Location:
Hematology Oncology of Indiana
Pay Range:
$19.66 - $34.59
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. The Clinical Research Coordinator I (non-RN) is responsible for the overall successful implementation and ongoing management of the research studies. Ability to perform basics tasks and exhibit the knowledge of key aspects of clinical research at an essential or foundational level
Primary responsibility includes study designs with entry-level complexity (phase 4, observational/registry trial design) and associated study procedures. Administratively and clinically manage an average 5 clinical trials open to accrual annually and/or active (on study treatment) patient volume 2-10 annually.
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.
KPA 1 – Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.
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.
KPA 2 – Regulatory and Data Integrity
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
KPA 3 – Research Financial Practices: Budget/Contract execution and practices research billing compliance
Identifies elements of a study budget as it relates to execution of a protocol.
Education
High school education required
Some college is preferred
Previous Experience
Prior research or related medical science experience
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.
Standard Core Workdays/Hours Monday to Friday 8:00 AM – 5:00 PM.
AON is an alliance of physicians and veteran healthcare leaders dedicated to ensuring the long-term success and viability of oncology diagnosis and treatment in community-based settings. We are the fastest growing network of community oncology practices delivering local access to exceptional cancer care.
We focus on:
- Enriching the patient experience by supporting the delivery of true value-based care through participation in the Enhancing Oncology Model and Principal Care Management programs and enhanced services, such as care coordination.
- Being 100% physician-led and governed by allowing for practice autonomy, where our partnership is collaborative and leveraged as a resource but, ultimately, what gets implemented in the practice is up to the physicians.
- Improving the lives of those who practice medicine with over 40 years of proven practice management expertise and the enablement of new revenue streams by accessing additional service lines such as clinical lab, pathology and oral oncolytic pharmacy.
The AON Difference
Practice diversification - A partnership with AON enables practice growth and access to new revenue streams through centralized ancillaries such as clinical lab, pathology and oral oncolytic pharmacy.
Economies of scale - Our ability to aggregate size and scale helps us to provide practices with the most competitive and attentive vendor services and drug pricing.
It’s a partnership - Practices deserve a partner that evolves to meet their needs and stays ahead of the industry changes. With a drive to innovate cancer care, we’re focused on the future of oncology and creating a network of industry experts to ensure accessible and patient-centered care continues to be at the forefront of healthcare.
