Clinical Cancer Research position will be responsible for the coordination of protocol subjects on cancer clinical trials under the CCTRA. This position will represent CRN interests with design and development projects for medical record templates, databases, SOP validation, treatment plan validation, and other projects as assigned by the CRN Team Lead. Position must be able to organize complex projects, provide attention to detail, and communicate effectively. Will work closely with CRN Team Lead and CRAs to manage the day-to-day operations and objectives in support of assigned portfolio. Contributes information and ideas related to areas of responsibility as part of a cross functional team. Ensures effective and efficient workflow and adherence to quality standards for staff/program and self. Position maintains a working knowledge of the Code of Federal Regulations and the code of conduct for human research. The employee will work directly with pharmaceutical company sponsors, institutional investigators, and research staff. Conducts complex work important to the organization. Contributes to measurable team and/or organization objectives.
Clinical Cancer Research RN coordinates screening, consenting, enrollment, treatment/observation, and follow-up of subjects on cancer trials. Ensures treating physicians and subjects proceed through treatment phases on schedule without deviation. Advises the PI on study and data collection requirements. Represents the department and investigators at local, regional and national meetings. Facilitates effective communication among staff, PIs, research/clinical professionals, senior leaders of UAMS, and study sponsors. Assists with development, implementation, and maintenance of quality assurance plans and develops SOPs when necessary. Serves as the general administrator and liaison for the PI, research subjects, human testing compliance, privacy/HIPAA compliance, research/clinical professionals, and the granting or funding entity relative to the research protocol. Ensures strict adherence to all regulatory requirements such as the reporting of serious adverse events in the timeline required by the study sponsor and the Institutional Review Board. Prepares high-quality written documents; analyzes data and formulates conclusions.
Maintains accurate and up-to-date clinical and research documentation as well as database information on all assigned protocol subjects. Thoroughly evaluates patients for eligibility prior to enrollment. Conducts clinical-based review of systems at appropriate patient visits and ensures all study procedures are conducted per protocol-specific requirements. Provides extensive education to patients and their caregivers/families, working closely with patients’ local physicians and assisting physicians in the management of patients. Conducts necessary measures to ensure study subjects follows strict protocol compliance. Works with CRN Team Lead and CRAs in collecting and managing patient information. Ensures information provided to CRAs for data entry is complete and accurate and assists CRAs with query resolution and monitoring/auditing visits and responses. Provides training for staff and investigators. Develop and implements process improvement and participates in the development of electronic infrastructure. Participate in on-going professional training. Customer Service: Interacts with and assists the public in a professional and friendly manner as needed. Demonstrates effective communication skills; communicates accurate and complete information; maintains strict confidentiality when necessary. Demonstrates positive working relationships with co-workers, management team, and ancillary departments; follows the Core Concepts of Patient and Family Centered Care and the Basic Code of Conduct Guidelines. Assist internal and external stakeholders as needed with exceptional customer service.
Required: Graduate of an accredited Nursing Program with a Bachelors in Nursing, or Master's in Nursing. Valid RN License, 3 years of Registered Nursing experience and/or Clinical Research experience. Must obtain CRS Certification within 2 years of hire. Excellent communication skills, basic computer skills, strong work ethics and accountability.
Preferred: 4 years or more Registered Nursing experience and/or Clinical Research experience with current BLS. Master's Degree and CCRP Certification.