Clinical Research Associate II

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

📋 Description

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

• Offer contextual information regarding clinical trials and link stakeholders with investigative sites.

• Align, train, and inspire site staff and principal investigators about clinical 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, AbbVie SOPs, and quality standards.

• Tailor site engagement strategies for designated studies.

• Collect site insights and utilize CRM tools to report, track progress, and measure impact.

• Connect study protocols and scientific concepts with daily clinical trial execution.

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

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

• Mentor and train junior CRAs, providing developmental feedback.

• Engage in global/local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

• Identify, evaluate, and recommend investigators and sites for upcoming clinical studies.

• Ensure quality and timely submission of site data, safety event reporting, and follow-up.

• Maintain readiness for audits and regulatory inspections.

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

• Travel to clinical research sites within Southern California.

⛳️ Requirements

• Must reside in Southern California.

• Bachelor’s degree or an equivalent qualification; a health-related degree is preferred (e.g., Medical, Scientific, Nursing, Pharmacy).

• A minimum of 1 year of clinically related experience.

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

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

• Ability to comprehend and apply scientific concepts to clinical trial operations.

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

• Excellent cross-functional collaboration skills.

• Strong planning and organizational abilities.

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

• Proficiency in leveraging technology, tools, and resources for customer-focused site support.

• Exceptional interpersonal skills.

• Outstanding written, verbal, active listening, and presentation abilities.

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

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

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

• Self-motivated and focused on achieving timely, quality outcomes in a fast-paced environment.

• Willingness to travel for site visits.

🏝️ Benefits

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

• Medical insurance coverage.

• Dental insurance.

• Vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Equal opportunity employer.

• Reasonable accommodations for applicants from the US & Puerto Rico.