Sr. Research Program Coordinator, Echocardiography

We are seeking a Sr. Research Program Coordinator, Echocardiography who will oversee research under the direction of the Principal Investigator, Dr. Monica Mukherjee, Director of the Echocardiography Lab and Associate Professor in the Division of Cardiology. The Sr. Research Program Coordinator will be responsible for the effective management of the research program and program staff to include clinical research and echocardiography laboratory activities, cardiac imaging project management, regulatory and data management portfolio, financial accounting oversight for sponsored accounts, grants and contracts management,

Specific Duties & Responsibilities

• Responsible for program logistics, including resource needs, oversight of adherence by staff to study protocols, guiding daily operations, and oversight of data collection.
• Responsible for hiring, orientation, training, and oversight and guidance of administrative and research staff at JHU, and post-doctoral fellows and trainees with oversight from Dr. Mukherjee.
• Ensure compliance with IRB and clinical protocols, facilitate and coordinate enrollment of prospective patients, ensure collection and integrity of clinical data, integrate the dataset into REDCap
• Assist Dr. Mukherjee in coordinating study schedules, collecting clinical data, treatment protocols, and follow-up appointments.
• Maintain communication with co-investigators and the regulatory oversight bodies (IRB, OSMB, and NIH)
• Engage in patient recruitment efforts ranging from patient identification and consenting processes in accordance with ICH and GCP guidelines and in conjunction with research staff at the Johns Hopkins Scleroderma Center and Pulmonary Hypertension Program, and coordinate protocol study procedures
• Responsible for the timely acquisition of research data and samples and the maintenance of data integrity for the project
• Attend regular meetings for implementing monitoring and evaluation of our project.
• Communicate regularly with Dr. Mukherjee and study collaborators to review the overall study progress.
• Execute data use agreements between JHU and external collaborators with safe transfer and receipt of de-identified data elements.
• Coordinate and participate in meetings and other research activities with sponsors of clinical trials, as needed.
• Establish timelines and monitor task completion of research projects.
• Coordinate schedules of MDs, technicians, and clinical lab staff to ensure that all study procedures and activities occur promptly.
• Coordinate the interactions of the cardiovascular ultrasound program with other clinical research programs, regardless of their department association, to facilitate collaborative efforts and activities.
• Oversee generation of databases, data management, and generation of regulatory submissions to the institutional regulatory bodies and governmental and foundational sponsors.
• Assist in the generation of data briefs, reports, academic papers, and presentations of key findings from assigned research projects. Present materials at workshops and conferences, as requested.
• Assist Dr. Mukherjee with staff/human resource activities, including performance reviews and timesheets.
  
• Responsible for assembling project plans, team, and work assignments, directing and monitoring work efforts daily.
• Facilitate communications among team members. Assure team productivity, develop and lead improvements in team functioning as required.
• Serve as a liaison between JHU and other participating sites to coordinate protocol implementation, study design, data management, data collection, and analysis.
• Coordinate all research activities for multi-center studies, preparing and compiling all reporting information needed for IRB, FDA, NIH, and study sponsors.
• Independently prepare IRB applications and forms necessary for submission to the institutional IRB. Oversee protocol approval processes and maintain regulatory compliance within the program.
  

• Create and maintain IRB applications and regulatory binders for each study.
• Assure IRB approval is current and appropriate human subject compliance training has been completed by key personnel. Update and compile IRB submissions and annual renewals.

• Create and submit Material Transfer Agreements with collaborators to the Technology Transfer Office and ensure timely processing to facilitate research collaborations with other institutions (national and international).
  
• In collaboration with Dr. Mukherjee, participate in the development of study design and clinical trial protocols, including literature search and review, budget design, application to funding agencies, industry collaborations, and IRB.
• Manage the progress of newly submitted and ongoing/pend