Clinical Research Associate II – Immunology

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

📋 Description

• Advance AbbVie’s clinical research pipeline and transform scientific discoveries into medicine for patients.

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

• Provide context on clinical trials and connect stakeholders with investigative sites.

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

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

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

• Develop and tailor site engagement strategies.

• Collect insights from sites and utilize CRM tools to track progress and assess impact.

• Support the execution of clinical trials and ensure protocol compliance.

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

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

• Mentor and provide training to less experienced CRAs.

• Engage in global or local task forces and initiatives.

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

• Monitor clinical sites for study performance and patient safety concerns.

• Implement preventive and corrective action plans to reduce risks and enhance compliance.

• Identify, assess, and recommend investigators and sites.

• Ensure timely and accurate data submissions along with safety event reporting.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as stipulated by executed contracts.

⛳️ Requirements

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

• At least 1 year of clinically relevant experience.

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

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

• Preferred knowledge of relevant therapeutic area indications.

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

• Excellent cross-functional collaboration skills.

• Strong planning and organizational abilities.

• Capacity to work effectively in a fast-paced, dynamic environment with competing projects and deadlines.

• Ability to utilize technology, tools, and resources for customer-focused support.

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

• Capability to establish and utilize site relationships and trusted partnerships through engagement, motivation, and training.

• Critical thinking and sound judgment in addressing clinical site issues.

• Commitment to act with integrity in line with AbbVie’s code of business conduct and leadership ideals.

• Self-driven approach focused on achieving timely, quality outcomes in a high-pressure environment.

• Willingness and ability to travel 75% of the time.

🏝️ Benefits

• Paid time off, including vacation, holidays, and sick leave.

• Comprehensive medical, dental, and vision insurance.

• Participation in a 401(k) plan.

• Eligibility for short-term incentive programs.

• Opportunities for travel (role requires travel 75% of the time).