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ACPRU Clinical Research Nurse
1 month ago
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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Job Description
Job Description- Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Review protocols and informed consent forms for scheduled studies, identify, and communicate potential issues to the appropriate personnel.
- Participate in the execution of study-related activities of Phase I clinical research studies conducted at the ACPRU.
- Maintain safety and confidentiality of study subjects throughout the study. Maintain accurate and complete source data.
- Evaluate adverse events and manage safety reporting activities in a timely manner.
- Participate in nursing study related activities as required by protocol in compliance with corporate, divisional, and departmental SOP's and external (CFR, ICH, GCP) regulatory guidelines.
- Communicate with the Principal Investigator and other ACPRU personnel to organize study-specific nursing activities.
- Participate in quality and compliance improvement initiatives and provide feedback as appropriate.
- Facilitate training of new nursing personnel and ensure management is apprised of trainee progress.
- Provides study support as assigned within a defined scope, actively supports area projects/goals and completes delegated activities as assigned. Workload responsibilities are study-related and have a major impact on regulatory compliance.
- The candidate must be able to present study related issues, orally and in writing, in a clear and concise manner. Problem solving involves identification of problems and proper escalation to Management. Follows scientific arguments and identifies study data and source document issues and seeks solutions with minimum guidance. Complies with proper documentation practices and utilizes sound GCP standards and regulatory guidance. Impacts subject safety, study data integrity, and product approval.
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Qualifications
This position will work 3rd shift 10:45pm-7:15am CST, Thursday, Friday, and Saturday - with rotation as needed. This position will also be on-site.
Qualifications- Associate Degree in Nursing; R.N. licensure in Illinois or ability to become registered in Illinois.
- 3-4 years of nursing experience; and/or 1-3 years of work experience in a clinical research environment.
- Good understanding of ICH/FDA regulations and guidelines affecting clinical research issues. Understanding of department SOPs. Clinical knowledge to apply to adverse event assessment and data collection. Computer proficient (eg Windows, Word, Excel).
- Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance. Creates a learning environment, open to suggestions and experimentation for improvement. Embraces the ideas of others, nurtures innovation and manages innovation to reality.
- Learns fast, grasps the essence" and can change course quickly where indicated. Raises the bar and is never satisfied with the status quo.
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is a considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status
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