- 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 subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and other health care professionals;
- Oversees subject enrollment to ensure that informed consent is properly obtained and 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, and patient participation;
- Prepares study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports;
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks;
- Instructs research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures;
- Collaborates with Investigators and Company Management to prepare presentations or reports of clinical study procedures, results, and conclusions;
- Communicates with 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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University of Central Florida Kennedy Space Center, United StatesUnleash Your Potential With UsAs a next-generation public research institution, we are an inclusive community of thinkers, doers, creators, innovators, healers, and leaders striving to shape the future and solve the world's most challenging problems. No matter what your role is, ...
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