Clinical Research Coordinator 248023Medix • Houston, TX, United States
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Clinical Research Coordinator 248023
Medix • Houston, TX, United States
[job_card.variable_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Performs study subject visits by, among other things; Screening and recruiting subjects; Dosing and administering study drugs and / or implementing study methodologies; Accounting for study drugs; Communicating with subjects and medical group providers, including the Principal Investigator and any Sub-Investigators; Collecting, labeling, storing, and shipping specimens collected from subjects in connection with a clinical research trial; Entering patient and research data in systems designated by the Company; and Maintaining patient charts and resolving research queries. Follows Good Clinical Practice Works cooperatively with others Monitors study activities to ensure compliance with study protocols and with applicable federal, state, and local regulatory and Site requirements and policies; Maintains required records of study activity including case report forms, drug dispensation records, and regulatory forms; Tracks enrollment status of subjects and documents dropout information, such as dropout causes and subject contact efforts and communicates this information as directed; Assesses eligibility of potential subjectsthrough methods such as screeninginterviews, reviews of medical records,and discussions with physicians and other healthcare professionals; Oversees subject enrollment to ensure that informed consentis properly obtainedand documented; Records adverse events and side effect data and confers with Investigators regarding the reporting of events to oversight agencies; Prepares for or participates in quality assurance audits conducted by study sponsors, federal agencies, or designated review groups; Creates source documents as assigned, such as regarding protocols, memos, patient participation; Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports; Reviews proposed study protocols to evaluate factorssuch as sample collection processes, data management plans,and potential subjectrisks; Instructs research staff in scientific and procedural aspectsof studies including standards of care, informed consentprocedures, or documentation procedures; Collaborateswith Investigators and Company Management to prepare presentations or reports of clinical studyprocedures, results, and conclusions; Communicateswith laboratories or investigators regarding laboratory findings; Reviews scientific literature, participates in continuing education activities, and / or attends conferences and seminars to maintain knowledge of clinical research; Orders drugs or devices necessary for study completion; Documents findings and events in the Company’s research CTMS platform and in other binders and platforms as directed; Occasional travel to Company sites, Investigator meetings, and / or Company meetings; and Performs other duties as assigned, including duties routinely performed by the Company’s Research Assistants.
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