Senior Clinical Research Associate
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Job Description
Senior Clinical Research Associate advancing AbbVie’s oncology clinical trials at AbbVie. Monitoring sites, protecting data integrity, ensuring compliance, and mentoring junior CRAs.
Responsibilities:
- Advance AbbVie’s oncology clinical research pipeline and support innovative medicines and solutions
- Partner with study teams, internal R&D stakeholders, investigators, and site staff
- Serve as the primary sponsor point of contact for investigative sites
- Align, train, and motivate site staff and principal investigators on trial goals, protocols, and patient-treatment principles
- Support, guide, and mentor junior personnel and CRAs on site-management activities
- Conduct site evaluation, site training, routine onsite/offsite monitoring, and site-closure monitoring
- Ensure compliance with protocols, monitoring plans, regulations, GCP, ICH Guidelines, SOPs, and quality standards
- Develop and customize site-engagement strategies; gather site insights and track strategy impact
- Develop recruitment and retention techniques based on the patient disease journey
- Participate in or lead global/local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team and address site risk signals
- Implement preventative and corrective action plans to mitigate risk and promote compliance
- Identify, evaluate, and recommend potential investigators and sites
- Ensure quality and timely submission of site data and safety-event reporting
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contract obligations, as applicable
Requirements:
- Minimum of 3 years of clinically related experience
- Preferably 2 years of independent clinical research monitoring experience for investigational drug or device trials
- Appropriate tertiary qualification in a health-related discipline (e.g., Medical, Scientific, Pharmacy, Nursing) preferred
- Familiarity with risk-based monitoring and onsite/offsite monitoring
- Knowledge of therapeutic-area indications and scientific concepts relevant to clinical trials
- Superior knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Advanced communication and cross-functional collaboration skills
- Superior planning and organizational skills; ability to manage competing projects and deadlines
- Ability to leverage technology, tools, and resources for customer-centric site support
- Superior interpersonal, written, verbal, active listening, and presentation skills
- Ability to independently address clinical site issues using functional expertise, critical thinking, and judgment
- Integrity consistent with AbbVie’s code of business conduct and leadership values
- Self-motivated and focused on timely, quality outcomes in a fast-paced environment
Benefits:
- Employees can work remotely
- Equal opportunity employer
- Commitment to operating with integrity, driving innovation, transforming lives and serving the community
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