The clinical research nurse will coordinate and implement pediatric diabetes clinical research under the direction of the clinical research nurse manager and principal investigator in accordance with good clinical practice and institutional standard operating procedure. Participate in initiation, recruiting, documentation, monitoring, completing and reporting of routine to moderately complex clinical studies.
Primary Responsibilities Include:
Recruit participants according to IRB approved methodologies. Using acceptable procedures, review records, identify and screen potential participants to ensure they meet the study criteria. Monitor enrollment goals and modify recruitment strategies as necessary.
Ensure appropriate informed consent processes are followed: including discussions of treatment and intervention alternatives, voluntary nature of the study, ongoing opportunity for questions and discussions, understanding of participant, assent when appropriate, and proper documentation of process.
Coordination of visits, Schedule participant visits with support services, perform interviews and clinical assessment to collect data required by the protocol. Complete source documents, case report forms, and other paperwork for study visits. Evaluate patient status for safety and ensure optimum health care.
Attend and participate in investigator meetings and calls with the sponsors. Review and assess progress and conduct of study design and implementation.
Maintain study files, provide copies of forms to study sponsor, IRB, general clinical research center, FDA etc. including reporting of SAEs, AEs per regulatory and institutional guidelines. Act as a liaison between research staff, study sponsor, IRB, federal state and University officials and other regulatory agencies.
Order and receive drug/device supplies. Dispense drug (calculate dosage as needed), supplies, and devices according to sponsor directions and institutional procedures. Provide clear instructions to the participants &/or their families.
Ensure proper collection, documentation, processing and shipment of specimens.
Oversee proper documentation of close-out as required by grant sponsors including return of unused supplies, reconciliation of test/drug accountability forms, study summary, evaluation of team effort and subject enrollment. Prepare and respond to sponsor or FDA audits.
Expand knowledge base and remain abreast of new research developments by attending continuing education meetings, lectures, training and conferences.
Bachelor's degree in nursing and one year of experience in clinical nursing; OR Associate of Science degree in nursing (ASN) and three years of experience in clinical nursing; OR LPN/diploma in nursing and four years of experience in clinical nursing.
Ability to effectively communicate and exchange information.
Salary Plan: PAE
Salary Grade: HE
Job Function: Health Services
Due to the COVID-19 pandemic, there may be differences in the working conditions as advertised in our standard job postings (e.g., the ability to travel from one campus to another, etc.). If you are invited for an interview, please discuss your questions or concerns regarding the working conditions at that time.
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.
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