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Under direct supervision of the Principal Investigator (PI), we are seeking a Research Program Coordinator to support all aspects of the NIH-funded, 11 center prospective Renal Anhydramnios Fetal Therapy (RAFT) trial. Enrollment in the trial is time sensitive and therefore the coordinator’s hours need to be flexible according to new diagnoses and the need for urgent consultations and procedures. Therefore, this is a primarily in-person position. The Research Program Coordinator will be expected to coordinate IRB protocol changes in research, adverse event reporting, and new protocols. The range of duties includes but is not limited to patient recruitment/ interviews, data collection, Redcap data entry, organizing collected information; records management, expenditure oversight, performing administrative tasks; drafting calendar invites, agendas, meeting summaries and communicating with team members of many different disciplines and at multiple institutions.

The Research Program Coordinator will also work with the PI and the Division’s Senior Research Program Manager on the NIH-funded Chronic Kidney Disease in Children (CKiD) study. This multicenter, observational, prospective cohort of children, adolescents and young adults follows patients annually. Study visits include collection of bio-specimens, administration of data collection forms, neurocognitive measures, and coordination of ancillary procedures, including echocardiology. The Research Program Coordinator will be responsible for patient recruitment and retention, conduct of study visits, and coordination with both the central and local Institutional Review Boards for CKiD.

Specific Duties & Responsibilities

• Oversee patient recruitment, screening for eligibility, and enrollment of eligible subjects for participation in RAFT trial. Explain the protocol in detail to potential patients, referring providers and participating providers.

• Enter data into Secure Redcap database for RAFT patients screened and delivered at Johns Hopkins Hospital. Screening and delivery data must be entered into REDCap within 24 hours of the coordinator being notified of these events.

• Be the lead coordinator for the Clinical Coordinating Center (CCC) of the RAFT trial and facilitate all communication to the RAFT Data Coordinating Center (DCC).

• Organize weekly CCC/DCC calls including creating and circulating agendas prior to all meetings. Keep and circulate minutes.

• Work closely with the DCC to coordinate site management.

• Preparation, maintenance, and revision of IRB applications, while maintaining continual regulatory compliance.

• Preparation, maintenance, and revision of MOP in coordination with the DCC

• Participate in weekly RAFT trial meeting with CCC and DCC.

• Coordinate monthly local PI, Neonatology, Nephrology, Multi-disciplinary and potentially other subspecialty ZOOM meetings between the 11 sites.

• Coordinate quarterly meetings with RAFT Executive Committee, communicating with PI on developing the agenda and following up with action items

• Processing of patient samples and coordination with sending samples to biobank at All Children’s Hospital.

• Collaborate with North American Pediatric Renal Trial and Collaborative Studies (NAPRTCS) administration and centers where surviving infants received long-term dialysis care to ensure capture of all required long-term patient data including PedsQL surveys and transfer of data to DCC.

• Work closely with the lead PI to maintain study expenditure tracking and reporting milestones for financial invoicing.

• Act as a liaison for various studies with sponsors, study monitors, patients and their care providers; assist various monitors during study monitor visits and audits.

• Draft reports on study progress for the NIH.

• Organize and participate in Data Safety Monitoring Board meetings to keep and circulate minutes

• Help maintain the RAFT website and clinicaltrials.gov

• Attend biannual conference for the North American Fetal Therapy Network to coordinate meetings between lead and local PIs at dedicated sessions.

• Participate in grant preparation to supplement study funds.

• Act as primary contact for JHH study participants or potential participants, which may include scheduling, confirming appointments, and escorting/directing to various locations on/off campus. When potential participants contact the Johns Hopkins for information, coordinator will respond (after discussion with study PIs) on the same business day, or no more than 24 hours after initial contact.

• Organize scientific manuscript circulation and submission for RAFT associated studies

• Other duties as assigned.

Minimum Qualifications

• Bachelor’s Degree in related field required.

• Some related experience required.

• Additional education may substitute for experience, and additional experience may substitute for education, to the extent permitted by the JHU Equivalency Formula.

Preferred Qualifications

• Clinical trial experience preferred.

Special Knowledge, Skills, & Abilities

• Excellent computer skills and organizational skills a must as well as attention to detail.

• Knowledge of software, including Microsoft Word and Excel is needed.

• Requires outstanding verbal communication and interpersonal skills with participants, Principal Investigators, and other team members. Interest in working with mentally ill/disadvantaged populations needed.

• Must be highly motivated, organized, personable, willing to learn, responsible, reliable, and efficient.

• Must be comfortable working with patient populations.

Classified Title: Research Program Coordinator

Role/Level/Range: ACRO40/E/03/CD

Starting Salary Range: $17.00 - $30.00 HRLY ($47,000 targeted; Commensurate with experience)

Employee group: Full Time

Schedule: M-F; 8:30 - 5:00

Exempt Status: Non-Exempt

Location: Hybrid/School of Medicine Campus

Department name: ​​​​​​​SOM Ped Nephrology

Personnel area: School of Medicine

Equal Opportunity Employer:

Johns Hopkins University is an equal opportunity employer and does not discriminate on the basis of race, color, gender, religion, age, sexual orientation, national or ethnic origin, disability, marital status, veteran status, or any other occupationally irrelevant criteria. The university promotes affirmative action for minorities, women, disabled persons, and veterans.