Research Program Coordinator

The Department of Medicine, Division of Gastroenterology is seeking a Research Program Coordinator (RPC) to be a member of the GI Clinical and Translational Research Unit (CTRU) and provide oversight and coordination of research projects managed by the CTRU. The RPC will be involved in human subject research sponsored by commercial sponsors, National Institutes of Health grants, donors, internal divisional funds, and other government and foundational funding sources.

This position will work with the principal investigators of the research projects assigned to the RPC, with direct oversight by the PI and GI CTRU manager. The RPC will also interact with the entire CTRU research team. The RPC will be responsible for various projects, working closely with investigators and staff. The position will set goals and timelines in collaboration with investigators and ensure timely accomplishment of project tasks and goals with high quality. The position is responsible for ensuring program quality, and adherence to expected processes and project goals and timelines. The position also organizes and ensures effective interaction with external partners, including the institutional review board (IRB), FDA, sponsors, outside research monitoring company or any other oversight group related to the research as needed.

Specific Duties & Responsibilities

• Screen medical records for eligible subjects
• Participate in participant recruitment efforts.
• Inform participants about study objectives and engage with participants regarding their understanding and concerns related to project.
• Obtain consent in-person or via telephone, maintain documentation of informed consent as appropriate, upload in electronic medical record and ensure suitable follow-up.
• Adhere to Johns Hopkins IRB, state and federal regulations related to human subject consent process and documentation
• Complete assessments and study tasks per protocol, including data acquisition, completion of study case report forms (CRFs) and data entry into study electronic database.
• Monitor research participants to ensure adherence to study rules.
• Adhere to research regulatory and ethical standards.
• Ensure that the necessary supplies and equipment for a study are in stock and in working order.
• Oversee overall research program implementation, data collection, timelines, goals and conduct of related tasks.
• Check data and reports for consistency, missingness, and accuracy
• Oversee detailed record management for research programs per FDA guidelines and assist with managing and performing data collection activities, which may include conducting telephone and in person interviews, administering questionnaires and follow-up lab results.
• Prepare, submit and track protocols, amendments, and related documents relevant to appropriate Institutional Review Boards, DSMB, and other oversight groups
• Ensure timely accomplishment of project tasks and goals with high quality
• File study documents appropriately according to best practice and Johns Hopkins, state, federal and IRB regulations
• When needed, assist with venipuncture and specimen collection according to patient safety standards. The specimen collection may involve different sites on campus or travel to pre-determined Johns Hopkins Gastroenterology satellite sites. If necessary, obtain training for drawing blood, specimen processing/handling and sending to lab by specific safety standards and guidelines.
• Work collaboratively with research team members, GI CTRU leadership, and project investigators and participate in research meetings.
• Assist with relevant financial reports, grant applications and reports relevant to the project(s)
• Provide oversight of budget expenditures and tracking of project funds together with the Principal Investigator, and Budget Analyst
• Support investigators in writing grant submissions, annual reports, abstract submissions, and other reports as required
• Coordinate yearly progress reports for funding organizations

Special Knowledge, Skills & Abilities

• Able to work independently and with multidisciplinary teams, interact with participants, be self-motivated, able to multi-task, prioritize, and problem solve.
  

• Adhere to guidelines regarding honest reporting of sensitive and confidential research and participant information.
• Understand the importance/impact of data integrity in terms of participants, study results, costs, quality of service and scientific research in general.
• Regular contact with researchers and collaborators requires the use of good judgment, tact and sensitivity.
• Excellent organizational and time management skills 
• Excellent interpersonal skills, both in-person and on telephone calls.<