Senior Clinical Research Nurse

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

Primary role is to function as a licensed registered nurse engaged in the practice of care/assessments of the healthy volunteers and patients. Position includes disseminating information to CRN's on the unit regarding new information for documentation, performance improvement and PIMS upgrades. Provide study support as assigned within a defined scope to include managers, clinical research nurse coordinators (CRNC), investigators and sub-investigators, unit personnel, and other ancillary staff.

Responsibilities

• Facilitate and participate in the execution of study-related activities of a Phase I clinical research study conducted at the Phase I Unit in relation to areas of responsibility. Maintain safety and confidentiality of study subjects throughout the study. Evaluate adverse events and manage safety reporting activities in a timely manner. Review protocols and informed consent forms for scheduled studies. Identify and communicate potential issues to the appropriate personnel.
• Conduct nursing study related activities as required by protocol in compliance with corporate, divisional, and department SOP’s and external (CFR, ICH, GCP) regulatory guidelines. Interact with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel to organize study-specific nursing activities.
• Participate in quality and compliance improvement initiatives and provide feedback as a nursing subject matter expert. Maintain accurate and complete source data in PIMS and/or other source documents and facilitate the resolution of source discrepancies or issues, as appropriate.
• Assist with protocol-specific training for study personnel in preparation for study activities. Facilitate training of new nursing personnel and ensure management is apprised of trainee progress. Recognize and implement changes to the activity schedule based on the strategic plan. Assists with the Informed Consent process for all study subjects.
• Assists with the resolution of study related questions and/or mitigate issues in conjunction with appropriate clinical research personnel. Assists with maintaining study forms/tools to facilitate accurate tracking and documentation of relevant study information.
• Ability to provide guidance or direction for protocol related activities. Identifies situations that require further intervention and escalates appropriately. Ability to perform multiple concurrent tasks with occasional interruptions required.
• Trains and participates in trial related activity from the initial entry to complete follow-up of patients enrolled into research protocols. Shares knowledge and expertise through educating team members. Provides training on revised and/or updated processes and updates nursing staff accordingly. Develops training documents (powerpoint, etc). Provides in-servicing and educating both the nursing units and lab staff regarding upcoming and ongoing protocols.
• Reports adverse drug reactions and submits the appropriate documentation.
• Provide direct care to research patients, including drug administration, lab draws, coordination of appointments, follow-up and management of side effects. Ability to exercise discretion and confidentiality while handling sensitive situations required.
• Ability to provide direct patient care in a professional and respectful manner required. Knowledge of patient care fundamentals, including aseptic principles and techniques required. Ability to read documents or instruments required.

Qualifications

• Associate Degree in Nursing, Baccalaureate preferred. 5 or more years of nursing experience; and/or has >4 years of work experience in a clinical research environment.

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 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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

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