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Assists Study Directors/Principal Investigators with performing self-audits in preparation for external audits, as well as working with study teams to facilitate the conduct of external sponsor and regulatory agency audits and inspections.
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Ensure that the study, consent, and other documents provided to the subjects are approved by the IRB and comply with GCP and other regulatory requirements. Provide access to research-related records to monitors, auditors, representatives of the IRB, and regulatory authorities.
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The QAL will utilize audit and inspection intelligence and risk mitigation plans to assure adherence to Good Clinical Practice (GCP) in the conduct of clinical trials, the quality and integrity of generated data, and the rights and welfare of study participants.
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Education and Certifications: Associates or Bachelors degree in relevant field of study or equivalent work experience required CRCM preferred THIS POSITION MAY BE LOCATED IN ONE OF THE FOLLOWING LOCATIONS: JOHNSTON, RI; FORT WASHINGTON, PA; ISELIN, NJHours and Work Schedule: Hybrid - 3 days in-office / 2 remoteHours per Week: 40Work Schedule: Monday-Friday.
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The Clinical Research Coordinator is also responsible for keeping all data and source documentations, adverse event reporting, and IRB regulatory files. The Clinical Research Coordinator screens, enrolls and follows study participants, conducts data collection and entry, and performs noninvasive cardiovascular tests according to study protocols.
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The Nurse Clinician is a nurse who, through clinical experience, study and supervise practice in patient care at the masters or doctoral level, has gained expertise in a specific specialty area of patient care services.
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Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus. Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.
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Strong understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields. Bachelor Degree of Science in Biology, Microbiology, Chemistry, or similar field of study.
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They are accountable for execution of all applicable risk programs (Credit, Market, Financial Crimes, Operational, Regulatory Compliance), which includes effectively following and adhering to applicable Wells Fargo policies and procedures, appropriately fulfilling risk and compliance obligations, timely and effective escalation and remediation of issues, and making sound risk decisions.
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Job Description Key Responsibilities: Completes study-specific requirements for each assigned study which may include GCP training, IATA (dangerous goods) training, and study-specific training.
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MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, including clinical trial transparency,and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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Provides support in proper research protocol compliance and development, including regulatory controls, study procedures, and data management. Under direct supervision, performs a variety of tasks: assists in recruitment and screening of prospective research participants; obtains informed consent from study participants for minimal risk studies (as needed); collects, enters, and analyzes subject data; and compiles reports.
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Manages all regulatory issues, including protocol submissions, study record keeping, continuing approval, communication, and any other requirements specified by IRB. JOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Research Technician 3 supports data mining and machine learning studies to detect retinal conditions by focusing on research regulatory management, data collection, and coordination of all communication needs associated with a related research program.
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Track study metrics such as site start-up, Investigator/site performance, recruitment, regulatory documents, TMF filing and QC activities and elevate areas of concern to your supervisor.
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Assist with IRB submissions and regulatory materials related to medical records and study billing. Under the direction of the Principal Investigator or designee, the Clinical Study Coordinator II – Ophthalmology is responsible for coordinating clinical research projects and providing direction for other research staff.
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