A
Clinical Research Coordinator III (RN) *Sign On Bonus*
American Oncology Network
10 hours ago
Contract
On-site
Columbus, Ohio, United States
Registered Nurse
Location:
Zangmeister Cancer Center
Pay Range:
$26.83 - $45.15
JOB DESCRIPTION SUMMARY
Responsible for the performance of the research study under the medical
supervision of the Principal Investigator. Clinical Research Coordinator III
(RN) performs tasks independently, consistently and accurately, and demonstrate
that they have achieved a moderate level of expertise in all of their skills and
abilities resulting in high quality work. Responsibility includes complex types
of study designs (phase 1-3 interventional trial design) and associated study
procedures. Demonstrates working knowledge of all facets of role, relevant
regulations, and organizational and departmental policies and procedures.
Performs other duties and projects as assigned. Performs all duties in
accordance with regulatory requirements and organizational policies and
procedures.
PRIMARY KEY PERFORMANCE AREAS
KPA 1 – Protocol Comprehension and Implementation: Coordination of care for
patients on clinical research protocols in accordance with GCP, ICH/FDA
guidelines and requirements.
* Demonstrate an understanding of protocol elements / requirements and
demonstrate the ability to execute study procedures. Demonstrate the ability
to anticipate and mitigate the potential for protocol non-compliance.
* Conduct protocol feasibility assessments and complete feasibility/site
assessment questionnaires.
* Assess subjects on the basis of inclusion/exclusion criteria and demonstrate
the ability to evaluate and document subject eligibility independently.
* Reviews draft informed consent documents in compliance with regulatory
requirements and GCPs. Conduct an informed consent discussion in compliance
with SOPs.
* Review and interpret diagnostic test results and related documentation
required per protocol.
* Follows process for capturing, assessing, determining causal relationship of
adverse events to the investigational product, investigator oversight,
reporting and following up on adverse events. Recognize, report and follow up
on all types of adverse events.
* Dispense study medication in a professional and accountable manner following
protocol requirements.
* Maintain accurate records of the receipt, inventory, distribution and
destruction of study-related materials / investigational products and
research specimens.
* Ensure that the investigational drug is received, stored, and documented, and
that excess materials are returned to the sponsor according to sponsor
guidelines and in accordance with Code of Federal Regulations. Assesses and
manages investigational products that have been compromised.
KPA 2 – Regulatory and Data Integrity
* Understanding of the IRB/IEC review, key elements of review considerations,
approval and reporting requirements for the site. Complete all
IRB/IEC-related documents over the course of a clinical study. Maintains site
credentials and ensures updated GCP, licenses remain on file.
* Comply with reporting of safety related subject discontinuation and safety
concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.
* Autonomously collect, record and report accurate data and demonstrate per FDA
guidelines, and review them against the patient’s medical record for
completeness and accuracy.
* Ensure scientific integrity of data and protect the rights, safety, and
well-being of patients enrolled in clinical trials.
* Manage a monitoring visit including appropriate preparations, support,
documentation and follow up. Maintain proper (accurate and timely)
communication with the monitor and follow up on all monitor requests.
* Implement a CAPA assessment and follow CAPA related issues through to
resolution.
* Escalates issues of protocol non-compliance to study PI and research
department leadership.
KPA 3 – Research Financial Practices: Budget/Contract execution and practices
research billing compliance
* Assess a protocol and study plan to develop a study budget.
* Understanding of the payment terms of the study budget and the and tract
items that need to be invoiced for a clinical study.
POSITION QUALIFICATIONS/REQUIREMENTS
Education
* Bachelors or Associates degree in Nursing is required.
Certifications/Licenses
* Unencumbered RN License in state of employment or multi-state license.
* Valid state Driver’s License for travel to satellite offices and offsite
meetings. Compliance with the company Driver Safety Operations and Motor
Vehicle Records Check Policy is required.
Previous Experience
* 2-5 years nursing experience required, oncology preferred.
Core Capabilities
* Analysis & Critical Thinking: Critical thinking skills including solid
problem solving, analysis, decision-making, planning, time management and
organizational skills. Must be detailed oriented with the ability to exercise
independent judgment.
* Interpersonal Effectiveness: Developed interpersonal skills, emotional
intelligence, diplomacy, tact, conflict management, delegation skills, and
diversity awareness. Ability to work effectively with sensitive and
confidential material and sometimes emotionally charged matters.
* Communication Skills: Good command of the English language. Second language
is an asset but not required. Effective communication skills (oral, written,
presentation), is an active listener, and effectively provides balanced
feedback.
* Customer Service & Organizational Awareness: Strong customer focus. Ability
to build an engaging culture of quality, performance effectiveness and
operational excellence through best practices, strong business and political
acumen, collaboration and partnerships, as well as a positive employee,
physician and community relations.
* Self-Management: Effectively manages own time, conflicting priorities, self,
stress, and professional development. Self-motivated and self-starter with
ability work independently with limited supervision. Ability to work remotely
effectively as required.
* Must be able to work effectively in a fast-paced, multi-site environment with
demonstrated ability to juggle competing priorities and demands from a
variety of stakeholders and sites.
Computer Skills:
* Proficiency in MS Office Word, Excel, Power Point, and Outlook required.
* Prior experience with electronic medical records (EMR) is preferred.
* Prior experience with clinical trial data entry systems (EDC) preferred.
