Clinical Research Associate II conducting onsite monitoring and regulatory support for PSI, a contract research organization. Managing sites, CRF review, queries, and study progress across clinical trials.
About the role
- Clinical Research Associate monitoring investigative sites and clinical trials for AbbVie’s innovative medicines pipeline. Ensuring patient safety, data integrity, compliance, and recruitment performance.
Responsibilities
- Advance AbbVie’s clinical research pipeline and support innovative medicines for patients
- Serve as the primary point of contact for investigative sites
- Provide contextual information on clinical trials and connect stakeholders with investigative sites
- Align, train, and motivate site staff and principal investigators on clinical trial goals, protocols, and patient treatment principles
- Conduct site evaluation, site training, routine monitoring, and site closure activities
- Ensure compliance with protocols, monitoring plans, regulations, Good Clinical Practices, ICH Guidelines, AbbVie SOPs, and quality standards
- Customize site engagement strategies for assigned studies
- Gather local and site insights and use CRM tools to track progress and measure impact
- Connect study protocols, scientific principles, and clinical trial requirements to day-to-day execution
- Evaluate recruitment and retention techniques based on the patient disease journey
- Develop therapeutic-area, asset, clinical-landscape, and patient-journey knowledge to support recruitment and protocol compliance
- Mentor and train less experienced CRAs and provide development input
- Participate in global or local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team to identify study-performance or patient-safety issues
- Resolve site risk signals and implement preventative and corrective action plans
- Identify, evaluate, and recommend potential investigators and sites
- Ensure quality and timely submission of site data, safety-event reporting, and follow-up
- Maintain audit and regulatory inspection readiness at assigned sites
- Manage investigator payments according to executed contract obligations, as applicable
Requirements
- Appropriate tertiary qualification in health related disciplines (Medical, Scientific, Nursing) preferred
- Minimum of 1 year of clinically related experience
- Minimum of 6 months of clinical research monitoring experience involving investigational drug or device trials
- Familiarity with risk-based monitoring approach, onsite and offsite monitoring
- Knowledge of appropriate therapeutic area indications preferred
- Ability to understand and apply scientific concepts to clinical trial conduct
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies
- Strong cross-functional collaboration skills among internal and external stakeholders
- Strong planning and organizational skills; ability to work effectively in a dynamic environment with competing projects and deadlines
- Advanced ability to leverage technology, tools, and resources
- Strong interpersonal skills with excellent written, verbal, active listening, and presentation skills
- Ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training
- Ability to use functional expertise, critical thinking, and good judgment to address clinical site issues
- Integrity in accordance with AbbVie code of business conduct and leadership values
- Self-motivated and focused on delivering timely, quality outcomes in a fast-paced environment
Benefits
- Innovative work culture
- Professional development
- Paid time off: vacation, holidays, personal days, and volunteer days
- Employee stock purchase
- Wellness spending account
- Flexible health insurance
- Retirement savings programs
- Bonus plan
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Tech skills
Location requirements
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