Senior Clinical Research Nurse

About the Company

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.

About the Role

Primary role is to function as a licensed registered nurse engaged in the practice of care and assessments of healthy volunteers and patients. Position includes disseminating information to clinical research nurses (CRNs) on the unit regarding new documentation requirements, performance improvement, and PIMS upgrades. Provide study support as assigned within a defined scope to include managers, clinical research nurse coordinators (CRNC), investigators, 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.
• 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 appropriate personnel.
• Conduct nursing study-related activities as required by protocol in compliance with corporate, divisional, and department SOPs 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; facilitate resolution of source discrepancies or issues.
• 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.
• Assist with the Informed Consent process for all study subjects.
• Assist with the resolution of study-related questions and/or mitigate issues in conjunction with appropriate clinical research personnel.
• Maintain study forms/tools to facilitate accurate tracking and documentation of relevant study information.
• Provide guidance or direction for protocol-related activities; identify situations requiring further intervention and escalate appropriately.
• Perform multiple concurrent tasks with occasional interruptions.
• Train and participate in trial-related activity from initial entry to complete follow-up of patients enrolled in research protocols.
• Share knowledge and expertise through educating team members; provide training on revised and/or updated processes.
• Develop training documents (e.g., PowerPoint) and provide in-servicing and education to nursing units and lab staff regarding upcoming and ongoing protocols.
• Report adverse drug reactions and submit appropriate documentation.
• Provide direct care to research patients, including drug administration, lab draws, coordination of appointments, follow-up, and management of side effects.
• Exercise discretion and confidentiality while handling sensitive situations.
• Provide direct patient care in a professional and respectful manner.
• Apply knowledge of patient care fundamentals, including aseptic principles and techniques.

Qualifications

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

Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick).
• Medical, dental, and vision insurance.
• 401(k) retirement plan.
• Eligibility to participate in short-term incentive programs.

This job is eligible for participation in AbbVie’s short-term incentive programs.