The Division of Pediatrics Pulmonology is seeking a Clinical Research Specialist (CRS). The CRS will assist in the initiation, implementation, monitoring, reporting and completion of routine to moderately complex clinical research studies in the Division of Pediatric Pulmonology in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP). Develop solutions to complex problems that impact the timely and accurate conduct of clinical research.
Primary responsibilities include:
Participate in the evaluation of research protocols including study design and risk to target population. Assist in determining facility and equipment availability. Assess target population/availability.
Participate in protocol development and budget development as needed. Access and extract information for protocol development. Assist with composition and preparation of regulatory/IRB documents for new study submissions, amendments, continuing reviews and close-out. Develop worksheets for standard of care versus study specific procedures.
Schedule and/or coordinate study-related meetings, training sessions and pre-study site visits of sponsors. Develop advertising and other information materials for recruitment. Recruit subjects according to IRB-approved protocols. Schedule study visits, complete all necessary pre-visit tasks and execute study procedures according to protocols and clinical needs. Consent subjects and ensure that the Informed Consent Process is conducted appropriately and all forms are properly signed before the start of the study. Develop and implement teaching tools for subjects and families. Serve as advocate for the subjects and their family.
Order and receive drug/device supplies for studies and maintain appropriate inventory. Manage regulatory records for all medications and devices, including but not limited to logs for medication, dispensing logs, dates of expiration and refrigerator logs. Assist in preparation of drug orders. Oversee the proper handling of laboratory specimens including processes, shipping, storage, and documentation. Assist in assignment of drug and/or device supplies to research subjects.
Create source documentation tools. Extract data from source documents to complete Case Report Forms (CRF) and database entries. Collaborate with providers in the collection of clinical data. Audit for accuracy. Resolve sponsor queries to CRFs and regulatory documents.
Communicate with research subjects and hospital personnel to obtain follow-up information as needed. Review incoming subject adverse event (AE) information and assist PI in making submission and/determination of AEs. Capture and record adverse event data and compose reports for oversight agencies.
Conduct study-related and clinical-related assessments. Monitor for protocol compliance; document and report protocol deviations. Document patient responses to all interventions. Communicate with Principal Investigators regarding changes in protocols. Prepare and manage monitor visits. Maintain study documents as required by Regulatory guidelines. Maintain current knowledge of regulatory affairs and/or issues. Maintain a high level of expertise through familiarity of clinical literature and/or attending continuing education classes, conferences, seminars, and project team meetings.
Bachelor's degree in Science or a health-related field and one year of health-related or research experience; OR bachelor's degree in any other field or associate degree in Allied Health professions, and three years of health-related experience.
Knowledge of basic science and clinical trial research with human subjects. Ability to problem solve with a strong attention to detail. Excellent ability to effectively communicate and exchange information with a wide diversity of individuals. Superior organizational and project management skills, as well as basic math skills. Willingness to learn new techniques and skills as needed.
Pediatric research experience.
Salary Plan: TE
Salary Grade: 09
Job Function: Health Services
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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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