Planning and implementation of a clinical trial to include but not limited to coordination with all members/ departments/ external institutions of the study team, oversight of IRB, regulatory and /or FDA submissions, budget preparation participation, and study management tool development Provide education and training to other health care professionals related to patient participation in a clinical trial.
Ongoing oversight of several projects' IRB and Regulatory management.
Screening, recruitment, and enrollment of study participants. Procure eligibility data and materials, interface with sponsors as appropriate in determining eligibility.
Collaborates with the PI in the case management of protocol patients; assuring compliance with the protocol and regulatory requirements and patient billing compliance
Oversee study lab specimen collection, processing and shipping
Collecting, recording and maintaining accurate data.
Oversee coordination of long term data collection
Prepare and participate in Cooperative Group Audits, NCI, FDA, Sponsor GCP quality audits, Loyola internal audits and department audits.
Participation in program research planning to include as appropriate, protocol development, data reporting and grant reporting.
Participate in Departmental Process Improvement Activities, National Committees as appropriate
Establish thorough knowledge base of assigned trials in order to coordinate the care of the protocol patients through the medical center encounters
Nursing assessment skills
Patient and family education related to the trial
Triage of calls from assigned protocol patients
Provides timely feedback to principal investigators and local physician caring for patient
Monitoring of patients as defined by protocol
Provide timely information to all regulatory bodies as required by protocol with particular attention to patient toxicities.
Establish and maintain effective collaborative communications with Cancer Center Care Team as well as other multidisciplinary bodies on campus
Project management of multiple projects with varied critical time demands