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Job Title: IN-HOUSE CRA
Company: MedFocus
Location: Minneapolis, MN
Description:
IN-HOUSE CRA COMPANY INFO: NOW HIRING!! Are you looking to expand your career and enhance your professional skills? MedFocus is now seeking a In-house CRA to work in Minneapolis, MN. Our client makes it possible for millions of people to resume everyday activities, return to work, and live better, longer. RESPONSIBILITIES: The CRA will work closely with the CTL to satisfy applicable clinical and regulatory requirements and internal requirements for clinical studies. Focuses on assigned areas of clinical study management, and/or coordinates and conducts site monitoring (and oversight of CROs). Performs the following tasks with supervision: Contribute to the successful conduct of assigned studies consistent with Research, Development and Marketing plans. This may include interfacing with representatives from key functional groups including Field Clinical Engineering, Field Clinical Research Associates, Research, Biostatistics, Product Development, Manufacturing, Sales, Marketing, Distribution, Regulatory Affairs, and European Clinical Groups. Responsible for writing plans, strategy, and guidelines and performing activities and generating reports for one or more significant subparts of the study including: monitoring, data management, adverse events, consent, deaths, protocol deviations, legal agreements, study training, patient informed consent, newsletters/correspondence, publication committee, and contract research organizations. Assists in the development of the Clinical Investigational Plan, study budget and project schedule, study training materials, and study reports in consultation with the Clinical Trial Leader and cross-functional project team, and investigators. Assists Clinical Trial Leader in the development and/or delivery of study related presentations. Performs investigator and project file reviews for clinical study teams. Performs and/or provides oversight for CRF data review. Critically evaluates data for clinical reports, including collaboration with the study statistician to run appropriate error checks and evaluate final analyses. May participate in process improvement initiatives. May conduct electrical strip and/or episode review as needed. May review center activation documentation prior to CTL approval. Bachelor's degree in engineering, biological sciences or related medical/scientific field Knowledge of clinical research study processes and study design; ability to incorporate and adhere to Good Clinical Practices and regulatory standards Some experience supporting clinical research or similar experience in a medical/scientific area Professional clinical research certification (e.g., Association of Clinical Research Professionals, Society of Clinical Research Associates) preferred Proficient knowledge of medical terminology Proficient knowledge in word processing, spreadsheets, and database applications (e.g., MS Word and Excel) Knowledge of device operation and the ability to apply this knowledge to clinical study processes. KEYWORDS: Clinical, Clinical Trial Manager, Clinical Site Manager, Study Manager, Protocol, Clinical Research Associate, CRA, Biostatistician, Statistician, Data Manager, Coordinator, Statistical Programmer, SAS Programmer, CDISC, Biometrics, Statistics, Medical Writing, Regulatory, Scientist, Clinical Scientist, Dug Safety, Drug Safety Associate, Contracts Manager, Document Specialist, Clinical Support Specialist, Biostatistics, Monitor, Regional CRA, CRF, Case Report Form, Trial Master File, NDA, IND, Protocol, Investigator Brochure, ICH & GCP Guidelines, Pharmaceutical Company, Biotech, Biotechnology, Medical Device, CRO, Clinical Research Organization, Outsourcing, 1572, Tables, Listings and Graphs, TLGs, Director, Regulatory Affairs, Associate, Clinical Trial Associate, CTA, Oracle Clinical, ClinTrial, Physician, PhD, MD, Medical Monitor MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable. PUT YOUR INTEREST INTO ACTION AND CLICK APPLY NOW!!!!
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