Clinical Research Associate II

🔥 16 hours ago

🇦🇺 Australia – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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AbbVie

WebsiteLinkedInAll Job Openings

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 information 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, monitoring plans, and quality standards • Develop and customize site engagement strategies • Gather site insights and track engagement strategy progress and impact • Connect protocol, scientific principles, and clinical trial requirements to trial execution • Evaluate recruitment and retention techniques based on patient disease journeys • 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 evaluate potential investigators and sites • Ensure quality and timely submission of site data and safety-event reporting • Maintain audit and regulatory inspection readiness • Manage investigator payments according to executed contracts, as applicable • Report adverse events within 24 hours according to AbbVie policies • Participate in workplace health and safety programs • Maintain compliance with AbbVie codes of conduct and ethics requirements • 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 for 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 • Ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines • Advanced ability to leverage technology, tools and resources • Strong interpersonal, written, verbal, active listening, and presentation skills • Ability to establish and leverage site relationships and trusted partnerships • Ability to use functional expertise, critical thinking, and good judgment to address clinical site issues • Self-motivated and focused on timely, quality outcomes • Knowledge of relevant therapeutic area indications and scientific concepts related to clinical trials • Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies • Ability to occasionally participate in business meetings outside standard hours

🏖️ Benefits

• Employees can work remotely • Flexible and supportive workplace • Flexible and accessible hiring process • Accessibility accommodations available upon request • Right to disconnect outside working hours under Australia’s legislation • Occasional flexibility for business meetings outside standard hours • Equal opportunity and inclusive workplace