Clinical Research Associate I

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

📋 Description

• Propel AbbVie’s clinical research initiatives by facilitating excellence in clinical research.

• Act as the main liaison for investigative sites.

• Provide contextual details regarding clinical trials and connect stakeholders with investigative sites.

• Align, train, and inspire site personnel and principal investigators on trial objectives, protocols, and patient treatment methodologies.

• Perform site evaluations, training, routine monitoring, and site closure tasks under supervision.

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

• Customize site engagement strategies for assigned studies with guidance.

• Collect local and site insights and utilize CRM tools to report, track, and assess strategy progress.

• Implement clinical trial protocols, scientific principles, and trial requirements in daily operations.

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

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

• Conduct ongoing risk assessments with the Central Monitoring team.

• Oversee site activities to pinpoint study performance and patient safety concerns.

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

• Identify, evaluate, and recommend investigators and sites under supervision.

• Guarantee the quality and prompt submission of site data and safety-event reports.

• Maintain audit and regulatory inspection readiness at assigned sites.

• Handle investigator payments in accordance with executed contracts, as applicable.

⛳️ Requirements

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

• Experience in clinical settings, ideally in clinical research coordination or data management.

• Familiarity with relevant therapeutic area indications is preferred.

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

• Capability to work collaboratively and across different functions.

• Strong planning and organizational skills.

• Ability to operate effectively and efficiently in a fast-paced environment with competing projects and deadlines.

• Proficiency in utilizing technology, tools, and resources.

• Critical thinking and sound judgment skills for addressing clinical site challenges.

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

• Skill in establishing and leveraging site relationships and trusted partnerships.

• Integrity aligned with AbbVie’s code of business conduct and leadership values.

• Self-driven and focused on achieving timely, quality results.

• Willingness to travel 75% of the time.

• Candidates located in the Southwest, Southeast, and Northeast regions, and near a major airport, are strongly preferred.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) retirement plan.

• Short-term incentive programs.

• Option for remote work arrangement.

• Travel compensation/eligibility associated with the role.