Clinical Research Associate II

This is a fully remote position, open to applicants in Australia.

📋 Description

• Serve as the main point of contact for sponsors at investigative sites.

• Offer contextual insights on clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, train, and inspire site staff and principal investigators regarding trial goals, protocols, and patient treatment principles.

• Conduct evaluations of sites, provide training, perform routine on-site and off-site monitoring, and manage site closure monitoring.

• Ensure adherence to regulations, GCPs, ICH Guidelines, AbbVie SOPs, and quality standards.

• Create and tailor site engagement strategies; collect local/site insights and assess the impact of these strategies.

• Link study protocols and scientific principles to the daily execution of trials.

• Assess and ensure effective recruitment and retention techniques based on the patient disease journey.

• Build knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys to enhance recruitment and protocol adherence.

• Mentor and train less experienced Clinical Research Associates (CRAs).

• Engage in global/local task forces and initiatives.

• Conduct ongoing risk assessments and partner with Central Monitoring to identify study performance or patient safety concerns.

• Address site risk signals and execute preventative and corrective action plans.

• Identify, evaluate, and recommend investigators and sites for clinical studies.

• Ensure the quality and timely submission of site data, including safety-event reporting and follow-up.

• Maintain readiness for audits and regulatory inspections at assigned clinical sites.

• Oversee investigator payments as stipulated by executed contracts.

• Report adverse events within 24 hours in accordance with AbbVie policies.

• Participate in Workplace Health and Safety (WHS) programs and foster a safe working environment.

• Comply with AbbVie codes of conduct, compliance processes, and mandatory training.

• Carry out other administrative and ad hoc tasks as required.

⛳️ Requirements

• Bachelor’s degree or equivalent; health-related fields preferred (e.g., Medical, Scientific, Nursing, Pharmacy).

• A 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 is highly desirable.

• Familiarity with risk-based monitoring approaches, both on-site and off-site.

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities; capable of managing multiple projects and deadlines effectively.

• Advanced proficiency in utilizing technology, tools, and resources.

• Strong interpersonal, written, verbal, active listening, and presentation skills.

• Ability to establish and leverage site relationships and trusted partnerships.

• Capacity for applying critical thinking and sound judgment to clinical site issues.

• Knowledge of relevant therapeutic area indications and scientific concepts related to clinical trials.

• Advanced understanding of local regulatory and legal requirements, ICH/GCP Guidelines, and applicable policies.

• Willingness to participate occasionally in business meetings outside standard hours when necessary for global collaboration.

• Conducts oneself with integrity, adhering to AbbVie’s code of business conduct and leadership values.

🏝️ Benefits

• Flexible and supportive workplace.

• Accessible and adaptable hiring process.

• Reasonable accessibility adjustments/accommodations available.

• Right to disconnect protections in line with Australia's legislation.

• Support for occasional flexibility in working hours to facilitate global collaboration.