Clinical Research Associate II – Oncology

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

📋 Description

• Propel AbbVie's pipeline forward by pursuing excellence in clinical research.

• Collaborate with investigators and site personnel to ensure meaningful and effective interactions, establishing AbbVie as the preferred choice for clinical trials.

• Emphasize the conduct of site clinical research to ensure proper trial execution while enhancing data integrity, compliance, overall study performance, and customer experience.

• Act as the primary point of contact for the investigative site.

• Possess a high level of competency or experience in providing contextual information regarding clinical trials.

• Perform site evaluations, conduct training sessions, and oversee routine and closure monitoring activities in compliance with protocols and monitoring plans.

• Demonstrate an advanced understanding of site engagement and the ability to tailor site engagement strategies for assigned studies.

• Collect local/site insights and utilize site engagement tools like the Customer Relationship Management (CRM) tool.

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

• Exhibit a competent level of experience to mentor and train less experienced Clinical Research Associates (CRAs) on various work aspects and contribute to their development.

• Responsible for ongoing risk assessment and, in collaboration with the Central Monitoring team, monitor clinical site activities to identify early study performance or patient safety concerns.

• Ensure that preventative and corrective action plans are implemented as necessary to mitigate risks and promote compliance through a customer-centric approach.

• Continuously identify, evaluate, and recommend new or potential investigators/sites.

⛳️ Requirements

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

• At least 1 year of clinically related experience, including a minimum of 6 months in clinical research monitoring of investigational drug or device trials.

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

• Knowledge of relevant therapeutic area indications is preferred, along with the ability to understand and apply scientific concepts related to clinical trials.

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

• Strong ability to collaborate cross-functionally among internal and external stakeholders.

• Excellent planning and organizational skills, capable of working effectively and efficiently in a dynamic environment with competing projects and deadlines.

• Advanced capability to leverage technology, tools, and resources to provide customer-centric support based on site health.

• Strong interpersonal skills, including excellent written, verbal, active listening, and presentation abilities, with a talent for building and leveraging site relationships and trusted partnerships through engagement, motivation, and training.

• Ability to apply functional expertise with appropriate guidance, utilize critical thinking, and exercise good judgment in addressing clinical site issues.

• Act with integrity in alignment with AbbVie’s code of business conduct and leadership values.

• Self-driven individual committed to delivering timely and high-quality results in a fast-paced environment.

🏝️ Benefits

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

• Medical, dental, and vision insurance.

• 401(k) plan available to eligible employees.

• Eligibility to participate in short-term incentive programs.