Research Compliance Administrator
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Jun 21, 2021
View more
- Position Type
- Administrative, Academic Affairs, Research Administration
- Employment Type
- Full Time
-
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.
Minimum Qualifications (Mandatory):
-
Bachelor’s
degree.
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.
- 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 atjhurecruitment@jhu.edu. 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.
Equal Opportunity
Employer
Note: Job Postings are updated daily and remain online until
filled.
EEO is the
Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf
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 jhurecruitment@jhu.edu. 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.
Equal Opportunity Employer
Note: Job Postings are updated daily and remain online until filled.
EEO is the Law
Learn more:
https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdf
Important legal information
http://hrnt.jhu.edu/legal.cfm
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