Research Navigator
- Employer
- Johns Hopkins University
- Location
- Maryland, United States
- Salary
- Salary Not Specified
- Date posted
- Nov 19, 2020
View more
- Position Type
- Administrative, Academic Affairs, Research Administration, Business & Administrative Affairs, Other Business & Administrative Affairs, Grants & Contracts
- Employment Type
- Full Time
General Summary/Purpose:
This is an exciting opportunity to serve as a Research Navigator for the Brain Injury Outcomes (BIOS) Division, which is also an NIH funded JHU Trials Innovation Center (TIC). BIOS (an academic research organization) incorporates the TIC, which is part of an initiative to create the Trial Innovation Network as part of the Clinical and Translational Science Award (CTSA) Program. In this position, there are opportunities to work with a high functioning, cutting edge team that will study, understand and improve multi-site translational research. This position requires a person with clinical trial design expertise and regulatory experience in working with IRBs and master/standard agreements. Autonomy, creativity, and critical thinking skills are strongly encouraged and definitely welcomed
Specific Duties & Responsibilities:
- The Research Navigator will work with site investigators to help them meet targets and milestones (ensure timely and accurate submission to IRBs, sponsors and master agreements).
- The Research Navigator will 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. Specific activities include
- 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/TIC-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 TICs
Minimum Qualifications (mandatory):
- Bachelor degree required.
- Minimum of five (5) years’ experience in delivering effective research project management solutions.
- 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.
Preferred Qualifications:
- Master’s degree preferred.
Classified Title:Research
Navigator
Working Title: Research
Navigator
Role/Level/Range: ACRP/04/ME
Starting Salary Range:$60,945-$83,865 (commensurate
with experience)
Employee group: Full Time
Schedule: Monday-Friday/8:30am-5:00pm
Exempt Status: Exempt
Location: 04-MD:School of Medicine Campus
Department name: 10003520-SOM Neuro BIOS
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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