Senior Clinical Research Associate

📋 Description

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

• Collaborates with study teams, internal R&D stakeholders at AbbVie, investigators, and site staff to foster meaningful and effective partnerships.

• Concentrates on site clinical research to ensure proper trial conduct while promoting improvements in data integrity, compliance, overall study performance, and customer experience.

• Recognized as the Primary Sponsor Point of contact for the investigative site.

• Possesses advanced competency or experience in providing relevant information on clinical trials.

• Capable of inspiring and aligning the monitoring community through leadership and mentorship.

• Trains, aligns, and motivates site staff and principal investigators on the objectives of the clinical trial program.

• Assists, guides, and mentors junior staff on Site Management tasks.

• Performs site evaluations, site training, routine on-site and off-site monitoring, and site closure monitoring activities.

• Collects local/site insights and utilizes site engagement tools to report/track progress and assess the impact of strategies.

• Ensures the quality of data submitted from study sites and guarantees timely data submission.

• Independently identifies, assesses, and recommends new or potential investigators/sites on an ongoing basis.

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

⛳️ Requirements

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

• At least 3 years of clinically related experience, with a preferable total of 5 years 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 capacity to understand and apply scientific concepts related to clinical trial conduct.

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

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

• Exhibits superior planning and organizational skills and the ability to operate effectively and efficiently in a dynamic environment with competing projects and deadlines.

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

• Excellent interpersonal skills with strong written, verbal, active listening, and presentation abilities.

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

• 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

• Health insurance.

• Professional development.