General Description Department: Oncology, Clinical Trials
Work Schedule/Hours: Monday-Friday/8:30-5:00pm/37.5 hours
Under the supervision of the Clinical Research Program Manager, the Sr. Research Program Coordinator is responsible for data management, regulatory activities, and research activities of patients entered onto NCI-sponsored protocols at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center (SKCCC). The Sr. Research Program Coordinator is primarily responsible for the organization, submission, maintenance and accuracy of all patient clinical research data in a timely and ongoing manner. This position involves complex clinical trials which will require independent work a high level of knowledge, coordination, and data abstraction. Responsibilities will also include assisting the research nurses in monitoring protocol compliance, preparing IRB submissions, and assisting with affiliate oversight. Duties and Responsibilities include:
Coordinate patient enrollment, data abstraction, case report form completion and submission, query resolution and responses, specimen shipping, and other protocol-related tasks. Adhere to all protocol requirements to ensure the validity of clinical research patient data.
Verify patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements.
Compile and maintain research charts for trial patients. Maintain patient registrations and relevant data points in SKCCC electronic patient databases.
In conjunction with clinical personnel, write and prepare serious adverse event reports and submit to the NCI through the AERS system.
Complete protocol activities for patients in follow-up, including ensuring appointments for follow-up visits, contacting patients to collect survival data and disease status, and administering quality of life questionnaires.
Maintain detailed working knowledge of all assigned protocols and be a resource for the principal investigators and nurses regarding protocol questions and sponsor requirements.
Review and assess new studies for difficulties that may arise with study processes and procedures. Suggest appropriate alternatives to possible complications.
Communicate regularly with principal investigators, research nurses and the Program Manager to review data accuracy and overall study progress.
May help design and create study-specific data collection forms.
May consent, enroll, and coordinate research activities for patients enrolled on non-therapeutic, laboratory or quality of life studies.
Prepare continuing reviews, protocol events, safety reports, and protocol amendments for submission to the JHM IRB through the eIRB electronic system.
Distribute protocol information and updates to the study team.
Submit, verify, and maintain protocol-specific information on the Cancer Center's Protocol Library and/or CRMS patient tracking system.
Maintain electronic regulatory binder for each assigned protocol.
Assist with affiliate oversight such as forwarding data-related queries, national updates and information, monitoring affiliate performance data for each network group, and providing support for questions from affiliate staff.
May assist the Program Manager with conducting affiliate audits.
Attain a high level of expertise in institutional databases including EPIC, EPR, CRMS, and eIRB.
Become highly knowledgeable concerning the structure and operations of the NCTN, ETCTN/ACP2C, the National Cancer Institute, and the relationship between these organizations and the Cancer Center and Johns Hopkins.
Maintain up-to-date knowledge of and comply with Good Clinical Practice, ICH Guidelines, and SKCCC Clinical Research Office policies. Demonstrate proficiency in research documentation standards.
Participate in all mandatory meetings to develop increasing knowledge of clinical trials. Complete minimum requirements for continuing education units.