Senior Clinical Research Associate – Oncology

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

📋 Description

• Propel AbbVie’s clinical research pipeline while supporting innovative medications and solutions

• Collaborate with study teams, internal R&D stakeholders, investigators, and site personnel

• Act as the primary sponsor liaison for investigative sites

• Align, instruct, and inspire site staff and principal investigators regarding trial objectives, protocols, and patient treatment principles

• Provide support, guidance, and mentorship to junior personnel and Clinical Research Associates (CRAs)

• Conduct evaluations of sites, training sessions, routine onsite and offsite monitoring, and closure monitoring of sites

• Ensure adherence to protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards

• Develop and implement site engagement strategies and assess their effectiveness

• Assist in recruitment and retention strategies based on the patient's disease journey

• Cultivate understanding of the therapeutic area, asset, clinical landscape, and patient journey

• Engage in or lead global and local task forces and initiatives

• Conduct ongoing risk assessments in collaboration with the Central Monitoring team

• Address site risk signals and enact preventative and corrective action plans

• Identify, assess, and propose potential investigators and sites

• Guarantee the quality and timely submission of site data and safety-event reports

• Maintain readiness for audits and regulatory inspections at designated sites

• Oversee investigator payments in accordance with contract obligations, when applicable

⛳️ Requirements

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

• A minimum of 3 years of clinically relevant experience

• Ideally, 2 years of independent clinical research monitoring experience with investigational drug or device trials

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

• Understanding of therapeutic area indications and scientific concepts associated with clinical trials

• Knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies

• Advanced communication skills and ability to work collaboratively across functions

• Exceptional planning and organizational abilities

• Capability to operate effectively in a dynamic environment with competing projects and deadlines

• Proficiency in leveraging technology, tools, and resources

• Outstanding written, verbal, active listening, and presentation skills

• Ability to cultivate and maintain site relationships and trusted partnerships

• Skill in independently resolving clinical site issues using functional expertise, critical thinking, and sound judgment

• Adherence to integrity in alignment with AbbVie’s code of business conduct and leadership values

• Self-driven and focused on achieving timely, high-quality outcomes

• Willingness to travel up to 75% of the time

🏝️ Benefits

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

• Medical, dental, and vision insurance

• 401(k) retirement plan

• Short-term incentive programs

• Option for remote work