Research Navigator, sIRB Navigator
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Aug 2, 2022
View more
- Position Type
- Administrative, Academic Affairs, Research Administration, Business & Administrative Affairs, Other Business & Administrative Affairs
- Employment Type
- Full Time
-
The Research Navigator, sIRB
Navigator will work with site investigators to help them
meet targets and milestones (ensure timely and accurate submission
to IRBs, sponsors and master agreements).
Execute project management processes and
methodologies to ensure projects are delivered on-time and within
the budget, adhere to high quality standards, and benefit the
investigative teams by ensuring smooth implementation of new trials
from conception through study activation.
Prepare regulatory documents for single
(sIRB) review for studies seeking sIRB coordination
resources.
Work with participating sites to compile
local context information for initial review, continuing review,
protocol event reports and applicable changes in research to
facilitate submission to the JHM sIRB.
Assist the JHM IRB in contacting
participating sites to address inquiries related to IRB
review.
Train participating site leads on sIRB
expectations/procedures.
-
Coordinate with JHM sIRB leads to enhance
sIRB processes for BIOS-supported
studies.
Develop work plans to achieve assigned
project goals and organize all activities in support of project
goals.
Complete and maintain professional
documentation for projects and
deliverables.
Obtain all required documents for new
grant and protocol submissions.
Track each protocol through the
IRB/subcommittee approval process, evaluate for recurrent problems,
develop and implement systems to decrease delays in the approval
process.
-
Draft consents.
Use professional judgment in handling
information based on the situation and be sensitive to individual
and organizational concerns.
Ensure smooth implementation of new
trials from conception through study
activation.
Work closely with the Studio Teams and
Cores to ensure all documents are complete prior to study/trial
activation.
Develop SOPs as
needed.
-
Collaborate with other
institutions.
-
Bachelor’s Degree with course work in
Science, Health Care Administration, or related field
required.
Minimum of five (5) years’ experience in
clinical trials/medical research comparable to overseeing the
administrative and scientific implementation of research
protocol(s) for complex and/or multiple research studies, and
delivering effective research project management
solutions.
Additional education may be substituted
for required experience, to the extent permitted by the JHU
equivalency formula.*
** Applicants who do not meet the posted requirements but are completing their final academic semester/quarter will be considered eligible for employment and may be asked to provide additional information confirming their academic completion date.
Preferred Qualifications:-
Master’s Degree
preferred.
Certification as a Clinical Research
Professional preferred.
-
Knowledge of FDA, ICH, and other
regulatory guidelines, experience in writing research materials,
excellent leadership skills, as well as excellent interpersonal and
communication skills are also required.
Experience with local and/or single IRB
policies and submissions.
Must be proficient in Microsoft Office
and possess the ability to learn new software programs such as
electronic data capture software, eIRB, and project management
software, which will be taught on the
job.
-
Ability to make independent judgments and
to act on decisions on a daily basis.
Ability to work for long periods of time
without direction.
Ability to prioritize own work and work
of others as needed.
Ability to work with flexibility on
several tasks simultaneously and to meet various concurrent
deadlines.
Very strong organizational skills,
analytical and problem solving abilities, and attention to
detail.
Demonstrated ability to coordinate
projects independently and work constructively as part of a
team.
Will oversee and coordinate the work of
teams in other institutions.
Ability to maintain
confidentiality.
Strong interpersonal and communication
skills, both oral and written.
Classified Title: Research
Navigator
Working Title: Research Navigator, sIRB Navigator
Role/Level/Range: ACRP/04/ME
Starting Salary Range: Commensurate with experience
Employee group: Full Time
Schedule: M-F 8:30 am - 5:00 pm
Exempt Status: Exempt
Location: School of Medicine Campus
Department name: SOM Neuro
BIOS
Personnel area: School of
Medicine
The successful candidate(s) for this position will be subject to a pre-employment background check.
The Johns Hopkins University values diversity, equity and inclusion and advances these through our key strategic framework, the JHU Roadmap on Diversity and Inclusion.
Equal Opportunity Employer
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
EEO is the
Law
Learn more:
https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf
Accommodation Information
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 Talent Acquisition Office at jhurecruitment@jhu.edu. For TTY users, call via Maryland Relay or dial 711. For more information about workplace accommodations or accessibility at Johns Hopkins University, please visit accessibility.jhu.edu.
Johns Hopkins has mandated COVID-19 and influenza vaccines, as applicable. Exceptions to the COVID and flu vaccine requirements may be provided to individuals for religious beliefs or medical reasons. Requests for an exception must be submitted to the JHU vaccination registry. For additional information, applicants for SOM positions should visit https://www.hopkinsmedicine.org/coronavirus/covid-19-vaccine/ and all other JHU applicants should visit https://covidinfo.jhu.edu/health-safety/covid-vaccination-information/.
The following additional provisions may apply, depending on campus. Your recruiter will advise accordingly.
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.
Note: Job Postings are updated daily and remain online until filled.
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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