Clinical Research Associate II

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

📋 Description

• Serve as the main point of contact for investigative sites on behalf of the Sponsor.

• Provide context for clinical trials and facilitate connections between stakeholders and investigative sites.

• Align, train, and inspire site personnel and principal investigators regarding trial objectives, protocols, and principles of patient treatment.

• Execute site evaluations, training sessions, ongoing onsite and offsite monitoring, and closure assessments.

• Ensure adherence to regulations, GCP, ICH Guidelines, AbbVie SOPs, monitoring plans, and quality standards.

• Design and tailor site-engagement strategies for the studies assigned.

• Collect local/site insights and monitor the progress and impact of engagement strategies.

• Relate study protocols and scientific principles to daily trial operations.

• Assess and ensure effective recruitment and retention techniques based on patients’ disease journeys.

• Build knowledge in therapeutic areas, assets, clinical landscapes, and patient journeys.

• Mentor and train junior CRAs and provide guidance for their development.

• Engage in global/local task forces and initiatives.

• Perform ongoing risk assessments in collaboration with the Central Monitoring team.

• Address site-risk signals and implement both preventive and corrective action plans.

• Identify and suggest potential investigators and sites.

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

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

• Oversee investigator payments in accordance with contract obligations, as applicable.

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

• Participate in AbbVie WHS programs to foster a safe working environment.

• Complete compliance training and uphold ethics and integrity.

• Undertake ad hoc administrative tasks as required.

⛳️ Requirements

• Bachelor’s degree or equivalent, preferably in a health-related field (e.g., Medical, Scientific, Nursing, Pharmacy).

• A minimum of 1 year of experience related to clinical practice.

• At least 6 months of experience in clinical research monitoring for investigational drug or device trials.

• Familiarity with risk-based monitoring, both onsite and offsite.

• Strong skills in cross-functional collaboration.

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

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

• Strong written, verbal, active listening, and presentation abilities.

• Capability to develop site relationships and trusted partnerships through engagement, motivation, and training.

• Critical thinking and sound judgment for addressing issues at clinical sites.

• Knowledge of relevant therapeutic-area indications and scientific concepts.

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

• Integrity in alignment with AbbVie’s code of business conduct.

• Willingness to occasionally attend business meetings outside of standard hours.

🏝️ Benefits

• Flexible and supportive work environment.

• Accessibility accommodations and a flexible hiring process.

• Commitment to equal opportunity and an inclusive workplace.

• Right to decline communication outside of working hours under Australia’s Right to Disconnect legislation.

• Opportunities for global/local collaboration and ongoing learning.