Clinical Research Associate II – Immunology

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

📋 Description

• Propel AbbVie’s clinical research initiatives by promoting excellence in clinical studies.

• Collaborate with investigators and site personnel to foster effective clinical trial partnerships.

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

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

• Align, educate, and inspire site staff and principal investigators on trial objectives, protocols, and patient care principles.

• Perform site evaluations, training sessions, routine monitoring, and final site closure assessments.

• Ensure adherence to protocols, monitoring plans, regulations, Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards.

• Create and tailor site engagement strategies.

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

• Support the execution of clinical trials and adherence to protocols.

• Assess recruitment and retention strategies based on the patient disease trajectory.

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

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

• Engage in both global and local task forces and initiatives.

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

• Identify and mitigate site risk signals while implementing preventative and corrective action plans.

• Evaluate and recommend investigators and clinical trial sites.

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as applicable.

⛳️ Requirements

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

• A minimum of 1 year of clinically related experience.

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

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

• Preferred knowledge of relevant therapeutic area indications.

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

• Strong collaborative skills across functions.

• Excellent planning and organizational abilities.

• Capacity to function effectively in a dynamic environment with multiple projects and deadlines.

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

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

• Ability to establish and maintain site relationships and trusted partnerships.

• Capacity to apply critical thinking and sound judgment to clinical site matters.

• Conducts oneself with integrity in alignment with AbbVie’s code of business conduct and leadership values.

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

• Willingness to travel up to 75% of the time.

🏝️ Benefits

• Paid time off (including vacation, holidays, and 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.