Clinical Research Associate I- US Territory- Remote

About the Role

Advance AbbVie's pipeline by striving for excellence in clinical research, turning science into medicine for our patients, and leveraging new advanced capabilities to drive industry-leading performance. This role focuses on meaningful and effective engagements with investigators and site staff, positioning AbbVie as the choice in clinical trials. It ensures appropriate conduct of trials, improves data integrity, compliance, overall study performance, and customer experience.

Responsibilities

• Serve as the primary point of contact for investigative sites, providing contextual information on clinical trials, connecting stakeholders, and strengthening AbbVie's positioning.
• Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient treatment principles to ensure a trusted partnership.
• Conduct site evaluation, training, routine monitoring, and site closure activities under supervision, ensuring compliance with protocols, monitoring plans, regulations, GCPs, ICH Guidelines, and AbbVie SOPs.
• Customize site engagement strategies, gather local insights, and utilize tools like CRM to track progress and measure impact.
• Evaluate and ensure effective recruitment and retention techniques based on the patient disease journey.
• Develop knowledge of therapeutic areas, assets, and clinical landscapes to support patient recruitment and protocol compliance.
• Perform continuous risk assessments and collaborate with the Central Monitoring team to address study performance and patient safety issues.
• Implement preventative and corrective action plans to mitigate risks and promote compliance.
• Identify, evaluate, and recommend new investigators/sites under supervision.
• Ensure quality and timely submission of data, including safety event reporting, and maintain audit and regulatory inspection readiness.
• Manage investigator payments as per contract obligations.

Qualifications

• Tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) preferred or equivalent experience.
• Clinically related experience, preferably in clinical research coordinating or data management.
• Knowledge of therapeutic area indications and ability to apply scientific concepts to clinical trials.
• Understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.
• Collaborative and cross-functional teamwork skills with strong planning and organizational abilities.
• Ability to leverage technology and tools for customer-centric support.
• Strong interpersonal, written, verbal, and presentation skills to build site relationships and partnerships.
• Integrity and alignment with AbbVie's code of conduct and leadership values.
• Self-motivated with a focus on delivering timely and quality outcomes in a fast-paced environment.

Additional Information

Candidates from the Southwest, Southeast, and Northeast regions near a major airport are strongly preferred. The role is eligible for short-term incentive programs and offers a comprehensive benefits package, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees.