General DescriptionDepartment: Gastroenterology 20 hrs. per week
Under the direct supervision of the Principal Investigator, the Research Program Coordinator is responsible for the collection, organization, entry, maintenance and accuracy of clinical research data for clinical studies. The Research Program Coordinator will collaborate in development & writing of consent forms, in development and preparation of regulatory documents as appropriate and clarifying concerns & questions about new protocols with PI and/or sponsor.
Duties and Responsibilities:
* Determine patient study eligibility, obtain informed consent, and initiate patient randomization and enrollment. * Maintains good working knowledge of all assigned protocols and reporting requirements. * Follows HIPAA and IRB guidelines. * Maintains regulatory binders for assigned protocols. * Prepares and submits annual renewal requests, amendments and adverse event reports with clinical input according to IRB and Sponsor requirements. Adheres to all protocol requirements to ensure the validity of the clinical research data. * Designs and creates protocol specific case report forms as needed * Prepares, organizes and participates in all audits of study procedures. * Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and Departmental Research Office policies. * Ensures accuracy and timeliness of data collection so that information may be used by the PI in planning for grant writings, presentations and publication. * Meets with PI to review data accuracy and overall study progress. * Participates in design of upcoming studies as well as the preliminary and intern analyses of data, performs statistical calculations and assists with preparation of reports, scientific abstract and manuscripts related to projects
* Participates in all mandatory meetings to develop increasing knowledge of assigned research and clinical trials * Attends educational lectures and conferences. * Designs study database (ACCESS format) and develops quality control procedures to ensure accurate and timely data input. Creation of scanned case report forms and maintenance of database system. * Develops and monitors overall progress of study in relation to study goals * Collects, enters and compiles clinical data from a variety of sources. * Gathers and documents into EPIC essential and accurate information about participant's medical and medication history, patient reported outcomes, disease activity indices and laboratory and clinical data, after an appropriate period of training. * Maintains efficiency of clinic and research flow amongst multiple physicians * Identify and resolve errors or issues associated with the research study * Collects blood samples from research participants. * Prepares and stores specimens according to institution and federal guidelines. * Performs other duties as required