Clinical Research Associate II
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Job Description
Clinical Research Associate II overseeing clinical-trial sites for AbbVie, a biopharmaceutical company developing innovative medicines. Ensuring monitoring, recruitment, data quality, compliance and patient safety.
Responsibilities:
- Act as the primary Sponsor point of contact for investigative sites
- Provide clinical-trial context and connect stakeholders with investigative sites
- Align, train and motivate site staff and principal investigators on trial goals, protocols and patient-treatment principles
- Conduct site evaluation, site training, routine onsite and offsite monitoring, and site-closure monitoring
- Ensure compliance with regulations, GCP, ICH Guidelines, AbbVie SOPs, monitoring plans and quality standards
- Develop and customise site-engagement strategies for assigned studies
- Gather local/site insights and track engagement-strategy progress and impact
- Connect study protocols and scientific principles to day-to-day trial execution
- Evaluate and ensure recruitment and retention techniques based on patients’ disease journeys
- Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge
- Mentor and train less experienced CRAs and provide development input
- Participate in global/local task forces and initiatives
- Conduct continuous risk assessment with the Central Monitoring team
- Resolve site-risk signals and implement preventative and corrective action plans
- Identify and recommend potential investigators and sites
- Ensure quality and timely submission of site data, including safety-event reporting and follow-up
- Maintain audit and regulatory-inspection readiness at assigned sites
- Manage investigator payments according to contract obligations, as applicable
- Report adverse events within 24 hours according to AbbVie policies
- Participate in AbbVie WHS programs and promote a safe work environment
- Complete compliance training and maintain ethics and integrity
- Perform ad hoc administrative duties as requested
Requirements:
- Bachelor’s degree or equivalent degree; health related preferred (e.g. Medical, Scientific, Nursing, Pharmacy)
- Minimum of 1 year of clinically related experience
- At least 6 months of clinical research monitoring experience for investigational drug or device trials
- Familiarity with risk-based monitoring, onsite and offsite monitoring
- Strong cross-functional collaboration skills
- Strong planning and organisational skills; ability to manage competing projects and deadlines
- Advanced ability to leverage technology, tools and resources
- Strong written, verbal, active listening and presentation skills
- Ability to establish site relationships and trusted partnerships through engagement, motivation and training
- Critical thinking and good judgement for addressing clinical site issues
- Knowledge of relevant therapeutic-area indications and scientific concepts
- Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies
- Integrity in accordance with AbbVie’s code of business conduct
- Flexibility to occasionally participate in business meetings outside standard hours
Benefits:
- Flexible and supportive workplace
- Accessibility accommodations and flexible hiring process
- Equal opportunity and inclusive workplace
- Right to refuse contact outside working hours under Australia’s Right to Disconnect legislation
- Opportunities for global/local collaboration and continuous learning
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