What are the responsibilities and job description for the Clinical Research Nurse position at BioSpace?
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.
Purpose
Job Description
The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clinical research study. Research nurses should primarily be concerned with the protection and care of research subjects. The primary role is to function as a licensed registered nurse engaged in the practice of care/assessments of the healthy volunteers and/or patient. Position includes disseminating information regarding new information for documentation, performance improvement and data source upgrades.
Responsibilities
Review protocols and informed consent forms for scheduled studies, identify and communicate potential issues to the appropriate personnel.
Participate in nursing study related activities as required by protocol compliance with Corporate, divisional, and departmental SOP’s and external (CFR, ICH GCP) regulatory guidelines. Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.
Evaluate adverse events and manage safety reporting activities in a timely manner.
Interact with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel in support of study-specific activities.
Support quality and compliance improvement initiatives as appropriate.
Participate in the recruitment and screening activities to ensure successful enrollment of volunteers into studies scheduled at the Phase 1 Unit. Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol. Review and assess data collected. Serve as a resource person or act as a consultant within area of clinical expertise (R/S).
Disburses investigational drug and provides teaching regarding administration, as necessary. Develops accurate source materials and ensures compliance from site staff. Ensures all protocol procedures are completed per study requirements (Unit).
Qualifications
Qualifications:
For Recruiting & Screening: Minimum of a diploma from an accredited nursing school and 1-3 years work experience in a clinical research environmentFor Unit: Bachelor of Nursing or other Science degree preferred with 1-3 years of nursing experience in a hospital setting; and/or ER/ICU experience
Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, administering injections, etc.)
Fundamental working knowledge of clinical research
Advanced Life Support and Cardio-Pulmonary Resuscitation within six months
Ability to organize and prioritize responsibilities while paying close attention to detail
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.
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
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.
Purpose
Job Description
The Clinical Research Nurse is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). Assists with the execution of study-related activities of a Phase I clinical research study. Research nurses should primarily be concerned with the protection and care of research subjects. The primary role is to function as a licensed registered nurse engaged in the practice of care/assessments of the healthy volunteers and/or patient. Position includes disseminating information regarding new information for documentation, performance improvement and data source upgrades.
Responsibilities
Review protocols and informed consent forms for scheduled studies, identify and communicate potential issues to the appropriate personnel.
Participate in nursing study related activities as required by protocol compliance with Corporate, divisional, and departmental SOP’s and external (CFR, ICH GCP) regulatory guidelines. Responsible for compliance with applicable Corporate and Divisional Policies and Procedures.
Evaluate adverse events and manage safety reporting activities in a timely manner.
Interact with the Principal Investigator and other study physicians, Recruiting/Screening, Data Systems, and other personnel in support of study-specific activities.
Support quality and compliance improvement initiatives as appropriate.
Participate in the recruitment and screening activities to ensure successful enrollment of volunteers into studies scheduled at the Phase 1 Unit. Interfaces with research participants to support efforts to determine eligibility and consenting of study participants according to protocol. Review and assess data collected. Serve as a resource person or act as a consultant within area of clinical expertise (R/S).
Disburses investigational drug and provides teaching regarding administration, as necessary. Develops accurate source materials and ensures compliance from site staff. Ensures all protocol procedures are completed per study requirements (Unit).
Qualifications
Qualifications:
For Recruiting & Screening: Minimum of a diploma from an accredited nursing school and 1-3 years work experience in a clinical research environmentFor Unit: Bachelor of Nursing or other Science degree preferred with 1-3 years of nursing experience in a hospital setting; and/or ER/ICU experience
Nursing competency skills per scope of practice (i.e., performing vital signs, nursing assessments, performing ECG/EKG, administering injections, etc.)
Fundamental working knowledge of clinical research
Advanced Life Support and Cardio-Pulmonary Resuscitation within six months
Ability to organize and prioritize responsibilities while paying close attention to detail
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.
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