Clinical Research Associate II

🔥 16 hours ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

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Logo of AbbVie

AbbVie

10,000+ employees

Founded 2013

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

Healthcare • Consulting • Manufacturing

AbbVie is a global pharmaceutical company that discovers and delivers innovative medicines and solutions to enhance lives. With a focus on addressing the world's toughest health challenges, AbbVie operates in over 175 countries, providing a wide range of products across areas like immunology, oncology, neuroscience, and aesthetics. Committed to scientific innovation, AbbVie invests heavily in research and development, aiming to produce first-in-class medicines. The company also emphasizes workplace diversity, sustainability, and patient support initiatives, ensuring positive impact for both its patients and the broader community.

📋 Description

• 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, GCPs, ICH Guidelines, AbbVie SOPs and quality standards • Develop and customise site-engagement strategies for assigned studies • Gather site insights and track engagement progress and impact • Connect study protocols and scientific principles to day-to-day trial execution • Evaluate recruitment and retention techniques based on the patient disease journey • Develop therapeutic-area, asset, clinical-landscape and patient-journey knowledge • Mentor and train less experienced CRAs • 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 qualified investigators and sites • Ensure quality and timely submission of site data and safety-event reporting • Maintain audit and regulatory inspection readiness • Manage investigator payments as applicable • Report adverse events within 24 hours • Participate in AbbVie’s WHS programs and perform ad hoc administrative duties

🎯 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 in investigational drug or device trials • Experience in Healthy Volunteer and First in Patient trials highly desirable • Familiarity with risk-based monitoring, onsite and offsite monitoring • Strong cross-functional collaboration skills • Strong planning and organisational skills • Advanced ability to leverage technology, tools and resources • Strong written, verbal, active listening and presentation skills • Ability to establish and leverage site relationships and trusted partnerships • Critical thinking and good judgement to address clinical site issues • Knowledge of therapeutic area indications and scientific concepts relevant to clinical trials • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies • Flexibility to occasionally participate in business meetings outside standard hours • Adherence to AbbVie’s codes of conduct, ethics and compliance processes

🏖️ Benefits

• Flexible and supportive workplace • Flexible and accessible hiring process • Workplace accommodations for accessibility requirements • Support for employees’ right to disconnect outside working hours, subject to reasonable exceptions • Equal opportunity and inclusive workplace • Professional development through mentoring and training opportunities

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