Company Description

About AbbVie

AbbVie's mission is to discover and deliver cutting-edge medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Join AbbVie's Expanding Clinical Operations Team

At AbbVie, we are committed to discovering and delivering innovative medicines that solve serious health issues today while addressing the medical challenges of tomorrow.

We're looking for a Clinical Research Associate I (CRA I) to join our growing team in Australia and help advance clinical studies that have the potential to transform patient outcomes. This is an opportunity to become part of a growing team supporting a strong pipeline and diverse portfolio of clinical programs across multiple therapeutic areas, while building a long-term career with one of the world's leading biopharmaceutical companies.

If you're looking for more than just your next role and want the opportunity to broaden your experience and contribute to innovative clinical development programs, we'd love to hear from you.

KEY DUTIES AND RESPONSIBILITIES

- Monitors activities conducted by clinical investigative sites as they relate to AbbVie clinical studies to ensure successful execution of the protocol. Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs),



Monitoring Plans, and quality standards in conducting clinical research.
- Conducts site qualification, initiation, interim monitoring and study closeout visits for Phase 1-4 studies in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, and AbbVie Standard Operating Procedures (SOPs) and business processes.
- Overviews the overall activities of site personnel over whom there is no direct authority and motivates/influences them to meet study objectives. proactively manages the site and ensures action plans are put into place as needed to ensure compliance. Ensures regulatory inspection readiness at assigned clinical sites.
- Ensures quality of data submitted from study sites and ensures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel.
- Ensures safety and protection of study subjects through compliance with the study monitoring plan, AbbVie SOPs, ICH Guidelines, and applicable regulations.
- Trains study site personnel on the protocol and applicable regulatory requirements in collaboration with pertinent project team members.
- Manage investigator payments as per executed contract obligations. Maintain and complete own expense reports as per local and applicable guidelines.
- Identifies,



evaluates and recommends new/potential investigators/sites on an ongoing basis. Potential sites may be identified through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators.
- 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 setting 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

- Appropriate tertiary qualification, health related (e.g., Medical, Scientific, Nursing) preferred.
- Minimum of 1 year of clinically related experience, of which a period of 6 months is preferable incl. clinical research monitoring. Experience in on-site monitoring of investigational drug or device trials are required.
- Current in-depth knowledge and understanding of appropriate therapeutic indications as they relate to the conduct of clinical trials.
- Current in-depth knowledge of regulations governing clinical research, ICH/GCP Guidelines and applicable regulations.
- Strong planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
- Ability to work, understand and follow work processes within the assigned function.
- Strong analytical and conceptual capabilities, interpersonal skills, and ability to communicate with clarity.
- Ability to address study related clinical site issues with appropriate guidance and initiates and communicate corrective action as indicated.
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📌 Clinical Research Associate I (Sydney)
🏢 Abbvie
📍 Sydney