first_img Twitter You need to sign in or create an account to save Maryland, United States You need to sign in or create an account to save Johns Hopkins University Apply(This will open in a new window from which you will be automatically redirected to an external site after 5 seconds) Share The successful candidate(s) for this position will be subject to apre-employment background check.If you are interested in applying for employment with The JohnsHopkins University and require special assistance or accommodationduring any part of the pre-employment process, please contact theHR Business Services Office at [email protected] For TTYusers, call via Maryland Relay or dial 711.The following additional provisions may apply depending on whichcampus you will work. Your recruiter will adviseaccordingly.During the Influenza (“the flu”) season, as a condition ofemployment, The Johns Hopkins Institutions require all employeeswho provide ongoing services to patients or work in patient care orclinical care areas to have an annual influenza vaccination orpossess an approved medical or religious exception. Failure to meetthis requirement may result in termination of employment.The pre-employment physical for positions in clinical areas,laboratories, working with research subjects, or involvingcommunity contact requires documentation of immune status againstRubella (German measles), Rubeola (Measles), Mumps, Varicella(chickenpox), Hepatitis B and documentation of having received theTdap (Tetanus, diphtheria, pertussis) vaccination. This may includedocumentation of having two (2) MMR vaccines; two (2) Varicellavaccines; or antibody status to these diseases from laboratorytesting. Blood tests for immunities to these diseases areordinarily included in the pre-employment physical exam except forthose employees who provide results of blood tests or immunizationdocumentation from their own health care providers. Anyvaccinations required for these diseases will be given at no costin our Occupational Health office.Equal Opportunity EmployerNote: Job Postings are updated daily and remain online untilfilled.EEO is the LawLearn more:https://www1.eeoc.gov/employers/upload/eeoc_self_print_poster.pdfImportant legal informationhttp://hrnt.jhu.edu/legal.cfm LinkedIn Salary Not Specified Save Assessment & Evaluation Analyst Johns Hopkins University Research Data Analyst Save Research Technologist Salary Not Specified Research Technologist More searches like this Assessment & Evaluation Analyst Maryland, United States TheDepartment of Radiation Oncology is seeking a regulatory specialistthat will serve as a central resource for regulatory aspects offaculty conducting clinical research. Working closely with theProgram Manager, Research Nurses, Grants and Contracts staff, PIsand sponsors, this position will complete and submit the initialIRB submission for both prospective and retrospective protocols.Prior to the start of a study, will ensure all proper regulatorydocuments have been approved and that all documents, Case ReportForms, databases, monitoring/auditing requirements have beencompleted. Will produce and maintain an electronic regulatorybinder prior to the study initiation with all required documentsand additional sections for future documents. Will work closelywith the study coordinators to ensure all documents are submittedto the IRB in a timely manner. Keep up to date on new School ofMedicine and SKCCC regulatory guidelines and SOPs and advise theclinical trial team on theserequirements.SpecificDuties/Responsibilities:Workclosely with the Research Nurses and PI on new studies to ensuretimely, accurate submission to the IRB andsponsors.Assure protocols have complete, consistent language throughout,including proper SAE reporting requirements, SKCCC requirements,etc.Obtain all required documents for new submissions to theIRB.Trackeach protocol through the IRB/subcommittee approval process,evaluate for recurrent problems, develop and implement systems todecrease delay in the approvalprocess.Prepare reports and present updates on protocol submissionprocess.Complete new study IRBsubmissions.Ensure smooth implementation of regulatory aspects of new trialsfrom conception through studyactivation.Workclosely with the Protocol compliance team to ensure all documentsare ready prior to a studyopening.ForIND/IDE studies, maintain accurate and up-to-date documents andsubmissions.Coordinate and attend Clinical Trial Review Committeemeetings.Initiate all clinical trials in the CT.gov system and work withthe PI and Program Manager to maintain studyinformation.Produce and maintain a regulatory binder prior to study startingwith all requireddocuments.Workclosely with sponsors to ensure all documents are reviewed,approved and correct prior to a studyopening.Ensure that all continuing reviews are completed and submittedto the IRB in a timelymanner.Actas the lead resource for the clinical trials team in regulatoryaspects of clinical trials.Develop standard operating procedures asneeded.Assist in the auditing and monitoring of studies asneeded.MinimumQualifications:Bachelor’s degree in related disciplinerequired.Five(5) years of related experiencerequired.Additional education may substitute for required experience, tothe extent permitted by the JHU equivalencyformula.JHUEquivalency Formula:18graduate degree credits (semester hours) may substitute for oneyear of experience. For jobs where equivalency is permitted, up totwo years of non-related college course work may be applied towardsthe total minimum education/experience required for the respectivejob.PreferredQualifications:Related Master’s Degreepreferred.Special Knowledge, Skills, andAbilities:Musthave familiarity with NIH, GCP, OHRP, and federal regulations forhuman subject participation in clinicalresearch.Excellent verbal and communication skills arerequired.Technical qualifications or specializedcertifications:SOCRA, Certified IRB Professional or other clinical researchcertifications arepreferred.Classified title: Sr. Research Program CoordinatorIIWorking title:Sr.Research Program Coordinator II -RegulatoryRole/Level/Range: ACRP37.5/E/04/MCStarting Salary Range: $45,195.12 – $62,225.04 (commensuratewith experience)Employee group: Full timeEmployee Status: ExemptSchedule: Monday-Friday – 8:30am-5:00pm 37.5hrs/Wk-Location: CRB II, 4M – 1550 Orleans St., BaltimoreMDDepartment name: 10003153-SOM Rad Onc Clinical TrialsGroupPersonnel area (School): SOM – School ofMedicineThe successful candidate(s) for this position will be subject toa pre-employment background check.If you are interested in applying for employment with The JohnsHopkins University and require special assistance or accommodationduring any part of the pre-employment process, please contact theHR Business Services Office [email protected] For TTYusers, call via Maryland Relay or dial 711.The following additional provisions may apply dependingon which campus you will work. Your recruiter will adviseaccordingly.During the Influenza (“the flu”) season, as a condition ofemployment, The Johns Hopkins Institutions require all employeeswho provide ongoing services to patients or work in patient care orclinical care areas to have an annual influenza vaccination orpossess an approved medical or religious exception. Failure to meetthis requirement may result in termination of employment.The pre-employment physical for positions in clinical areas,laboratories, working with research subjects, or involvingcommunity contact requires documentation of immune status againstRubella (German measles), Rubeola (Measles), Mumps, Varicella(chickenpox), Hepatitis B and documentation of having received theTdap (Tetanus, diphtheria, pertussis) vaccination. This may includedocumentation of having two (2) MMR vaccines; two (2) Varicellavaccines; or antibody status to these diseases from laboratorytesting. Blood tests for immunities to these diseases areordinarily included in the pre-employment physical exam except forthose employees who provide results of blood tests or immunizationdocumentation from their own health care providers. Anyvaccinations required for these diseases will be given at no costin our Occupational Health office.Equal Opportunity EmployerNote: Job Postings are updated daily and remain online untilfilled.EEO is the LawLearn more:https://www.eeoc.gov/sites/default/files/migrated_files/employers/poster_screen_reader_optimized.pdf School of Medicine -East Baltimore Campus Administrative Not specified Full Time jobs in Baltimore Facebook Academic Affairs Not specified Full Time jobs in Baltimore Salary Not Specified Similar jobs You need to sign in or create an account to save Maryland, United States Johns Hopkins University Save Research Data Analyst Research Administration Not specified Full Time jobs in Baltimorelast_img

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