NC - RN Clinical Research Coordinator - Asheville

Job Description Summary:

Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) p erforms 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

1. 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

2. Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.

3. 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

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

5. 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

6. Implement a CAPA assessment and follow CAPA related issues through to resolution.

7. 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

1. Assess a protocol and study plan to develop a study budget.

2. 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

1. Education :.

• High school education required

• ASN or BSN required

2. Certifications/Licenses :

• Registered Nurse

• 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.

3. Previous Experience :

· 2-5 years nursing experience required, oncology preferred

4. 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.

5. Travel (double click to check relevant box): 0% <25% 26-50% 51%-75% >75%

6. Standard Core Workdays/Hours (specify weekends and call requirements) : Monday to Friday 8:00 AM – 5:00 PM.

7. Essential Physical Requirements : refer to last page of job description for job specific physical and mental requirements.

Expectations for all Employees

Every AON employee is expected to regularly conduct themselves in a professional and respectful manner, to comply with all labor laws, workplace policy and workplace practices. Employees are expected to bring issues of any forms of workplace harassment, discrimination or other potential improprieties to the attention of their management or the human resources department.

AON has defined and adopted a set of C.A.R.E values that every employee is expected to follow. They are:

C ontinuously Support the Patient/Customer.

Our team delivers results by providing compassionate oncology and hematology services with continued focus on the patient.

A lways Do the Right Thing.

We are committed to personal excellence, accountability, and integrity. We abide by the highest regulatory standards, perform in the most ethical manner, and take responsibility for our actions.

R espectfully Engage.

We foster positive relationships, encourage diversity of thought, and promote trust among our teams and customers. We encourage healthy debate and respect the thoughts and opinions of others. We believe that the talent, skills and expertise of our people are our most important assets.

E xceed Expectations.

We strive to provide excellence in all that we do. We create a standard of caring that goes above and beyond while embracing change in support of continuous improvement for our patients.