Clinical Research Associate II

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

📋 Description

• Propel AbbVie’s clinical research initiatives and support the development of innovative medicines and solutions.

• Act as the main liaison for investigative sites.

• Offer clinical trial insights and link stakeholders with investigative sites.

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

• Perform site evaluations, training, routine monitoring, and site closure tasks.

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

• Tailor site engagement strategies and monitor their effectiveness and impact utilizing CRM tools.

• Relate study protocols and scientific concepts to everyday trial execution.

• Assess recruitment and retention methods based on the patient disease pathway.

• Cultivate knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and guide less experienced Clinical Research Associates (CRAs).

• Engage in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

• Identify and assess potential investigators and clinical sites.

• Ensure data integrity, prompt data submission, and thorough safety-event reporting and follow-up.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments as per contractual obligations.

⛳️ Requirements

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

• A minimum of 1 year of experience in a clinically related role.

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

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

• Knowledge of therapeutic area indications is preferred.

• 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 perform effectively in a dynamic environment with competing projects and deadlines.

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

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

• Ability to build and utilize site relationships and partnerships.

• Aptitude for applying critical thinking and sound judgment to clinical site challenges.

• Integrity in alignment with AbbVie’s business conduct code and leadership values.

• Self-driven and focused on achieving timely, high-quality outcomes.

🏝️ Benefits

• Paid time off (vacation, holidays, sick leave).

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Commitment to equal opportunity employment.

• Reasonable accommodations for applicants in the US and Puerto Rico.

• Commitment to veterans and disabled individuals in employment.