Clinical Research Associate II

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

📋 Description

• Covering the NJ/PA region

• Advance AbbVie's pipeline by aiming for excellence in clinical research, transforming scientific discoveries into medical solutions for our patients, and utilizing advanced capabilities to achieve industry-leading performance.

• Collaborates with investigators and site staff to ensure meaningful and effective interactions, positioning AbbVie as the preferred choice for clinical trials.

• Concentrates on site clinical research that guarantees proper trial conduct while enhancing data integrity, compliance, overall study performance, and the customer experience.

• Recognized as the primary contact for the investigative site.

• Demonstrates a high level of expertise or experience in providing contextual information about clinical trials, connecting stakeholders to investigative sites, and strengthening AbbVie’s market position.

• Aligns, trains, and motivates site staff and principal investigators regarding the objectives of the clinical trial program, protocol, and patient treatment principles, ensuring a trusted partnership.

• Executes site evaluations, training, routine monitoring, and site closure activities in compliance with the protocol and monitoring plans, conforming to applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring the safety and protection of study subjects.

• Possesses an advanced understanding of site engagement and the ability to tailor 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 strategies.

• Exhibits an advanced competency in linking study protocols, scientific principles, and clinical trial requirements to daily clinical trial execution activities.

• Assesses and ensures effective recruitment and retention techniques and plans based on the patient disease journey.

• Develops a solid understanding of the therapeutic area, asset, and clinical landscape/patient journey to facilitate successful patient recruitment and overall protocol compliance.

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

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

• Responsible for tasks assigned by the manager.

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

• Exhibits advanced critical thinking skills to resolve site risk signals while possessing a thorough understanding of site processes to drive study execution.

• Ensures that preventative and corrective action plans are established as necessary to mitigate risk and enhance compliance through a customer-centric approach.

• Identifies, evaluates, and continually 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 by site personnel.

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

• Manages investigator payments according to executed contract obligations, where applicable.

⛳️ Requirements

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

• 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 comprehend and apply scientific concepts related to clinical trial conduct.

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

• Demonstrates strong cross-functional collaboration skills among internal and external stakeholders.

• Exhibits strong planning and organizational skills, with the ability to work effectively in a dynamic environment with competing projects and deadlines.

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

• Possesses strong interpersonal skills, with excellent written, verbal, active listening, and presentation abilities, enabling the establishment and maintenance of site relationships and trusted partnerships through engagement, motivation, and training.

• Capable of applying functional expertise with appropriate guidance, leveraging critical thinking skills and exercising sound judgment to tackle clinical site issues.

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

• 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) for eligible employees

• Eligibility to participate in short-term incentive programs