Clinical Research Associate II

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

📋 Description

• Propel AbbVie's pipeline by pursuing excellence in clinical research, transforming scientific advancements into effective treatments for our patients, and utilizing cutting-edge capabilities to achieve industry-leading performance.

• Collaborates with investigators and site personnel for impactful and efficient interactions that position AbbVie as the preferred choice for clinical trials.

• Emphasizes site clinical research to ensure the trial is conducted properly while enhancing data integrity, compliance, overall study performance, and the customer experience.

• Serves as the main point of contact for the investigative site.

• Demonstrates a high level of expertise in providing contextual information about clinical trials, connecting stakeholders to investigative sites, and reinforcing AbbVie’s positioning.

• Aligns, trains, and inspires site staff and principal investigators on the objectives of the clinical trial program, protocol, and patient treatment principles, fostering a trusted partnership.

• Conducts site evaluations, training, routine monitoring, and closure activities, ensuring compliance with protocols and monitoring plans, as well as applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, thereby ensuring the safety and protection of study subjects.

• Possesses an advanced understanding of site engagement and the ability to tailor site engagement strategies for assigned study(ies).

• Collects local/site insights and employs site engagement tools such as the Customer Relationship Management (CRM) tool to report and track progress and assess the impact of that strategy.

• Exhibits an advanced level of competency connecting the study protocol, scientific principles, and clinical trial requirements to the daily execution of clinical trial activities.

• Assesses and ensures the effectiveness of recruitment and retention strategies based on the patient disease journey.

• Develops a strong knowledge base of the therapeutic area, assets, and clinical landscape/patient journey to facilitate successful patient recruitment and overall protocol adherence.

• Holds an experienced level of competency to mentor and train less experienced Clinical Research Associates (CRAs) on various aspects of their work and provides feedback for their development.

• May engage in global/local task forces and initiatives.

• Responsible for tasks as assigned by the manager.

• Conducts continuous risk assessments proactively and collaborates with the Central Monitoring team to oversee activities performed by clinical sites in order to identify early signs of overall study performance or patient safety issues.

• Demonstrates advanced critical thinking abilities to address site risk signals while possessing a thorough understanding of site processes to facilitate study execution.

• Ensures preventive and corrective action plans are implemented as necessary to mitigate risks and encourage compliance with a customer-centric approach.

• Continuously identifies, evaluates, and recommends new or potential investigators/sites.

• Guarantees the quality of data submitted from study sites and ensures timely data submission, including appropriate reporting and follow-up for all safety events reported by site personnel.

• Maintains audit and regulatory inspection readiness at assigned clinical sites at all times.

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

⛳️ Requirements

• Relevant tertiary qualification in health-related disciplines (Medical, Scientific, Nursing) is preferred.

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

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

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

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

• Exhibits strong cross-functional collaboration abilities among internal and external stakeholders.

• Demonstrates excellent planning and organizational skills, with the capability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.

• Advanced proficiency in leveraging technology, tools, and resources to provide customer-centric support based on site health.

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

• Capable of applying functional expertise with appropriate guidance, using critical thinking skills and sound judgment to address clinical site challenges.

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

• A self-motivated individual focused on delivering timely and high-quality outcomes 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

• Participation in short-term incentive programs