title: Investigator responsibilities for clinical research studies: proper staffing can ensure an investigator is compliant.
abstract: The Code of Federal Regulations states that a clinical research investigator is responsible for conducting clinical research in compliance with the signed agreement, investigational plan, and U.S. Food and Drug Administration regulations. In order to meet all the research requirements, the proper research staff is critical. A dedicated, experienced clinical research coordinator is key. The research coordinator represents the investigator when interfacing with the corporate sponsor of the study and the practice staff to ensure that subjects are qualified and that the protocol is followed. Due to the wide range of responsibilities that a clinical research coordinator has, there are three skills that a quality research coordinator must possess: attention to detail, organizational and process understanding, and confidence.
authors.affiliation: BMK Consultants, 1611 Carroll Avenue, #1, Saint Paul, MN 55104, USA. ashley@bmkconsultants.com
authors.forename: Ashley Nichole
authors.initials: AN
authors.lastname: Kee
mesh_terms: D035843:Biomedical Research; D002986:Clinical Trials as Topic; D019983:Guideline Adherence; D006801:Humans; D012107:Research Design; D012108:Research Personnel; D012380:Role; D014481:United States