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American Oncology Network · 4 hours ago

Clinical Research Coordinator

US-WA-Olympia

Full-time

Onsite

New Grad, Entry Level

$22.46/hr - $39.51/hr

American Oncology Network is a company focused on oncology care, and they are seeking a Clinical Research Coordinator to manage clinical trials. The role involves coordinating patient care on research protocols, ensuring regulatory compliance, and maintaining data integrity throughout the research process.

Health CareHealth DiagnosticsMedicalOncology

H1B Sponsor Likely

Responsibilities

Identify and explain key protocol elements and perform study tasks under direct supervision

Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires

Identifies and explains inclusion/exclusion criteria and the process of subject identification, prescreening, screening and re-screening

Knowledge of the required elements of an informed consent form and the essential elements of the informed consent process

Review of diagnostic tests 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. Document different types of adverse events under direct supervision

Ensures proper storage, dispensing, handling and destruction processes for investigational products

Follows process for handling investigational products that have been compromised

Follows Institutional Review Board (IRB) / Independent Ethics Committee (IEC) review, approval and reporting requirements for the site. 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

Collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient’s medical record for completeness and accuracy under direct supervision

Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials

Prepare documents for monitoring visits under direct supervision. Review visit monitoring follow-up reports / letters and perform requested activities

Escalates issues of protocol non-compliance to study PI and research department leadership

Identifies elements of a study budget as it relates to execution of a protocol

Qualification

Clinical trial managementRegulatory complianceData integrityElectronic medical recordsClinical trial data entryCritical thinkingCommunication skillsCustomer serviceSelf-managementMS Office proficiencyInterpersonal skills

Required

High school education required

Prior research or related medical science experience

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

Effective communication skills (oral, written, presentation)

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

Some college is preferred

Second language is an asset but not 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

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)