Clinical Research Nurse
Job Description
Eligible for Sign on Bonus
Summary:
The Cancer Research Nurse is responsible for the day-to-day management of research trials through close out.
Responsibilities:
Participates in the informed consent process of study subjects at all NL EMMC participating sites to include screening all new patients daily -determines preliminary eligibility- informs physician- follows through with patients for possible entry into clinical trial.
Supports the safety of clinical research patients/research participants
Coordinates protocol related research procedures, study visits, and follow-up care with all participating sites
Screens, recruits and enrolls research participants
Maintains study source documents
Reports adverse events
Understands and is compliant with good clinical practice (GCP) and regulatory compliance with CITI training completion
Educates staff at remote NL EMMC participating sites on protocol, study intervention, study drug, etc.
Educates subjects and family on protocol, study intervention, study drug, etc.
Complies with Institutional policies, standard operating procedures (SOPs) and guidelines
Works closely with clinical trials team to identify, implement and successfully conduct cooperative group, industry, and investigator-led clinical trials.
Ensures financial, operational, accrual and other strategic targets are met. Develops and implements corrective action plans as necessary to improve productivity, quality and/or process workflows.
Works closely with physicians and study teams at all participating sites to ensure efficient and timely implementation of new genomic trials and ensures and maintains ongoing compliance with company policies and procedures, SOPs, ICH/GCP guidelines, and FDA regulations.
Brings oncology research subject matter expertise to the planning and execution of study start-up processes, to include remote NL EMMC participating sites, including:
-- study feasibility,
-- Medicare Coverage Analysis development (SOC vs NSOC assessments) and study budget negotiations
-- Study startup operational efficiency and effectiveness
Participates in the development of policies and procedures, and other tools to support the studies with the research manager
May represent the interests of the oncology research program at local/national meetings and educational conferences pertinent to public relations and future business development.
Other Information:
Credentials
Education
Summary:
The Cancer Research Nurse is responsible for the day-to-day management of research trials through close out.
Responsibilities:
Participates in the informed consent process of study subjects at all NL EMMC participating sites to include screening all new patients daily -determines preliminary eligibility- informs physician- follows through with patients for possible entry into clinical trial.
Supports the safety of clinical research patients/research participants
Coordinates protocol related research procedures, study visits, and follow-up care with all participating sites
Screens, recruits and enrolls research participants
Maintains study source documents
Reports adverse events
Understands and is compliant with good clinical practice (GCP) and regulatory compliance with CITI training completion
Educates staff at remote NL EMMC participating sites on protocol, study intervention, study drug, etc.
Educates subjects and family on protocol, study intervention, study drug, etc.
Complies with Institutional policies, standard operating procedures (SOPs) and guidelines
Works closely with clinical trials team to identify, implement and successfully conduct cooperative group, industry, and investigator-led clinical trials.
Ensures financial, operational, accrual and other strategic targets are met. Develops and implements corrective action plans as necessary to improve productivity, quality and/or process workflows.
Works closely with physicians and study teams at all participating sites to ensure efficient and timely implementation of new genomic trials and ensures and maintains ongoing compliance with company policies and procedures, SOPs, ICH/GCP guidelines, and FDA regulations.
Brings oncology research subject matter expertise to the planning and execution of study start-up processes, to include remote NL EMMC participating sites, including:
-- study feasibility,
-- Medicare Coverage Analysis development (SOC vs NSOC assessments) and study budget negotiations
-- Study startup operational efficiency and effectiveness
Participates in the development of policies and procedures, and other tools to support the studies with the research manager
May represent the interests of the oncology research program at local/national meetings and educational conferences pertinent to public relations and future business development.
Other Information:
- BLS Required.
- Exceptional organizational and clinical research management skills
- Excellent interpersonal skills with the ability to build strong relationships across multiple organizations
- Excellent time management, critical thinking, analytical and problem-solving skills
- Advanced computer skills, including CTMS, EDC, document management systems, databases and Microsoft Office suite
Credentials
- Required Registered - with current OCN or CRA/CRC certification preferred (ACRP or SoCRA)
Education
- BS degree in life sciences or related research field required (advanced degrees preferred)
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