* Prior Clinical Trial Management Systems (CTMS) preferred.
#AONN
Zangmeister Cancer Center
Pay Range:
$26.83 - $45.15
JOB DESCRIPTION SUMMARY
Responsible for the performance of the research study under the medical
supervision of the Principal Investigator. Clinical Research Coordinator III
(RN) performs tasks independently, consistently and accurately, and demonstrate
that they have achieved a moderate level of expertise in all of their skills and
abilities resulting in high quality work. Responsibility includes complex types
of study designs (phase 1-3 interventional trial design) and associated study
procedures. Demonstrates working knowledge of all facets of role, relevant
regulations, and organizational and departmental policies and procedures.
Performs other duties and projects as assigned. Performs all duties in
accordance with regulatory requirements and organizational policies and
procedures.
PRIMARY KEY PERFORMANCE AREAS
KPA 1 – Protocol Comprehension and Implementation: Coordination of care for
patients on clinical research protocols in accordance with GCP, ICH/FDA
guidelines and requirements.
* Demonstrate an understanding of protocol elements / requirements and
demonstrate the ability to execute study procedures. Demonstrate the ability
to anticipate and mitigate the potential for protocol non-compliance.
* Conduct protocol feasibility assessments and complete feasibility/site
assessment questionnaires.
* Assess subjects on the basis of inclusion/exclusion criteria and demonstrate
the ability to evaluate and document subject eligibility independently.
* Reviews draft informed consent documents in compliance with regulatory
requirements and GCPs. Conduct an informed consent discussion in compliance
with SOPs.
* Review and interpret diagnostic test results and related documentation
required per protocol.
* Follows process for capturing, assessing, determining causal relationship of
adverse events to the investigational product, investigator oversight,
reporting and following up on adverse events. Recognize, report and follow up
on all types of adverse events.
* Dispense study medication in a professional and accountable manner following
protocol requirements.
* Maintain accurate records of the receipt, inventory, distribution and
destruction of study-related materials / investigational products and
research specimens.
* Ensure that the investigational drug is received, stored, and documented, and
that excess materials are returned to the sponsor according to sponsor
guidelines and in accordance with Code of Federal Regulations. Assesses and
manages investigational products that have been compromised.
KPA 2 – Regulatory and Data Integrity
* Understanding of the IRB/IEC review, key elements of review considerations,
approval and reporting requirements for the site. Complete all
IRB/IEC-related documents over the course of a clinical study. Maintains site
credentials and ensures updated GCP, licenses remain on file.
* Comply with reporting of safety related subject discontinuation and safety
concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.
* Autonomously collect, record and report accurate data and demonstrate per FDA
guidelines, and review them against the patient’s medical record for
completeness and accuracy.
* Ensure scientific integrity of data and protect the rights, safety, and
well-being of patients enrolled in clinical trials.
* Manage a monitoring visit including appropriate preparations, support,
documentation and follow up. Maintain proper (accurate and timely)
communication with the monitor and follow up on all monitor requests.
* Implement a CAPA assessment and follow CAPA related issues through to
resolution.
* Escalates issues of protocol non-compliance to study PI and research
department leadership.
KPA 3 – Research Financial Practices: Budget/Contract execution and practices
research billing compliance
* Assess a protocol and study plan to develop a study budget.
* Understanding of the payment terms of the study budget and the and tract
items that need to be invoiced for a clinical study.
POSITION QUALIFICATIONS/REQUIREMENTS
Education
* Bachelors or Associates degree in Nursing is required.
Certifications/Licenses
* Unencumbered RN License in state of employment or multi-state license.
* Valid state Driver’s License for travel to satellite offices and offsite
meetings. Compliance with the company Driver Safety Operations and Motor
Vehicle Records Check Policy is required.
Previous Experience
* 2-5 years nursing experience required, oncology preferred.
Core Capabilities
* Analysis & Critical Thinking: Critical thinking skills including solid
problem solving, analysis, decision-making, planning, time management and
organizational skills. Must be detailed oriented with the ability to exercise
independent judgment.
* Interpersonal Effectiveness: Developed interpersonal skills, emotional
intelligence, diplomacy, tact, conflict management, delegation skills, and
diversity awareness. Ability to work effectively with sensitive and
confidential material and sometimes emotionally charged matters.
* Communication Skills: Good command of the English language. Second language
is an asset but not required. Effective communication skills (oral, written,
presentation), is an active listener, and effectively provides balanced
feedback.
* Customer Service & Organizational Awareness: Strong customer focus. Ability
to build an engaging culture of quality, performance effectiveness and
operational excellence through best practices, strong business and political
acumen, collaboration and partnerships, as well as a positive employee,
physician and community relations.
* Self-Management: Effectively manages own time, conflicting priorities, self,
stress, and professional development. Self-motivated and self-starter with
ability work independently with limited supervision. Ability to work remotely
effectively as required.
* Must be able to work effectively in a fast-paced, multi-site environment with
demonstrated ability to juggle competing priorities and demands from a
variety of stakeholders and sites.
Computer Skills:
* Proficiency in MS Office Word, Excel, Power Point, and Outlook required.
* Prior experience with electronic medical records (EMR) is preferred.
* Prior experience with clinical trial data entry systems (EDC) preferred.
* Prior Clinical Trial Management Systems (CTMS) preferred.
#AONN