Assist in the conduct and implementation of clinical research in kidney diseases. Participate in the initiation, monitoring, completion, and reporting of routine to moderately complex clinical studies in accordance with Standard Operating Procedures (SOP) and Good Clinical Practices (GCP). Work closely with PI on research studies and follow the Standard Operating Procedures and Good Clinical Practices.
Primary Duties and Responsibilities:
- Assist in preparing for government-sponsored trials. Summarize literature review for study hypothesis.
- Participate in the evaluation of the protocol, study design and risk to subject population. Access and extract information for protocol development for medical library and online databases. Participate in protocol development or review of risk assessment for investigator-initiated trial. Assist in determination of staff availability and assessment of study population/availability. Determine facility/equipment availability.
- Compose and supervise preparation of regulatory documents including updates to Informed Consent forms. Compose case report forms for new studies in conjunction with the PI. Assist in developing advertisement and other information materials for recruitment.
- Identify and schedule screening procedures and review results. Ensure that the participant meets inclusion/exclusion criteria prior to participation in the study and randomization criteria prior to randomization. Ensure that Informed Consent forms are properly signed before the start of the study.
- Extract data from source documents. Compete Case Report Forms (CRF) or database entries. Assist in resolving sponsor queries. Review incoming subject adverse event (SAE) information and assist PI in making submission and/determination of SAEs. Capture and record adverse events data. Compose adverse event reports for oversight agencies. Compose and submit continuing review/amendments/close out information.
- Train support personnel on study-specific tasks.Train new staff in performance of study related procedures such as sleep monitoring, exercise monitoring, home, and ambulatory BP monitoring and activity monitoring. Monitor and ensure study team compliance with protocol and SOPs. Record, document, and report protocol deviations. Communicate with PI and sub-investigators about changes in the trial. Assist in completing paper work for new hires and maintain compliance with their research training requirements.
- Assist in the preparation for monitoring visits.
- Account for number of participants screened, found eligible, recruited, and if required randomized in the study. Maintain accurate records of those who did not meet these criteria to account for study flow. Assist is generating data-sets and extract relevant information regarding study end-points, adverse effects, serious adverse effects, and study-specified events of interest. Prepare summary reports for reporting to the data and safety monitoring boards. Generate slides for on-going monitoring of clinical studies on a biweekly basis or more frequently if required.
- 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 meeting.
- Perform other related duties incidental to the work described herein.
Bachelor's degree in science or a health-related field and one year of health-related/research experience; OR bachelor's degree in any other field/associate's degree in Allied Health professions and three years of health-related/research experience or two years of experience in clinical research.
Knowledge on procedures specified in the standard operating procedure and that the physician performs. Possess the ability to work effectively in teams and groups and to apply continuing quality improvement tools appropriately. Good organization and judgment skills, excellent communication skills.
Salary Plan: PAO
Salary Grade: 2RS
Job Function: Research
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