John Hopkins University

We are seeking a Sr. Research Program Coordinator to oversee the administrative and scientific implementation of funded research, be responsible for the overall effective and efficient management of the program and program staff; regulatory and data management portfolio; clinical research and laboratory activities, including project management, financial accounting oversight for sponsored accounts, and grants and contracts management. This position will report directly to the Primary Investigator, Dr. Monica Mukherjee.

Specific Duties and Responsibilities

Programmatic Logistics

• Responsible for program logistics, including resource needs, oversight of adherence by staff to study protocols, guiding daily operations, and oversight of data collection. Provide oversight and guidance to administrative and research staff at JHU, and post-doctoral fellows and trainees with oversight from Dr. Mukherjee.
• Maintain regular and timely communication with the co-investigators and the regulatory oversight bodies (e.g., IRB, OSMB, DOD, and NIH) and will be responsible for all 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, as well as coordinating all protocol study procedures to be performed.
• 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 research program with other clinical research programs, regardless of their department association, to facilitate collaborative efforts and activities.
• Communicate regularly with Dr. Mukherjee and study collaborators to review the overall study progress.
• Coordinate and participate in meetings and other research activities with sponsors of clinical trials, as needed.
• Assist Dr. Mukherjee with staff/human resource activities tasks, 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.
• Supervise members of the research team with oversight from Dr. Mukherjee.

Research Implementation and Regulatory Oversight

• Complete necessary documentation in accordance with regulatory oversight bodies (e.g., IRB, OSMB, DOD, and NIH)
• Execute data use agreements between JHU and external collaborators with safe transfer and receipt of de-identified data elements.
• 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, and play a critical role in the conduct of the study.
• Responsible for the timely acquisition of the research data and samples and the maintenance of data integrity for the project and will be involved in the regular meetings for implementing, monitoring and evaluation of our project.
• 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 study sponsors (e.g. OSMB, DOD, NSF, and NIH).
• 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.
• Create and submit data use agreements with collaborators to ensure timely processing to facilitate research collaborations with other institutions (national and international) if applicable.
• 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.
• Independently prepare IRB applications and all the different forms necessary for submission to the institutional IRB.
• Oversee protocol approval processes and maintain regulatory compliance within the program. 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, on a timely manner with input from the PI. Update and compile applications, amendments, and annual reports. Update and compile IRB submissions and annual renewals. Prepare studies for internal and external audits and site monitoring visits. Write audit responses to the regulatory agencies with input from Dr. Mukherjee.
• Management of 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.
• Communication 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.

Clinical Research, Study Participant Recruitment and Management

• Responsible for primary data collection and management, study visit coordination, protocol implementation, quality control, and overall study organization.
• Oversee coordination of clinical research, including generation of databases, data management, and generation of regulatory submissions to the institutional regulatory bodies and governmental and foundational sponsors
• 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. Coordinate study schedules, collecting clinical data, treatment protocols, and follow-up appointments.
• 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.
• Responsible for research procedures on study participants including measuring blood pressure, obtaining an ECG, phlebotomy, specimen processing and freezer management; ensures collection of pertinent data and maintains individual participant’s binders from internal and external sources by maintaining a research chart for each research subject; collects, enters and compiles clinical data from a variety of sources while ensuring accuracy and timeliness of data; verifies patient eligibility for studies by comparing patient history and clinical laboratory results with protocol requirements, obtains outside records when required; and blood sample processing, including obtaining specimens by phlebotomy with appropriate handling and labeling.
• Serve as a database manager who is responsible for quality control, security, maintenance, and storage of clinical data in REDCap; 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.
• 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 if needed. 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
• 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. Participates in the preparation of summarized data for presentations in scientific forums and internal meetings, and for publications of technical and scientific reports.

Financial Management

• Responsible for budgetary management, assisting Dr. Mukherjee in the hiring of key personnel, 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.

Minimum Qualifications

• Bachelor's Degree in related discipline.
• Three years related experience.
• Additional education may substitute for required experience and additional related experience may substitute for required education beyond HS Diploma/Graduation Equivalent, to the extent permitted by the JHU equivalency formula.

Preferred Qualifications

• 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: $41,300 - $72,300 Annually ($56,800 targeted; Commensurate w/exp.)

Employee group: Full Time

Schedule: M-F 8:30am - 5:00pm

FLSA Status: Exempt

Location: Johns Hopkins Bayview

Department name: SOM DOM Cardiology

Personnel area: School of Medicine