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Actively recruits and screens eligible patients for research protocols. Assists and
conducts Informed Consent process. Completes Informed Consent quality
assurance assignments as needed.
Coordinates and implements enrollment and follow-up procedures to collect data
from patient charts, medical records, interviews, questionnaires, and other
sources. Cross-trains as backup on other studies as assigned. Creates protocol
worksheets and source document forms as needed.
Performs phlebotomy on both pediatric and/or adult patients and performs all
study lab processing including centrifuging, aliquoting, storage, freezer
maintenance and shipping as assigned. Obtain and reports research data.
Assures that study-related laboratory tests and diagnostic procedures are
completed, reviewed, and confirmed when necessary. Completes grading of labs
per DAIDS toxicity table and/or other study-specific grading scale.
Completes and submits Case Report Forms (CRFs) and pertinent study-related
forms accurately and within specified time limits. Resolves any logic checks,
errors, queries and delinquencies that come up with strict time-frames.
Completes quality assurance assignments. Communicates with providers,
protocol teams, sponsors, IRB, as well as others from the UF CARES staff
regarding the clinical management of signs, symptoms, toxicities, abnormal labs,
deviations, adverse events, etc.
Maintains contact with study patients to facilitate study retention and their care,
including communication regarding study requirements, coordinates drug
dispensing with Research Pharmacist, and other procedures, treatment, etc.
In-services UF CARES staff and other participating staff on research protocols
and topics.
Provides preceptorship and research trainings to new and current research
coordinators. This includes LDMS, Lab Processing of specimen, and study
related activities.
Updates study schemas/source documentation for studies and assists with
overall QA activities for the program.
Assists Research Manager with evaluating and providing support to Research
and other Supportive Administrative Staff.
Understands regulatory process and IRB and FDA requirements, ensuring
compliance with regulatory agencies. Assist with Regulatory submissions to IRB
and Sponsors. Assist with Study Monitors to ensure that all required security
access to Epic and establish a secure office for reviews.
Maintains monthly billing for study visits and documents appropriate fees on
research referral forms.
Attends pertinent educational or study activities to include some out of town
meeting and reviews current literature relevant to clinical area. Provides coverage
for Research Manager.
All other duties as assigned.
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