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/pending contracts, budgets, and grants, and coordinate communication between PI, CRO, IRB, NIH, and sponsors.
  
• Respond to requests for information from the foundation, DoD, NIH, IRB, in a timely manner with input from the PI.
• Update and compile applications, amendments, and annual reports.  Prepare studies for internal and external audits and site monitoring visits. Write audit responses to the regulatory agencies with input from Dr. Mukherjee.
• Responsible for primary data collection and management, study visit coordination, protocol implementation, quality control, and overall study organization.
• Monitor the collection of research data on subjects entered into the research database. Ensure specified clinical, serologic, laboratory, pulmonary function test, echocardiogram, and hemodynamic data are collected on all patients.
• Obtain informed consent for prospective patient recruitment, as needed, with input from the PI.
• Interface with co-investigators and research staff for prospective patient recruitment, enrollment and coordination of testing, appropriate storage and maintenance of serum and biological materials, ordering and follow-up of necessary testing.
• Serve as a database manager responsible for quality control, security, maintenance, and storage of clinical data in REDCap; data harmonization efforts in Precision Medicine Analytics Platform (PMAP); and queries performed in the PMAP SQL computing environment.
• Responsible for monitoring the progress of research protocols for single institutions and multicenter studies and collecting data on patients entered research protocols.
• Collect, review for adherence to regulations, and track all regulatory documentation for sites involved in clinical trials.
• Responsible for quality control of all imaging data acquisition, analysis, and acquired data points.
• Work with physician investigators to assist in designing protocols for cardiovascular imaging utilization in various research projects.
• Directly responsible for assessing new techniques for Echo/Doppler evaluations of the cardiovascular system as applied for research.
• Interface with device companies and the pharmaceutical industry in the evaluation of new medical imaging equipment and imaging contrast agents for specific research projects at JHU.
• Develop, design, program, organize, and maintain all database systems for each project to store key information related to image and analysis for each protocol.
  
• Train all team members in the use of database system and help troubleshoot.
• Responsible for quality control of each database.
• Generate queries and reports needed for project management, reporting, analyses, and manuscript publication; as well as abstracting data from source documents; input, organize and edit data.
• Prepare/maintain research subject charts, prepare study timelines. Generate reports pertaining to demographics, trends, and longitudinal analysis of study subject data, as required by Dr. Mukherjee, and/or external agencies.
• Responsible for budgetary management, overseeing the hiring of staff, contract procurement, and software purchase in conjunction with divisional, departmental, and university representatives with oversight from Dr. Mukherjee.
• Work directly with Grant Administration and Office of Research Management to plan and conduct analysis of financial reports and data to maintain business activities related to Dr. Mukherjee's projects.
• Assist Dr. Mukherjee in the review and reconciliation of expenditure statements for sponsored Research Programs, general funds, gift and discretionary accounts.
• Develop and negotiate budgets for sponsored projects in collaboration with the Dr. Mukherjee.
• Develop projections, and reporting for active and pending sponsored projects. Recommend budget adjustments and payroll effort reporting to align with project activities and goals.
• Monitor project budgets, allocation of project resources, and approve expenditures on all sponsored projects related to Dr. Mukherjee throughout each fiscal year in conjunction with divisional, departmental, and university representatives.
• Manage PI portfolio of active, pending, and completed sponsored projects.
• Prepare documents for pre-and post-award submissions that include, but may not be limited to proposal preparation, budget development, account maintenance, and oversite.
• Ensure timely, effective, and efficient functioning of sponsored projects. Partner with department faculty and/or financial department staff and the Office of Research Administration toward the planning and development of application submissions to various federal offices, private agencies/foundations, and commercial companies.
• Communicate with funding agencies and/or private companies in order to confirm or clarify grant/contract submission requirements. Assist Dr. Mukherjee in completion of required information. Provide information and direct assistance required to complete contract and grant submissions and closeouts.

Additional Knowledge, Skills, & Abilities

• Familiarity with cardiac MRI and CT.
  
• Knowledge of digital acquisition and data analysis.
• Knowledge of spreadsheet and word processing.

• Bachelor's Degree in related discipline.
• Three years related experience.
• Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.

• Master's Degree strongly preferred.
• Clinical research experience, including IRB application and maintenance process.

Classified Title: Sr. Research Program Coordinator   
Role/Level/Range: ACRP/03/MB  
Starting Salary Range: $40,900 - $71,600 Annually ($56,250 targeted; Commensurate with experience) 
Employee group: Full Time 
Schedule: M-F 8:30am - 5:00pm 
Exempt Status: Exempt 
Location: Johns Hopkins Bayview 
Department name: SOM DOM Cardiology  
Personnel area: School of Medicine