Clinical Research Coordinator
CurrentAs a Clinical Research Coordinator in Lincoln Medical Center my role is to provide guidance on the administration of compliance, personnel, and other related aspects of clinical research studies being conducted. I must ensure that clinical research studies must be performed in accordance with federal regulations and research protocol. Review and comprehend study protocols, including timelines, inclusion and exclusion criteria, confidentiality, informed consent and privacy protections. Pre- screen and screen subjects for eligibility using protocol specific inclusion and exclusion criteria and educate them about the elements of informed consent. Collect documents needed to initiate a study and submit to a sponsor. Submit regulatory documents as required by protocol. Maintain adequate inventory of study supplies. Establish, organize, and monitor study files, such as regulatory binders, and study specific documentation. Prepare study materials such as informed consent documents, case report forms, enrollment logs and drug/device accountability logs. Provide appropriate training and tools for study team members. Maintain open lines of communication with local and central Institutional Review Boards, as well as study sponsors. Work with principal investigators, sub- investigators, and other study research staff daily to engage in problem solving, communication and protocol management. Promote ethical conduct of research.
