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Clinical Research Assistant

  • Anywhere

Company :
Unity Health Care Inc

Location :
Washington, District of Columbia

Expiry Date :
Fri, 05 Feb 2021 23:59:59 GMT

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Description :
The Clinical Research Assistant ensures that clinical trials and studies are run according to Unity Research Policy. The incumbent works with the ultimate goal of protecting patients participating in research studies. Research Assistants draw on their experience to promote good clinical practices and professional management of clinical studies. The Research Assistant in his/her designated specialty is responsible for promotion of good clinical practices and medical care in the conduct of clinical investigation.This will be performed by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of data generated at the site, and directing the conduct of the clinical investigation according to federal and state regulations and guidance documents. By the very nature of the profession, the level of assignment will call for a maximum degree of knowledge, professional judgment, and ingenuity. – ENSURES PROTOCOL COMPLIANCE: – Possesses a thorough understanding of the requirements of each approved protocol in the research portfolio under his/her direction. – Determines that inclusion/exclusion criteria are applicable to the study population. – Implements any protocol deviation or changes only with PI’s agreement. – Reviews the inclusion/exclusion criteria, schedule of visits, end point criteria, and investigational article use with the research team. – SUPERVISES RESEARCH STAFF: – Supervises the Research Associate. – MANAGES THE MEDICAL CARE OF SUBJECTS: – Ensures qualified personnel (PI or sub-investigator) is informed of all trial-related medical decisions. – Evaluates for adverse experiences. – Ensures that medical care is provided to a subject for any adverse event(s) under the direction of the PI. – Documents in the medical record the subject’s participation in the trial. – PROTECTS THE RIGHTS AND WELFARE OF SUBJECTS: – Reports all serious adverse events immediately to the PI. – Obtains a signed and dated informed consent from the subject or subject’s legal representative prior to initiating any study-related procedures. – ENSURES VALIDITY OF THE DATA REPORTED: – Ensures the accuracy, completeness, legibility, and timeliness of case report forms and source documents. – Ensures that case report forms accurately reflect source documents. – Explains any discrepancies between source documents and case report forms. KNOWLEDGE & EXPERIENCE REQUIRED BY THE POSITION – Ability to manage time effectively and organize own work. – Effective communication skills, both verbal and written. – An understanding of research processes and methodologies. – Good level of computer literacy. – Ability to record and check data to ensure accuracy QUALIFICATIONS – If already available, maintaining current license to practice nursing, physician’s assistant license, or nurse practitioner license. – Bachelor’s Degree preferred. – Ability to provide the PI with credentials as requested. – Disclosing conflicts of interest as described in the regulations. – 1 year of experience with the clinical aspects of research or the studied disease. – Strong data management and computer skills. – Experience working with research databases like Microsoft Excel. – Excellent verbal and written communication skills. EOE