Clinical Protocol Coordinator

Position Requirements Overall Position Summary and Objectives Min Education Master's Resume Max Pages 3 Additional Qualifications Certifications & Licenses - PhD is required Field of Study - General Medical and Health Services Software - MS Office Skills - Experience in clinical trials and have experience working in an interdisciplinary environment such as a university hospital or research hospital like the NIH CC - 5-6 years professional experience with adults Due to the nature of the clinical trials performed by the LID, the contractor must be comfortable and have experience working with individuals with infectious diseases requiring isolation - Knowledge pertaining to privacy of the patient, privileged information and secure handling of the patient's medical records - Knowledge of Good Clinical Practice (GCP) Work Location

IC: NIAID

Street: 33 North Dr Bldg: NIHBC 33 - C.W. Bill Young Center Room: 3N16A City : Bethesda State & Zip : MD 208 92 Work Hours Weekly Hours FT: 30-40 hours per week # Of Hours 40 Statement of Work Details Assists researchers with protocol development, assembly and review of clinical trial documents. Provide advanced expertise in clinical trial coordination and implementation, data and protocol management. Assist with the implementation, tracking, data abstraction and collection, data reporting, and coordination of a variety of clinical trials in affiliation with the NIAID/DIR program Assists researchers develop and maintain trial related documents and operational procedures. Interview and screen participants for entry onto protocols Maintains study databases and conducts basic analysis. Assist with clinical protocols by assembling and training the study team Assists researchers collect, distribute and file regulatory documents. Coordinate the scheduling of participants Provides technical support to researchers and the clinic. Oversees compliance to protocol; developing and adhering to relevant SOPs Develops and assembles clinical trial documents. Provide quality-control, completion and submission of study related documentation Develops and maintains trial related documents and operational procedures. Prepare and assist with submitting and maintaining IRB, FDA, and/or other regulatory documents and research correspondence Collects and distributes regulatory documents. Develop study budgets and track budget expenses and billing for relevant services Develops, assembles and reviews clinical trial documents. Facilitate study enrolment through multiple mechanisms. Collects, distributes and files regulatory documents. Ensure participant compliance to study responsibilities through systematic notification Reviews and recommends changes to clinical trial documents. Prepare for and coordinate site visits made by sponsors or study monitors during the course of and at the close of the study Reviews and maintains trial related documents and operational procedures. Coordinate the collection, processing, shipment and storage of biospecimens Collects, distributes and submits regulatory documents. Monitor study enrolment goals and initiate strategies to promote enrolment. Develops training plans and trains staff on the proper techniques for protocol submission. Coordinate and perform responsibilities related to research participants including determining subject population availability, developing informed consents and screening materials, screening and recruiting subjects, scheduling visits, obtaining informed consent and overseeing study visits #J-18808-Ljbffr PriceSenz