Clinical Support Specialist

Sarah Cannon Research Institute•Nashville, TN

About The Position

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 initiating treatment. 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.

Requirements

An Associate Degree
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

Nice To Haves

Bachelor Degree preferred
Oncology Nurse Certification (OCN) preferred
Current Research Professional Certification (ACRP, SoCRA ) preferred

Responsibilities

Coordinate and manage the care of late phase study patients ensuring close monitoring and protocol compliance for non-transitioned clinical trials.
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.
Use study protocol as the primary tool to treat and follow patients.
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.
Accurately calculate and document the BSA, creatinine clearance, urine protein, creatinine ratio, and other conversions needed per protocol.
Calculate and verify drug order and ensure physician sign off prior to initiating treatment.
Identify need for dose modification and adjust per protocol.
Ensure that all medications, including antiemetics, are authorized prior to initiating treatment or when changing medication regimens, such as crossover studies.
Responsible for all data collection, source documentation per protocol requirements.
Prepare community clinics for upcoming visits, if applicable.
Responsible for ongoing review of available patient records to ensure safety and protocol adherence.
Assist with patient reimbursement submissions.
Assist with telephone triage as needed.
Assist with coordinating hotel reservations and communications.
Assist with patient chart preparation with internal/external audits and inspections.
Ensure that follow-up appointments, scans, or any related procedures are scheduled per protocol.
Document and notify appropriate SCRI colleagues when patients come off study.
Accurately complete data requests and queries within source documentation as outlined in applicable standard operating procedure.
Assist with protocol deviations, investigate and report findings.
Reconsent patients and document reconsents per standard operating procedure.
Notify appropriate study team members and PI of initial and follow-up Serious Adverse Events as outlined in applicable standard operating procedure.
Complete protocol training as outlined in applicable standard operating procedure.