Under direct supervision the Principal Investigator (PI) supports all aspects of the NIH funded 8 center prospective Renal Anhydramnios Fetal Therapy (RAFT) trial. Enrollment in the trial is very time sensitive and therefore the coordinator’s hours need to be flexible according to new diagnosis and need for urgent consultations and procedures. 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, organizing collected information; records management, expenditure oversight, and communicating with team members of many different disciplines and at multiple institutions.
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 delivered at Johns Hopkins Hospital.
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).
Work closely with the DCC to coordinate site management.
Preparation, maintenance, and revision of IRB applications, while maintaining continual regulatory compliance.
Participate in weekly RAFT trial meeting with CCC and DCC.
Coordinate monthly local PI, Neonatology and potentially other subspecialty ZOOM meetings between the 8 sites.
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 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.
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, which may include scheduling, confirming appointments, and escorting/directing to various locations on/off campus.
Other duties as assigned.
Bachelor’s Degree in related field required.
Three (3) years of related experience required.
Additional education may substitute for required experience, to the extent permitted by the JHU equivalency formula.
JHU Equivalency Formula: 18 graduate degree credits (semester hours) may substitute for one year of experience.For jobs where equivalency is permitted, up to two years of non-related college course work may be applied towards the total minimum education/experience required for the respective job.
Clinical trial experience strongly preferred.
Classified title: Sr. Research Program Coordinator
Working title: Sr. Research Program Coordinator
Role/Level/Range: ACRP 37.5/E/03/MB
Starting Salary Range: $38,920.08 - $53,517.60 (commensurate with experience)
Employee group: Full time
Employee Status: Exempt
Schedule: Monday-Friday – 8am-4:30pm 37.5hrs/Wk
Location: Bloomberg 7S - 600 N. Wolfe St, Baltimore, MD
Department name: 10003189-SOM Sur Pediatric Surgery
Personnel area (School): SOM – School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
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The pre-employment physical for positions in clinical areas, laboratories, working with research subjects, or involving community contact requires documentation of immune status against Rubella (German measles), Rubeola (Measles), Mumps, Varicella (chickenpox), Hepatitis B and documentation of having received the Tdap (Tetanus, diphtheria, pertussis) vaccination. This may include documentation of having two (2) MMR vaccines; two (2) Varicella vaccines; or antibody status to these diseases from laboratory testing. Blood tests for immunities to these diseases are ordinarily included in the pre-employment physical exam except for those employees who provide results of blood tests or immunization documentation from their own health care providers. Any vaccinations required for these diseases will be given at no cost in our Occupational Health office.
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