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American Oncology Network · 1 day ago

Clinical Research Coordinator III (RN)

US-OH-Columbus

Full-time

Onsite

Entry, Mid Level

$26.54/hr - $49.29/hr

2+ years exp

American Oncology Network is looking for a Clinical Research Coordinator III (RN) to oversee the performance of research studies under the guidance of the Principal Investigator. This role involves managing complex study designs, ensuring compliance with regulatory requirements, and maintaining data integrity throughout clinical trials.

Health CareHealth DiagnosticsMedicalOncology

H1B Sponsor Likely

Responsibilities

Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures

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

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

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

Qualification

RN LicenseOncology ExperienceClinical Trial ManagementElectronic Medical RecordsData Entry SystemsGCP ComplianceCustomer ServiceSelf-ManagementMS Office ProficiencyCritical ThinkingInterpersonal SkillsCommunication Skills

Required

Bachelors or Associates degree in Nursing is required

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

2-5 years nursing experience required, oncology preferred

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

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

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

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

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

Proficiency in MS Office Word, Excel, Power Point, and Outlook required

Preferred

Oncology experience preferred

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

Company

American Oncology Network

American Oncology Network provides support and ancillary services for oncologist and cancer patients. It is a sub-organization of Cancer & Blood Specialists of Arizona.

Founded in 2017

Fort Myers, Florida, USA

1001-5000 employees

https://www.aoncology.com/

H1B Sponsorship

American Oncology Network has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2020 (1)