Clinical Support Specialist RN

Mission

People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.

As the Clinical Support Specialist you will coordinate 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, deviation reporting and 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 initiatingtreatment

You will identify need 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 will be responsible for all data collection, source documentation per protocol requirements

You will prepare community clinics for upcoming visits, if applicable

You will be responsible for ongoing review of available patient records to ensure safety and protocol adherence

You will assist with patient reimbursement submissions

You will assist with telephone triage as needed

You will assist with coordinating hotel reservations and communications

You will assist with 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 notify appropriate SCRI colleagues when patients come off study

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

You will assist with protocol deviations, investigate and report findings.

You will reconsent patients and document reconsents per standard operating procedure

You will notify appropriate study team members and PI of initial and follow-up Serious Adverse Events as outlined in applicable standard operating procedure.

You will complete protocol training as outlined in applicable standard operating procedure.

You should have for this position :

An Associate Degree, Bachelor Degree preferred

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 (ACRP, SoCRA) preferred

As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered.