Sr. Research Program Coordinator – Regulatory

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 read more

Bread of Life Dinner discusses pregnant students

first_imgNotre Dame’s Center for Ethics and Culture hosted its semi-annual Bread of Life Dinner Tuesday evening in the Morris Inn. Senior Erin Stoyell-Mulholland who helped plan and run the event, said the dinner is an opportunity for undergraduate and graduate students to interact with faculty and have conversations about issues related to the protection and support of life in the context of a brief lecture. Tuesday’s lecture featured speaker was Erin Hoffmann Harding, vice president for student affairs, who spoke on the topic of “Promoting a Culture of Life at Notre Dame.”Hoffmann Harding said she wanted to start by dispelling the notion that Notre Dame imposes disciplinary action on pregnant students — a myth she said she has heard repeated by many people across campus from students to hall staff.“This issue is one of our biggest challenges and something I am particularly passionate about,” Hoffmann Harding said.Hoffmann Harding said Notre Dame offers a wide variety of tools to help with planned and unplanned pregnancies, in particular designated pregnancy support advocates, a pregnant and parenting student assistance fund and educational online resources.“As a Catholic university, Notre Dame is committed to life and to offering students resources that support the choice of life,” Hoffmann Harding said.Students can anonymously receive pregnancy tests through University Health Services or the local Women’s Care Center if they are uncomfortable with turning to an official school organization, Hoffmann Harding said. She also said that Notre Dame takes pains to include males in the pregnancy support process, especially since the fathers are often students themselves.The question of where students can find help is crucial, Hoffmann Harding said, and options range from the emotional and spiritual support of Saint Liam’s counseling services, campus ministry and hall staff to monetary assistance from the office of financial aid.“We must be empathetic, non-judgemental and good listeners,” Hoffmann Harding said. “We want to support the choice of life.”Hoffmann Harding showed a video produced by Notre Dame, which showcased the stories of former students who had unexpectedly become pregnant while they were undergraduates in school. The students spoke about the initial fear and uncertainty they experienced, but also talked about how they were able to successfully finish their educations and form families with the support of the university.There was an informal question and answer session after the talk finished and the discussion primarily focused on raising student awareness of the issue available help for unplanned pregnancies. Suggestions from the audience included placing informational posters on pregnancy support resources in the bathrooms of resident halls in similar manner to how Georgetown University advertises their own pregnancy assistance program.Hoffmann Harding said the University is continually looking for new ways to improve their support for pregnant students and she appreciates recommendations and ideas from students and faculty.Tags: Bread of Life Dinner, Erin Hoffmann Harding, Notre Dame, Notre Dame’s Center for Ethics and Culture, pregnancy, University Health Serviceslast_img read more

Summer nights

first_imgDay tempsBased on preliminary studies of locations with at least 60 years of climate data, only 9 locations had unusually high average daily maximum temperature, which typically means daytime temperature highs. These 9 included the urban stations of Atlanta, which had the fifth warmest average daily high, and Athens, which had its third warmest average daily high. Columbus had its warmest ever. Brunswick – McKinnon had its third warmest. And Savannah tied its third warmest ever.Only four rural locations had unusually high average daily maximum temperature. Waynesboro had its warmest average daily high in 75 years of records. Brooklet experienced its warmest in 84 years of records. It was the second warmest in Sunnyside/Waycross in 101 years of records. Alma experienced its third warmest in 62 years of records. AC upAir conditioning cooling demands for buildings were above normal statewide. Cooling demand was 28 percent above normal in Atlanta, 26 percent for Athens, 23 percent for Columbus, 21 percent for Macon, 23 percent for Augusta, 18 percent for Savannah, 16 percent for Alma, and 18 percent for Brunswick. Compared to last summer, cooling demand was 27 percent in Columbus, 23 percent higher in Atlanta, 19 percent in Macon, 17 percent in Augusta, 16 percent in Athens, 15 percent in Savannah, 13 percent in Brunswick, and 12 percent in Alma.There is a high probability that winter will be warmer and drier than average. The ocean-atmosphere system is expected to remain in a La Niña pattern, which normally brings a warm and dry winter to Georgia. The La Niña pattern is often the pattern that leads to a summertime drought. Thus, there is an increased probability that Georgia could experience a drought in 2011.Updated weather conditions can be found at www.georgiaweather.net. This past summer was one of the warmest on record for Georgia. It wasn’t that the daytime high temperatures were that unusual; it was the warm nighttime temperatures that set records. Meteorologists and climatologists define summer as the months of June, July and August. Almost all locations in Georgia had record to near-record warm nights for this time period. Night tempsLocations with at least 60 years of climate data that experienced record-setting warm average daily minimum temperatures, which typically indicates nighttime temperatures, included Atlanta (132 years of climate data), Jasper (68 years), Gainesville (109 years), Toccoa (107 years), Athens (67 years), Augusta – Bush Field (67 years), Waynesboro (75 years), Louisville (98 years), Macon (80 years), Columbus (63 years), Camilla (70 years), Moultrie (83 years), Brooklet (84 years), and Alma (62 years). Locations with at least 60 years of climate data that experienced the second warmest average daily minimum temperatures included Cedartown (73 years of climate data), Tifton (89 years), Brunswick – McKinnon (62 years), and Sunnyside/Waycross (101 years). The third warmest average daily minimum temperatures were reported at Clayton (109 years), Lafayette (68 years), and Milledgeville (104 years). The fourth warmest average summer nights were recorded at Eastman (105 years) and Savannah (137 years).A month, season or year that is warm or cold tells us very little about global warming or climate change. Global warming is seen in long-term trends. However, warm nighttime temperatures are what we expect with human-induced global warming. If these abnormally warm nights continue over the next several years, then we have good evidence supporting human-induced global warming or climate change.last_img read more

UCL Round of 16: Borussia Dortmund v Tottenham preview

first_imgBorussia Dortmund need to do something they have never done before and overturn a three-goal deficit.Dortmund may never have overturned a three-goal deficit, but they came mighty close against Real Madrid in the quarter-finals five years ago.That second-leg showing in 2013/14 can serve as inspiration for the hosts – who are in bullish pre-match mood – but Tottenham, buoyed by recent good results against BVB and with the prize of only a second UEFA Champions League quarter-final in their history within reach, should have enough nous to stave off a fightback.Possible line-upsDortmund: Bürki; Wolf, Akanji, Zagadou, Diallo; Delaney, Witsel; Sancho, Reus Guerreiro; GötzeOut: Piszczek (foot)Doubtful: Pulišić (muscle)Misses next match if booked: WeiglTottenham: Lloris; Alderweireld, Sánchez, Vertonghen; Aurier, Sissoko, Wanyama, Rose; Eriksen, Son, KaneOut: Alli (hamstring), Trippier (fitness)Doubtful: Dier (illness), Winks (hip)Misses next match if booked: Alderweireld, Lamela, SonKey battleAkanji v Kane: Dortmund sorely missed the injured Manuel Akanji’s athleticism and anticipation in the Wembley first leg.To stand any chance of progression to the quarter-finals, BVB cannot afford to concede an away goal; for that to be the case, the fit-again Swiss defender must shackle Harry Kane, who has scored three goals in as many appearances against Dortmund.Form guideDortmundLast game: Augsburg 2-1 Dortmund (01/03)Form: LWDLDDDWWWTottenhamLast game: Tottenham 1-1 Arsenal (02/03)Form: DLLWWWWLLWLucien Favre, Dortmund coach“We can’t talk about [beating Atlético 4-0 earlier this season]. Every game is different. The first leg is done and this is a different situation. We know we can score goals, but we have to play very cleverly. Of course, the most important thing is to produce a top performance. Anything is possible. We know it’s tough, but you never know.”Mauricio Pochettino, Spurs manager“It’s a great opportunity to play and go through to the next round in an important competition like the Champions League. It’s going to be a tough game. We need to forget the first leg. It’s important to start at a very good level – be aggressive, fight from the beginning, high tempo, that’s key.” –Source: UEFA –Source: UEFAlast_img read more