Clinical Support Specialist

Customer SupportCustomer SupportFull TimeRemoteMid LevelTeam 10,001+Since 1833H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

1 day ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

Clinical Support Specialist

McKesson

Role Description 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. Your responsibilities include: - Completing early and late phase serious adverse event (SAE) reporting and follow-up documentation. - Managing protocol amendment reconsents, telephone triage, query resolution, deviation reporting, and other tasks supporting the care of clinical trial patients. - Using study protocol as the primary tool to treat and follow patients. - Assessing patients and ensuring adequate documentation, including but not limited to: - Oral medication forms - Dosing diaries - Protocol required questionnaires - Neuro exams - Vital signs sheets - Timing of PK collection according to standard operating procedures - Accurately calculating and documenting the BSA, creatinine clearance, urine protein, creatinine ratio, and other conversions needed per protocol. - Calculating and verifying drug orders and ensuring physician sign-off prior to initiating treatment. - Identifying the need for dose modification and adjusting per protocol. - Ensuring that all medications, including antiemetics, are authorized prior to initiating treatment or when changing medication regimens, such as crossover studies. - Being responsible for all data collection and source documentation per protocol requirements. - Preparing community clinics for upcoming visits, if applicable. - Ongoing review of available patient records to ensure safety and protocol adherence. - Assisting with patient reimbursement submissions. - Assisting with telephone triage as needed. - Coordinating hotel reservations and communications. - Preparing patient charts for internal/external audits and inspections. - Ensuring that follow-up appointments, scans, or any related procedures are scheduled per protocol. - Documenting and notifying appropriate SCRI colleagues when patients come off study. - Accurately completing data requests and queries within source documentation as outlined in applicable standard operating procedures. - Assisting with protocol deviations, investigating and reporting findings. - Reconsenting patients and documenting reconsents per standard operating procedure. - Notifying appropriate study team members and PI of initial and follow-up Serious Adverse Events as outlined in applicable standard operating procedures. - Completing protocol training as outlined in applicable standard operating procedures. Qualifications - 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. Benefits We care about the well-being of the patients and communities we serve, and that starts with caring for our people. Our Total Rewards package includes comprehensive benefits to support physical, mental, and financial well-being: - Competitive compensation package determined by performance, experience, skills, equity, regular job market evaluations, and geographical markets. - Annual bonus or long-term incentive opportunities may be offered.

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