Clinical Research Associate II- Eye Care/Specialty/Aesthetics - Remote

About the Role

The role entails a high level of engagement with site staff and principal investigators, providing contextual information on clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie's positioning. You will align, train, and motivate site staff and principal investigators on the goals of the clinical trial program, protocol, and patient treatment principles, ensuring a trusted partnership.

What You Will Do

• Serve as the primary point of contact for the investigative site, providing high-level competency or experience in delivering contextual information on clinical trials.
• Connect stakeholders to the investigative sites and strengthen AbbVie’s positioning through effective communication and relationship-building.
• Conduct site evaluation, site training, routine, and site closure monitoring activities in compliance with the protocol, monitoring plans, applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards.
• Utilize advanced understanding of site engagement to customize site engagement strategies for assigned studies, gathering local/site insights and leveraging site engagement tools like the Customer Relationship Management (CRM) tool.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey, developing solid knowledge of the therapeutic area, asset, and clinical landscape/patient journey.
• Possess an experienced level of competency to mentor and train less experienced CRAs on various aspects of work, providing input into their development.
• Participate in global/local task forces and initiatives as required.
• Conduct continuous risk-assessment, proactively monitoring activities conducted by clinical sites to detect early overall study performance or patient safety issues in collaboration with the Central Monitoring team.
• Resolve site risk signals through critical thinking, having a robust understanding of site processes to drive study execution, and ensure preventative and corrective action plans are in place.
• Identify, evaluate, and recommend new/potential investigators/sites on an ongoing basis, potentially through networking or internal AbbVie requests.
• Ensure the quality of data submitted from study sites, assuring timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Maintain audit and regulatory inspection readiness at assigned clinical sites at all times.
• Manage investigator payments as per executed contract obligations, as applicable.

What We Are Looking For

• Appropriate tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred.
• Minimum of 1 year of clinically related experience, with at least 6 months required in clinical research monitoring of investigational drug or device trials.
• Familiarity with a risk-based monitoring approach, onsite and offsite monitoring.
• Knowledge of appropriate therapeutic area indications is preferred, with the ability to understand and apply scientific concepts.
• Advanced understanding of clinical trial requirements and the ability to connect study protocols, scientific principles, and clinical trial requirements to day-to-day clinical trial execution activities.
• Experience with Excel and other data management tools.
• Strong communication and interpersonal skills, with the ability to work independently and as part of a team.
• Ability to think critically and resolve problems effectively.

Nice to Have

• Experience in eye care, specialty, and aesthetics clinical trials.
• Knowledge of Good Clinical Practices (GCPs), ICH Guidelines, and regulatory requirements.
• Certification in clinical research, such as CCRA or ACRP.
• Experience with site engagement tools and Customer Relationship Management (CRM) software.
• Familiarity with clinical trial management systems and electronic data capture systems.

Benefits and Perks

• Competitive salary and benefits package.
• Opportunity to work with a leading pharmaceutical company.
• Remote work arrangement with flexible working hours.
• Professional development opportunities, including training and certification programs.
• Access to cutting-edge technologies and tools.
• Collaborative and dynamic work environment.
• Health insurance and retirement plans.
• Paid time off and holidays.

• Ensure your resume and cover letter are tailored to the clinical research industry, highlighting your experience with site engagement, data integrity, and compliance.
• Develop a strong understanding of the therapeutic area, including current treatments, ongoing research, and future directions.
• Practice your communication skills, as effective interaction with site staff, investigators, and other stakeholders is crucial for success in this role.
• Be prepared to discuss your experience with risk-based monitoring, onsite and offsite monitoring, and how you have applied these skills in previous roles.
• Consider obtaining certifications like CCRA or ACRP to demonstrate your expertise and commitment to the field.
• When negotiating salary, research the market average for similar positions and be prepared to discuss your expectations based on your experience and qualifications.
• Pay attention to the company culture and values during the interview process, as fit is crucial for long-term success in a remote role.