McKesson
Clinical Support Specialist
USA, TN, Nashville
Sponsorship not specifiedDetected 5 days ago
Clinical TrialsClinical ResearchFDA RegulatoryResearchCommunication
About the role
- Our people are the foundation of our success.
- Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world.
- Focused on advancing therapies for patients over the last three decades, SCRI is a leader in drug development.
Responsibilities
- Tenacity, self-motivation, and initiative to drive the care of clinical research patients
Requirements
- An Associate Degree, Bachelor Degree preferred
Compensation
- As part of Total Rewards, we are proud to offer a competitive compensation package.
Benefits
- Medical and research terminology
Company info
- 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.
- As the Clinical Support Specialist, you will c oordinate 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.
- You should have for this position:
- 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
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