Clinical Research Associate II

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

📋 Description

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

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

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

• Carry out site evaluations, training sessions, routine monitoring, and site closure activities.

• Ensure adherence to protocols, monitoring plans, relevant regulations, Good Clinical Practices (GCPs), ICH guidelines, Standard Operating Procedures (SOPs), and quality standards.

• Formulate and tailor site engagement strategies for assigned studies.

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

• Facilitate clinical trial execution by linking protocols, scientific principles, and trial requirements to daily activities.

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

• Develop knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to aid recruitment and protocol compliance.

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

• Engage in global or local task forces and initiatives.

• Perform ongoing risk assessments with the Central Monitoring team to identify issues related to study performance and patient safety.

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

• Identify, assess, and recommend investigators and sites.

• Ensure timely and accurate submission of site data and appropriate reporting and follow-up of safety events.

• Maintain readiness for audits and regulatory inspections.

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

⛳️ Requirements

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

• At least 1 year of experience in clinically related roles.

• Minimum of 6 months of clinical research monitoring experience for investigational drug or device trials.

• Understanding of risk-based monitoring strategies, including both onsite and offsite monitoring.

• Familiarity with applicable therapeutic area indications is preferred.

• Advanced knowledge of local regulatory and legal requirements, ICH/GCP guidelines, and relevant policies.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

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

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

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

• Ability to build and utilize site relationships and trusted partnerships.

• Skill in applying critical thinking and sound judgment to resolve clinical site issues.

• Integrity consistent with AbbVie's code of business conduct and leadership values.

• Self-motivated with a focus on timely, quality outcomes.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan.

• Eligibility for short-term incentive programs.