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.

• Offer context related to clinical trials and facilitate connections between stakeholders and investigative sites.

• Train, align, and motivate site personnel and principal investigators regarding trial objectives, protocols, and patient-treatment principles.

• Perform site evaluations, training sessions, routine monitoring both onsite and offsite, and closure monitoring for sites.

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

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

• Collect insights from sites and monitor engagement progress and its impact.

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

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

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

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

• Engage in global and local task forces and initiatives.

• Conduct ongoing risk assessments with the Central Monitoring team.

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

• Identify and suggest qualified investigators and sites.

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

• Maintain readiness for audits and regulatory inspections.

• Manage investigator payments as necessary.

• Report adverse events within a 24-hour timeframe.

• Take part in AbbVie’s Workplace Health and Safety (WHS) programs and carry out ad hoc administrative tasks.

⛳️ Requirements

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

• At least 1 year of experience in a clinically related role.

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

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

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

• Strong skills in cross-functional collaboration.

• Excellent planning and organizational abilities.

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

• Strong written, verbal, and active listening skills, along with effective presentation abilities.

• Capability to build and leverage relationships and trusted partnerships at sites.

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

• Understanding of therapeutic area indications and scientific concepts pertinent to clinical trials.

• Advanced knowledge of local regulatory and legal requirements, ICH/GCP Guidelines, and relevant policies.

• Flexibility to occasionally attend business meetings beyond standard working hours.

• Commitment to AbbVie’s codes of conduct, ethics, and compliance processes.

🏝️ Benefits

• A flexible and supportive work environment.

• An adaptable and accessible hiring process.

• Workplace accommodations for accessibility needs.

• Support for employees' right to disconnect after working hours, with reasonable exceptions.

• A commitment to equal opportunity and an inclusive workplace.

• Opportunities for professional development through mentoring and training programs.