Senior Clinical Research Associate

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

📋 Description

• Enhance AbbVie's pipeline by aiming for excellence in clinical research, transforming science into medicine for our patients, and utilizing advanced capabilities to achieve industry-leading performance.

• Collaborates with study teams, AbbVie internal R&D stakeholders, investigators, and site personnel to foster meaningful and effective partnerships, establishing AbbVie as the preferred partner in clinical trials.

• Concentrates on site clinical research to ensure the appropriate execution of trials while promoting improvements in data integrity, compliance, overall study performance, and the customer experience.

• Executes site evaluations, site training, routine on-site and off-site monitoring, and site closure monitoring activities while adhering to protocols and monitoring plans, complying with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring the safety and protection of study subjects.

• Responsible for tasks assigned by the manager.

• Continuously conducts risk assessments proactively and, in collaboration with the Central Monitoring team, oversees activities conducted by clinical sites to identify early overall study performance or patient safety concerns.

• Develops and implements effective recruitment and retention strategies based on the patient disease journey.

• Shows the ability to actively listen to and consider diverse viewpoints to enhance outcomes.

• Ensures the quality of data submitted from study sites and guarantees the prompt submission of data, including timely reporting and follow-up on all safety events by site personnel.

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

⛳️ Requirements

• Relevant tertiary qualification in health-related fields (e.g., Medical, Scientific, Pharmacy, Nursing) is preferred.

• At least 3 years of clinically related experience, with a minimum of 2 years preferably in independent clinical research monitoring of investigational drug or device trials across any therapeutic area.

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

• Knowledge of relevant therapeutic area indications with the ability to comprehend and apply scientific concepts related to the conduct of clinical trials.

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

• Exhibit advanced communication skills and exceptional cross-functional collaboration abilities among internal and external stakeholders.

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

• Strong ability to utilize technology, tools, and resources to provide customer-centric support based on the health of the site.

• Excellent interpersonal skills, including strong written, verbal, active listening, and presentation abilities, with the capacity to establish and maintain site relationships and trusted partnerships through engagement, motivation, and training.

• Ability to independently apply functional expertise, utilize critical thinking skills, and exercise good judgment to resolve clinical site issues.

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

• Self-motivated individual dedicated to delivering timely and quality outcomes in a fast-paced environment.

🏝️ Benefits

• Paid time off (vacation, holidays, sick)

• Medical/dental/vision insurance

• 401(k)