Sr. Research Program Coordinator

The Office of Capital Region Research (CAPRES) was created to facilitate and highlight the medical research element of the Johns Hopkins Medicine (JHM) tripartite mission in JHM hospitals in the National Capital corridor: Suburban Hospital, Sibley Memorial Hospital, and Howard County General Hospital. CAPRES mission is to create an environment for research activities within the three hospitals by providing local infrastructure, access to JHM resources, expert staff, and research subjects.

We are seeking a Sr. Research Program Coordinator who will work with multiple Principal Investigators (PIs) to perform the responsibilities inherent in clinical research studies. The Sr. Research Program Coordinator is a research professional working with and under the direction of the clinical PIs. While the PIs are primarily responsible for the overall design, conduct, and management of the clinical trial, the coordinator oversees, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study.

Specific Duties & Responsibilities

• Plans and coordinates the initiation of research study protocol, and the establishment of operating policies and procedures.

• Plans, implements, and maintains data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data.

• Recruits, instructs, and coordinates research subjects and/or volunteers, as appropriate to specific study objectives and work scope.

• Coordinates the day-to-day activities of any technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects.

            of research protocol, as required, in accordance with specified program objectives.

• Plans and coordinates the staffing of research studies, to include the recruitment and administration of research support staff, as appropriate to the activity.

• Supervises and coordinates the provision of support services to investigators and researchers.
• Monitors the progress of research activities; develops and maintains records of research activities, and prepares periodic and ad hoc reports, as required by investigators,

            administrators, funding agencies, and/or regulatory bodies.

• Maintain a database to track progress of CAPRES open protocols, accruals, and research proposals as well as any required CAPRES site database.

• Utilizes knowledge about policies and procedures at both institutions to assist researchers gain approval of protocols and move their protocols efficiently and quickly to completion. Support research teams in developing timelines of assigned tasks and facilitate better coordination among the administrative offices.
• Work closely with Office of Research Administration, Office of Human Subjects Protection, Office of Research Billing and the Technology Transfer Office at JHU and equivalent offices at the CAPRES site as appropriate.

• Utilizes comprehensive knowledge about Federal regulations (e.g.: FDA, OHRP, NIH) to guide investigators through the process.

• Maintains awareness of all of the offices/programs within CAPRES and JHM research administration including IRB that are available to assist research teams at both institutions.

• Liaison between PI's, co-investigators, research nurses, study coordinators and research offices at JHM and CAPRES site, and common sponsors such as the NIH and industry. Utilize a thorough knowledge of policies and procedures for approval and implementation of protocols to ensure work moves as quickly as possible through the system and to study completion.

• Assist and collaborate on complex clinical studies which require a high level of knowledge, coordination, and data extraction.
• Assist with preparing and maintaining all IRB and other regulatory documentation as required for multiple studies.
• Assist with IND submissions and tracking of IND records as required. It could also include work with outside auditors, corporate

            sponsors, or federal regulatory agencies like OHRP, the FDA, or NIH.

• Assists with preparation of clinical budgets for all projects. Operates with a high degree of independence in performance of functions.
• Participates in budget/contract review and negotiations as required.

• Implements quality control process throughout the conduct of the trial.
• Participates in clinical floor activities on an ongoing basis with research staff to ensure adequate clinical support for trial activities.

• Perform other job-related duties as assigned.

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