Clinical research associate i (melbourne)

Clinical Research Associate I

Location: Melbourne, VIC

Function: Research & Development

Job Type: Full-time

Job Description

The Clinical Research Associate I (CRA I) is responsible for supporting the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory guidelines, protocols, and quality standards. The CRA I assists in site selection, initiation, and monitoring visits, reviews study documentation and data for accuracy and completeness, liaises with site staff to address study-related issues, ensures the safety and well-being of study participants, maintains essential study files and assists in the preparation and submission of study documents.

The role requires strong organisational skills, attention to detail, effective communication, and a foundational understanding of Good Clinical Practice (GCP) and relevant regulations. It is expected to entail up to 80% travel inter-state or overseas as required.

Key Duties and Responsibilities

• Act as the primary point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholder to the investigative sites and strengthening AbbVie's positioning.
• Align, train and motivate the site staff and principal investigator under supervision on the goals of the clinical trial program, protocol, and patient treatment principles for the trial ensuring a trusted partnership.
• Customise site engagement strategy for assigned studies under supervision and gather local/site insights and utilise site engagement tools such as the Customer Relationship Management (CRM) tool, to report/track progress and measure impact of that strategy.
• Fundamental level of competency connecting the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
• Evaluate and ensure effective recruitment and retention techniques/plans based on the patient disease journey.
• Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
• Responsible for continuous risk-assessment proactively, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues.
• Think critically to resolve site risk signals while having robust understanding of site processes to drive study execution.
• Ensure preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach.
• Identify, evaluate and recommend new/potential investigators/sites under supervision and support from more experienced CRAs.
• Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
• Ensure audit and regulatory inspection readiness at assigned clinical site at all times. Manage investigator payments as per executed contract obligations, as applicable.
• Report any adverse event within 24 hours as per AbbVie's policies and procedures.
• Proactively participate in AbbVie's WHS programs, adhere to policies and promote a safe work environment at all times.
• Adhere to AbbVie's internal codes of conduct and compliance processes.
• Other ad hoc duties such as administrative duties, as requested.

Qualifications

• Tertiary qualification in health related discipline (Medical, Scientific, Nursing).
• Knowledge of existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
• Clinically related experience, preferably in clinical research coordinating or data management.
• Able to work collaboratively and cross functionally to develop and sustain working relationships.
• Demonstrate planning and organisational skills and the ability to work effectively and efficiently in an energetic environment with competing projects and deadlines.
• Interpersonal skills with strong written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation and training.

Flexibility and Availability

In line with Australia's "Right to Disconnect" legislation.