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.

• Deliver information regarding clinical trials and facilitate connections between stakeholders and investigative sites.

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

• Conduct site evaluations, training sessions, routine monitoring both onsite and offsite, as well as site closure assessments.

• Ensure adherence to regulations, Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) Guidelines, AbbVie Standard Operating Procedures (SOPs), monitoring plans, and quality benchmarks.

• Create and tailor strategies for site engagement.

• Collect insights from sites and monitor the effectiveness and impact of engagement strategies.

• Relate protocol, scientific principles, and clinical trial requirements to the execution of trials.

• Assess recruitment and retention strategies based on the patient disease journey.

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

• Mentor and provide training to less experienced Clinical Research Associates (CRAs).

• Engage in global and local task forces and initiatives.

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

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

• Identify and assess potential investigators and sites.

• Ensure the quality and timely submission of site data and safety event reports.

• Maintain readiness for audits and regulatory inspections.

• Oversee investigator payments as per executed contracts when applicable.

• Report adverse events within 24 hours according to AbbVie policies.

• Engage in workplace health and safety programs.

• Uphold compliance with AbbVie’s codes of conduct and ethical standards.

• Carry out ad hoc administrative tasks.

⛳️ Requirements

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

• Minimum of 1 year of clinical experience.

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

• Experience in Healthy Volunteer and First in Patient trials is highly preferred.

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

• Capacity to work effectively and efficiently in a fast-paced environment with multiple projects and deadlines.

• Advanced capability to utilize technology, tools, and resources.

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

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

• Proficient in applying functional expertise, critical thinking, and sound judgment to resolve clinical site issues.

• Self-driven and focused on achieving timely, quality results.

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

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

• Willingness to occasionally partake in business meetings outside of standard hours.

🏝️ Benefits

• Employees are permitted to work remotely.

• A flexible and supportive work environment.

• An accommodating and accessible hiring process.

• Accessibility accommodations are available upon request.

• Right to disconnect outside working hours as per Australia’s legislation.

• Occasional flexibility for business meetings beyond standard hours.

• Commitment to equal opportunity and an inclusive workplace.