MUST HAVE ONCOLOGY
Communication and Collaboration
- Acts as liaison between institutional investigators and pharmaceutical firms or their associates, national cooperative groups and institutional personnel.
- Maintains collaborative relationships with all research participants and research team members from all disciplines.
- Acts as a liaison for assigned service line leaders, investigators, nurses, pharmacists, pathologists, radiologists and other allied health care personnel.
Institutional Investigation Administration
- Assists institutional investigators with identification of potential research participants for the actively accruing clinical trials-prescreening.
- Serves as a resource during site visits/audits by the, FDA, NCI, Pharmaceutical firms, or other agencies designated by sponsors (especially as related to appropriate consent, proper record keeping and quality assurance).
- Prepares reports and statistical information for all assigned clinical research protocols as required by the Institutional Review Board and NCI.
Research Participant Coordination
- Checks eligibility requirements to determine research participant eligibility for assigned studies.
- Ascertains pretreatment and eligibility requirements of protocol have been met prior to registration.
- Registers all research participants according to sponsor requirements.
- Monitors through various forms of communication research participants for toxicities of protocol treatment.
- Documents research participant toxicities for clinic visits or phone interviews in compliance with applicable OCR SOP/SWP.
- Provides source documentation in the research participant's study chart as appropriate.
Research Study Coordination
- Creates protocol specific scheduling templates in scheduling in EPIC and schedules tests appropriately. Follows-up to ensure that all required tests, procedures or treatments were scheduled and completed as ordered.
- Prepares and submits reports of serious adverse events as required by the protocol, sponsor, IRB, FDA, NCI and OCR standard operating/work procedures in appropriate and timely fashion.
- Monitors dosage modifications and treatment calculations in conjunction with treating physician and Investigator.
- Assists Protocol Support Lab with arrangements for collection and shipping of samples as required by protocol.
- Provides Regulatory Coordinator with copies of protocol correspondence generated by sponsor for inclusion into the investigator study file.
Education and Training
- Discusses protocol participation with potential research participants and keeps them informed of procedures and changes in studies in which they are participating.
- Instructs participating physicians, nurses and clinical research associates in clinical research procedures, assure that data is submitted at appropriate levels and monitor their participation.
- Conducts and documents in-services for appropriate departments regarding study-related matters.