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
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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.
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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.
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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.
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Advanced understanding of site engagement and ability to customise site engagement strategy for assigned studies.
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Gather local/site insights and utilise site engagement tools to report/track progress and measure impact of that strategy.
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Connect the study protocol, scientific principles and clinical trial requirements to the day-to-day clinical trial execution activities.
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Evaluate and ensure effective recruitment and retention techniques/plans based on the patient’s disease journey.
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Develop solid knowledge of therapeutic area, asset and clinical landscape / patient journey to enable successful patient recruitment and overall protocol compliance.
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Mentor and train less experienced CRAs on various aspects of work and provides input into their development.
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Responsible for activities assigned by manager and participate in global/local task forces and initiatives.
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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.
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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.
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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.
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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.
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Audit and regulatory inspection readiness at always assigned clinical site.
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Manages investigator payments as per executed contract obligations, as applicable.
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Report any adverse event within 24 hours as per AbbVie’s policies and procedures.
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Proactively participate in AbbVie’s WHS programs, adhere to policies and promote a safe work environment at all times.
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Adhere to AbbVie’s codes of conduct and compliance processes, including timely training and maintaining ethics and integrity.
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Other ad hoc duties such as administrative duties, as requested.
Qualifications
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Appropriate tertiary qualification in health related disciplines (e.g., Medical, Scientific, Pharmacy, Nursing) preferred.
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Minimum of 3 years of clinically related experience, of which a period of 2 years is preferable in independent clinical research monitoring of investigational drug or device trials in any therapeutic area. Familiar with risk‐based monitoring approach, onsite and offsite monitoring.
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Experience in Early Phase 1 and First-in-Human healthy volunteer studies highly desirable.
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Knowledge of appropriate therapeutic area indications with the ability to understand and apply scientific concepts as they relate to the conduct of clinical trials
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Superior knowledge on existing and emerging local regulatory and legal requirements, ICH/GCP Guidelines and applicable policies.
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Demonstrate advanced communication skills and superior cross-functional collaboration skills among internal and external stakeholders.
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Demonstrate superior planning and organizational skills and the ability to work effectively and efficiently in a dynamic environment with competing projects and deadlines.
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Superior ability to leverage technology, tools and resources to provide customer centric support based on the health of the site.
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Superior interpersonal skills with excellent written, verbal, active listening and presentation skills, with ability to establish and leverage site relationships and trusted partnerships through engagement, motivation, and training.
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Ability to independently use functional expertise, leverage critical thinking skills and apply good judgement to address clinical site issues
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Acts with integrity in accordance with AbbVie code of business conduct and leadership values. Self-motivated individual focused on delivering timely and quality outcomes in a fast-paced environment
Flexibility and Availability: In line with Australia’s 'Right to Disconnect' legislation, we recognise and respect employees' right to refuse contact outside of their working hours, unless such refusal is deemed unreasonable. As we operate in an international, matrixed environment, there may be occasions where your role requires participation in business meetings outside of standard hours. We value and support flexibility and appreciate your willingness to occasionally accommodate these requests to ensure effective collaboration and communication within our global team.
Additional Information
AbbVie is an equal opportunity employer, and dedicated to fostering an inclusive, flexible, and supportive workplace that values and respects every individual. We are committed to operating with integrity, driving innovation, transforming lives, and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability. We ensure a fair and inclusive recruitment process without discrimination against any employee or applicant because of, and not limited to, race, religion, age, physical or mental disability, gender identity or expression, sexual orientation, or marital status. Our hiring process is flexible and accessible, so if you have any specific requests or accessibility requirement, please feel comfortable to let our team know by emailing [email protected] or speaking with your Recruiter and we'll make any necessary adjustments to accommodate your needs.
WAYS WE WORK
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All For One Abbvie; We weigh all decisions against the common good. We inspire, share and create as a team. We solve problems for all rather than serving our immediate team.
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Decide Smart & Sure; We make intelligent decisions to create the best outcomes. We act quickly, embrace experimentation, and learn what doesn’t work and get on to what does.
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Agile & Accountable; We streamline and eliminate unnecessary obstacles. We plan but adapt as we go. We delegate and make tough decisions to ensure focus on results, staying keenly aware of the urgency in all we do.
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Clear & Courageous; Open, honest, candid dialogue is core to our work and how we act with each other. We share information freely and continuously to find solutions. We admit mistakes. We grow stronger by putting the courage of our conviction to the test.
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Make Possibilities Real; We question with endless curiosity. We’re never satisfied with good enough—patients depend on us to deliver more. We challenge ourselves to find creative, constructive solutions to turn possibilities into reality.
CODE OF CONDUCT & BUSINESS INTEGRITY STATEMENT
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AbbVie is committed to observing high integrity and ethical standards in all its business dealings with our customers, with each other, business partners and suppliers.
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AbbVie as a responsible corporate citizen will adhere to these standards, as well as to local, national and international laws.
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All AbbVie employees are responsible for maintaining the Company’s reputation for conduct in accordance with the highest level of business integrity, ethics and compliance with the law.
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Soliciting and/or accepting/attempting/offering bribes or any illegal gratification is therefore cause for immediate dismissal.
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AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
