General DescriptionDepartment: Cardiology Monday-Friday 8:30a.m.-5:00p.m. 37.5 hrs.
Oversee the administrative and scientific implementation of research protocol for complex, multiple NIH sponsored research studies. As part of study team, collaborate with faculty, develop protocol, develop SOP, and oversee study-related activities for one or more studies. Emphasis on implementation of a protocol(s) in collaboration with PI and Research Nurses.
Duties and Responsibilities:
* Participate in development, testing and evaluation of manuals, questionnaires, and coding structures, for the efficient collection of data. * Participate as a member of collaborative group study team in study design, analysis of data, involved in discussions of next steps. * Oversee data collection at single site study or at multiple sites of a multi-centered clinical trial. * Analyze data; organize and quality controls raw data, use standard statistical techniques and/or package programs to run standard statistics. * Responsible for research procedures on study participants including measuring blood pressure, obtaining an ECG, phlebotomy, specimen processing and freezer management. * Ensures collection of pertinent data and maintains individual participant's binders from internal and external sources by maintaining a research chart for each research subject. Collects, enters and compiles clinical data from a variety of sources while ensuring accuracy and timeliness of data. * Verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements, obtains outside records when required. * Blood sample processing, including obtaining specimens by phlebotomy with appropriate handling and labeling. * Participate in writing manuscripts, abstracts for medical journals and meetings
* Participate in presenting projects/data at medical meetings * Participate in working on protocol development of sub-studies * Conduct training sessions and oversee day-to-day activities of lower level program coordinators and other staff working at other locations within multi-centered clinical trial and locally. * Work with study sponsors on study design and/or determine what group can commit to based on patient population, available resources and cost of providing services. * Participate in developing study budget. * Conduct literature searched to provide background information. * Abstract and index information based on knowledge of subject matter. * Perform self-audits and audits other sites. * Ability to travel between the East Baltimore Campus (Johns Hopkins Hospital) and other Hopkins locations (BVMC, Green Spring Station, etc.)
Duties prior to start of study: IRB application with consent form GCRC application. Training of GCRC personnel for study start. Contract/arrangements for study activities (e.g. EEG, EKG, labs) and all fee services. Recruitment in conjunction with study collaborators and study sponsors.
Once study begins: Scheduling of all patients in GCRC Online for all clinical research activities. Scheduling of all patients for all visits for all activities. Completion of all study forms. Data entry. Biologic sample mailing with patients for all study activities. Obtaining research meds from research pharmacy for study patients.