General DescriptionUnder the limited supervision of the Clinical Research Program Manager , the Senior Research Program Coordinator II is responsible for coordinating the clinical course and research activities of the research program at Johns Hopkins. Position will oversee all facets of research activities, data management and regulatory activities for research projects. Responsible for monitoring progress of research protocols for institutional and multi-center studies; will work on several assigned research protocols simultaneously. Works on complex clinical studies, which require a high level of knowledge, coordination and data abstraction. Research protocols will vary in length, complexity, procedures required, number of subjects to enroll, investigator and site. Assist with orientation of less senior research staff in protocol and clinical research information.
DUTIES AND RESPONSIBILITIES
Consent and enroll patients into investigator-initiated and multi-site studies. Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements. Confirms patient registrations and relevant data points in databases for the SKCCC Clinical Research Office and Oncology Information Systems. Coordinate patient visits, collection of data, record maintenance, and regulatory documentation. Responsible for the collection and accuracy of data during each patient visit. Adheres to all protocol requirements to ensure the validity of clinical research subject data. Determine and report any abnormal symptoms of patient, including abnormal readings during procedures. Responsible for the organization, entry, maintenance, and accuracy of all patient clinical research data for complex and detailed studies. Maintains a research chart for each patient. Collects, enters and compiles clinical data from a variety of sources. Ensures accuracy and timeliness of data so that information may be used by the physician in treatment planning, presentations, and publication. Perform the following procedures for studies: collect and process samples (e.g., blood, urine, and tissue) and coordinate any procedures (i.e. x-rays, etc.) and others per protocols. Work with the research pharmacy with coordinating the dispensing of investigational drugs (if required). Maintains regulatory binder for each assigned protocol. Prepares and submits annual renewal requests, amendments, adverse event reports, etc., according to IRB and other institutional and sponsor requirements. May assist the principal investigator and/or program manager in defining information and plans required to accomplish goals of studies, including design of standard operating procedures. Will design and create protocol specific case report forms as needed. May also assist less experienced staff in design and creation of such forms. Meets regularly with study team to review data accuracy and overall study progress.
Participates in all mandatory meetings to develop increasing knowledge of assigned clinical trial and Registry requirements. Will develop and maintain a protocol database or spreadsheet for tracking patient activity, financial management and data analysis as needed. Will meet with clinical trial financial management staff to identify procedures, laboratory tests and protocol events that require invoicing to the research account/Sponsor as defined in the financial contract. May participate in the development of invoicing schedules. Prepares reports on individual patients or the study as required by the principal investigators and/or external agencies. Enters patient demographic and clinical data into institutional databases, as required. Responds in a timely manner to special projects or queries related to the data. Prepares for and participates in monitoring and audits of studies. Attend site visits throughout the course of the study with pharmaceutical representatives. On occasion, will prepare for and attend internal, sponsor, FDA, OSHA, OHRP or JCAHO inspections/audits. Assist in writing abstracts and manuscripts for different studies. Completes minimum requirement for continuing educational units. Is knowledgeable of and complies with Good Clinical Practices, ICH Guidelines and SKCCC Clinical Research Office policies.