The School of Medicine seeks a Research Compliance Administrator who will work with faculty and staff within the Center for Innovative Diagnostics. This individual will be responsible for maintaining accurate and up-to-date regulatory files for a large portfolio of studies and sub-studies. S/he will work closely with US and international faculty, clinic coordinators, and regulatory specialists. This individual will be responsible for ensuring regulatory compliance and preparing IRB submissions using the Johns Hopkins IRB electronic application system.
Specific Duties and Responsibilities:
Collaborate with investigators, students, fellows, and staff located in the US and international locations, providing guidance and training in human subjects' research and regulatory requirements for new and ongoing research studies.
Assist investigators during protocol development, prior to submission to JHU and international IRBs, to ensure that regulatory and human subjects' requirements are met.Obtain all required US and international documents for new submissions to the Johns Hopkins IRB.
Work closely with the study sites to ensure all protocol amendments are accurately incorporated into protocol documents and consent forms.
Prepare applications to the JHU School of Medicine IRB for new studies, amendments to studies, annual reports adverse events, and protocol violations.
Prepare change in research submissions and MTA's for companies requesting biorepository samples or for pre-clinical pilot evaluations of new diagnostic devices or assays.
Assist students and fellows with IRB submissions, as needed.
Communicate with the IRB, addressing questions they have about study applications.
Track the status of a large number of studies, including approvals, study staff, study stage, progress, and grant support.
Participate in meetings and conference calls as needed and requested.
Maintain frequent and direct contact with research site investigators and staff; respond to questions and concerns as they arise.
Stay up-to-date on NIH, GCP, OHRP and federal regulations for human subject participation in clinical research.
Develop standard operating procedures as needed and update guidelines based on changing regulatory guidelines and regulations.
Compile bioethics and other IRB-related documentation for grant submissions and reports to funders.
Assist with compiling and formatting personnel documentation for grant submissions, as needed.
Complete administrative and scheduling tasks related to IRB and regulatory activities.
Perform other duties as needed.
This description is a general statement of required duties and responsibilities performed on a regular and continuous basis. It does not exclude other duties as assigned.
Minimum Qualifications (Mandatory):
Minimum of 3 years of experience in academic or industry-based clinical research required.
Additional education may substitute for some experience and some additional experience may substitute for some education, to the extent permitted by the JHU Equivalency Formula.
Special Knowledge, Skills and Abilities:
The candidate must have background and experience in research protection, federal and regulatory issues, research ethics, regulatory compliance, and use of centralized IRBs and master agreements.
General computer skills, with experience with Microsoft Office required.
Experience with Microsoft Access preferred.
Excellent verbal communication and interpersonal skills required. Individual must be a team player.
Outstanding organizational skills and attention to detail required.
This position requires a high degree of independent action and adherence to strict timelines.
JHU Equivalency Formula: 30 undergraduate degree credits (semester hours) or 18 graduate degree credits may substitute for one year of experience. Additional related experience may substitute for required education on the same basis. 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.
Classified Title: Research Compliance Administrator Role/Level/Range: ATP/04/PC Starting Salary Range: $50,700 - $69,780 annually (commensurate with experience) Employee group: Full Time Schedule: M-F 8-4:30pm Exempt Status: Exempt Location: 04-MD:School of Medicine Campus Department name: 60000453-SOM DOM ID STD Lab Personnel area: School of Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
If you are interested in applying for employment with The Johns Hopkins University and require special assistance or accommodation during any part of the pre-employment process, please contact the HR Business Services Office at email@example.com. For TTY users, call via Maryland Relay or dial 711.
The following additional provisions may apply depending on which campus you will work. Your recruiter will advise accordingly.
During the Influenza ("the flu") season, as a condition of employment, The Johns Hopkins Institutions require all employees who provide ongoing services to patients or work in patient care or clinical care areas to have an annual influenza vaccination or possess an approved medical or religious exception. Failure to meet this requirement may result in termination of employment.
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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