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 contextual information on clinical trials 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 on-site and off-site monitoring, and site closure monitoring • Ensure compliance with regulations, GCPs, ICH Guidelines, AbbVie SOPs and quality standards • Develop and customise site engagement strategies; gather local/site insights and track strategy impact • Connect study protocols and scientific principles to day-to-day trial execution • Evaluate and ensure 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 • Participate in global/local task forces and initiatives • Perform continuous risk assessment and collaborate with Central Monitoring to identify study performance or patient safety issues • Resolve site risk signals and implement preventative and corrective action plans • Identify, evaluate and recommend investigators and sites for clinical studies • Ensure quality and timely submission of site data, including safety-event reporting and follow-up • Maintain audit and regulatory inspection readiness at assigned clinical sites • Manage investigator payments as required by executed contracts • Report adverse events within 24 hours according to AbbVie policies • Participate in WHS programs and promote a safe work environment • Adhere to AbbVie codes of conduct, compliance processes and required training • Perform other administrative and ad hoc 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 in investigational drug or device trials • Experience in Healthy Volunteer and First in Patient trials highly desirable • Familiarity with risk-based monitoring approach, onsite and offsite monitoring • Strong cross-functional collaboration skills • Strong planning and organisational skills; ability to work effectively 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 apply critical thinking and good judgement to clinical site issues • Knowledge of appropriate 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 participate occasionally in business meetings outside standard hours when reasonably required for global collaboration • Acts with integrity in accordance with AbbVie code of business conduct and leadership values

🏖️ Benefits

• Flexible and supportive workplace • Flexible and accessible hiring process • Reasonable accessibility adjustments/accommodations available • Right to disconnect protections under Australia's legislation • Support for occasional flexibility in working hours for global collaboration