Clinical Support Specialist

As theClinical SupportSpecialistyou willcoordinate and manage the care of late phase study patients ensuring close monitoring and protocol compliance for non-transitioned clinical trials. You will complete early and late phase serious adverse event (SAE) reporting and follow up documentation protocol amendment reconsents telephone triage query resolution deviationreportingand other tasks supporting the care of clinical trial patients.

• You will use study protocol as the primary tool to treat and follow patients

• You will assess patients and ensure adequate documentation including but not limited to oral medication forms dosing diaries protocol required questionnaires neuro exams vital signs sheets and timing of PK collection according to standard operating procedures

• You will accurately calculate and document the BSA creatinine clearance urine protein creatinine ratio and other conversions needed per protocol

• You will calculate and verify drug order and ensure physician sign off prior to initiating treatment

• You willidentifyneed for dose modification and adjust per protocol

• You will ensure that all medications including antiemetics are authorized prior to initiating treatment or when changing medication regimens such as crossover studies

• You willbe responsible forall data collection source documentation per protocol requirements

• You will prepare community clinics for upcoming visits if applicable

• You willbe responsible forongoing review of available patient records to ensure safety and protocol adherence

• You willassistwith patient reimbursement submissions

• You willassistwith telephone triage as needed

• You willassistwith coordinating hotel reservations and communications

• You willassistwith patient chart preparation with internal/external audits and inspections

• You will ensure that follow-up appointments scans or any related procedures are scheduled per protocol

• You will document and notifyappropriate SCRIcolleagues when patients come off study

• You will accurately complete data requests and queries within source documentation as outlined in applicable standard operating procedure.

• You willassistwith protocol deviationsinvestigateand report findings.

• You will reconsent patients and documentreconsentsper standard operating procedure

• You will notifyappropriate studyteam members and PI ofinitialand follow-up Serious Adverse Events as outlined in applicable standard operating procedure.

• You will complete protocol training as outlined inapplicablestandard operating procedure.

You should have for this position:

• AnAssociate DegreeBachelor Degreepreferred

• Current Registered Nurse (RN) license to Practice in the State of Tennessee

• At least one year of research experience and familiarity with Clinical Research Processes

• Medical and research terminology

• FDA Code of Federal Regulations and Good Clinical Practices

• Quickly adapt to the changing needs and requirements of the patient team protocol and work environment

• Tenacity self-motivation and initiative to drive the care of clinical research patients

• Work independently in a fast-paced environment with minimal supervision

• Oncology Nurse Certification (OCN) preferred

• Current Research Professional Certification (ACRPSoCRA) preferred