Clinical Research Associate II

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

📋 Description

• Act as the main contact for investigative sites.

• Provide context for 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.

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

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

• Tailor site engagement strategies and monitor progress using CRM tools.

• Collect local and site insights to enhance engagement and study performance.

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

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

• Mentor and train junior CRAs and assist in their professional development.

• Participate in global or local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

• Identify, assess, and recommend investigators and clinical trial sites.

• Ensure timely and high-quality submission of site data and safety-event reporting.

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments in accordance with executed contracts, where applicable.

⛳️ Requirements

• At least 1 year of clinically related experience.

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

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

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

• Knowledge of relevant 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.

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

• Ability to utilize technology, tools, and resources for site support.

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

• Ability to build site relationships and trusted partnerships through engagement, motivation, and training.

• Critical thinking and judgment skills for resolving clinical-site issues.

• Integrity consistent with AbbVie’s business conduct code 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.

• Short-term incentive programs.

• Remote work options.

• Equal opportunity employer.

• Reasonable accommodations for applicants with disabilities.