivering timely, high-quality results in a fast-paced environment.

🏝️ Benefits

• Employees have the flexibility to work remotely.

• We are an equal opportunity employer.

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