BASIC PURPOSE OF THE JOB Responsible for the coordination and administration of clinical trials under the direction of the Principal Investigator, Research Center, and the Physicians. REPORTS TO Practice Manager JOB REQUIREMENTS Supervisory Responsibilities: NO Minimum Education: Associates degree required. Bachelors degree preferred Degree: Degree in Nursing, RN, Bachelor of Science degree in Nursing preferred. License/Certification Required: TN or Compact RN Licensure Required. Certified Clinical Research Associate preferred. Minimum Work Experience: Minimum 3 years experience in nursing required. Relative clinical experience preferred. REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES Training/experience in research methods & statistics preferred. Strong computer skills required. Computer skills to include data entry and Internet research required. Must possess excellent verbal and written communication skills as well as excellent interpersonal skills with patients, staff, and other health care professionals. DUTIES AND RESPONSIBILITIES Review research protocols prior to submittal to IRB. Administratively manages clinical trials ensuring materials are available for physician review. Assures that all patient pre study material is available and reviewed by a physician. Ensures scientific integrity of data and protects the rights, safety, and well-being of patients enrolled in clinical trials. Discusses study protocols with patients and verifies the informed consent documentation. Ensures protocols and consents are updated and IRB informed of all changes. Complies with IRB requirements regarding studies such as reporting adverse events. Follows-up on abnormal lab values and ensures physician aware. Ensures continuing review of studies are submitted to IRB in a timely manner. Assists physicians to ensure compliance with treatment plan for studies. Communicates with research centers regarding all new patients (when applicable). Collects/complies/reports data to appropriate agency for patients on clinical trials. Corresponds to principal investigators regarding IRB decisions Assists in coordination of patients placed into follow-up. Maintains knowledge of research methodology through educational programs. Integrates ethics in all areas of practice. Advocates for the protection, rights, and opportunities of patients and families. Maintains current knowledge and competency in professional practice through participation in continuing education activities. Participates in self evaluation of his/her own practice in relation to professional practice standards and guidelines through activities such as peer review and solicitation of feedback from physicians and colleagues Collaborates with inter-professional teams, leaders, stakeholders, and others to facilitate positive outcomes for patients Willingly assumes all other duties and responsibilities as necessary. Considers factors related to safety, effectiveness, and cost in regard to expected outcomes. Contributes to the budget process through planning and requests for human, financial and material resources necessary to meet identified needs. Utilizes hospital resources and time respectfully and accountably. PHYSICAL REQUIREMENTS Note: Reasonable accommodations may be made for individuals with disabilities to perform the essential functions of this position. Light lifting, pushing and pulling is required for 10-20 lbs occasionally and frequent moving of objects of less than 10 lbs is required. Frequent sitting with some walking, standing, squatting, bending and reaching is required. Keyboard/computer use and/or repetitive motions may be required. Come work where you can make a difference every day. At Dolly Parton Children’s Hospital, care is at the CORE of who we are. We are comprised of team members who live out our core values of Compassion, Ownership, Respect, and Excellence. We support each other by fostering a culture of team engagement that creates moments that matter – every interaction, every time. Compassion – We imagine what others are going through, work to alleviate suffering, and create joy whenever possible. Ownership – We take pride in our work, act with integrity, and feel personal responsibility for achieving our mission. Respect – We listen, understand, and communicate openly and politely. We recognize our diverse strengths. Excellence – We set high standards for performance in delivering the safest patient care. We give extraordinary and meaningful experiences to our patients, their families, team members, and the community we serve.

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