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Senior Clinical Research Associate

AbbVie

RemoteSydney, NSW, AustraliaFull TimeMidH-1B sponsor company
Sign in to applyVerified 2h ago
Location
Sydney, NSW, Australia
Employment
Full Time
Work model
Remote
Level
Mid
H-1B history
94 approvals (FY2023)
Posted
2h ago

Skills

GCP

About this role

Company Description

About AbbVie AbbVie's mission is to discover and deliver innovative 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

AbbVie is seeking a driven and detail-oriented Senior Clinical Research Associate to join our world-class clinical development team, where you will play a pivotal role in advancing life-changing therapies by overseeing and monitoring clinical trial sites to ensure the highest standards of quality, compliance, and patient safety. The ideal candidate brings a strong foundation in ICH/GCP guidelines, proven site management expertise, and the collaborative spirit to thrive in a fast-paced, science-driven environment dedicated to making a remarkable impact on patients' lives. KEY DUTIES AND RESPONSIBILTIES Act as the primary Sponsor point of contact for the investigative site, providing contextual information on the clinical trials, connecting stakeholders to the investigative sites and strengthening AbbVie’s positioning. Aligns, trains and motivates the site staff and principal investigator on the goals of the clinical trial program, protocol and patient treatment principles for the trial ensuring a trusted partnership. Conduct site evaluation, site training, routine on-site and off-site monitoring, and site closure monitoring activities with compliance, protocol and monitoring plans, in accordance with applicable regulations, Good Clinical Practices (GCPs), ICH Guidelines, AbbVie Standard Operating Procedures (SOPs), and quality standards, ensuring safety and protection of study subjects. Advanced understanding of site engagement and ability to customise site engagement strategy for assigned studies. Gather local/site insights and utilise site engagement tools to report/track progress and measure impact of that strategy. Connect 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’s disease journey. Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance. Mentor and train less experienced CRAs on various aspects of work and provides input into their development. Responsible for activities assigned by manager and participate in global/local task forces and initiatives. Proactively responsible for continuous risk-assessment, and in collaboration with Central Monitoring team, monitor activities conducted by clinical sites to detect early overall study performance or patient safety issues. Resolves site risk signals while having a robust understanding of site processes to drive study execution, ensuring preventative and corrective action plans are put into place, as needed, to mitigate risk and promote compliance using a customer centric approach. Identifies, evaluates and recommends new/potential investigators/sites on an ongoing basis through networking or internal AbbVie requests to assist in the placement of planned clinical studies with qualified investigators. Ensures quality of data submitted from study sites and assures timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. Audit and regulatory inspection readiness at always assigned clinical site. Manages investigator payments as per executed contract obligations, as applicable. Report any adverse event within 24 hours as

Senior Clinical Research Associate at AbbVie, Sydney, NSW, Australia | Yoinka