Program Manager C - JOBS.ac.kr(잡스) - 대한민국 최대 석박사 채용정보, 잡스!

{"job":{"jobId":1212350,"fk_accountId":null,"fk_organizationId":469,"fk_adminAccountId":null,"title":"Program Manager C","description":"\n\nUniversity Overview\n\n\nThe University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News &amp; World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn’s distinctive interdisciplinary approach to scholarship and learning.\n\n\nPenn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.\n\n\nThe University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.\n\n\nJob Profile Title\n\n\nManager Research Project C\n\n\nJob Description Summary\n\n\nThe Abramson Cancer Center (ACC) is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and treatment of cancer. The ACC Clinical Research Unit (CRU) is instrumental in the development and implementation of cancer clinical trials that offer cutting-edge oncology treatments. The ACC CRU is currently comprised of 13 Research Teams that support disease/discipline specific cancer programs within the ACC.\n\n\nThe Program Manager position will directly report to the Physician Leader of the Abramson Cancer Center (ACC), Clinical Research Unit (CRU) - Leukemia Research Team and indirectly report to the CRU Central - Associate Director of Clinical Research Operations. The successful candidate will work closely with Physician leader of this CRU Leukemia Research Team to oversee all aspects of the clinical research portfolio being performed for their research program. He/she will oversee the start-to-end processes for study start-up and ongoing study management. This includes assisting with study feasibility and selection, prioritization of the team’s work, working closely with the CRU Regulatory coordinators to manage, review and initiate trials to ensure competitive activation and enrollment timelines. The Program Manager is expected to actively manage ongoing research projects, troubleshoot operational issues on a daily basis and assist with any and all aspects of their team’s work during absences or when a specific team member’s workload exceeds capacity (including, but not limited to, managing the research team protocol portfolio including budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors).\n\nTHIS POSITION IS CONTINGENT UPON FUNDING\n\n\nJob Description\n\n\nThe Program Manager will work closely with major internal (PI, CRU Central – Operations, Regulatory, Education/QA, Budget, Legal, Finance, Billing Compliance, Infusion/CHPS, Investigational Drug Services/Pharmacy) and external (sponsors, facilities, CROs, Subcontractors, Collaborators) stakeholders to develop project plans and support day to day operations of clinical research proposals for their team.  The Program Manager will work with Investigators and data informatics teams/programs to ensure the Research Program is supporting the patient population they are studying.\n\n\nThe Program Manager for the Leukemia Research Team in the CRU will oversee Phase I-IV clinical trials.  Additional activities may include recruitment, and enrollment of patients according to protocol requirements for their team.  He/she may schedule patient visits and any necessary testing, monitor patients per protocol requirements and ensure adherence to protocol requirements, organize and maintain all documentation required by the sponsor or CRO- includes source documentation, case report forms, and research charts.  He/she may collect, review and report study data, complete case report forms and resolve data queries, process and ship study specimens including blood, urine and tissue samples, participate in initiation, monitoring, audit and close-out visits, coordinate study team meetings, disease site and/or discipline group meetings, and ongoing protocol training/compliance meetings.  The Program Manager will assist in the development/maintenance of study specific case report forms and source document tools, show vigilance in patient safety, protocol compliance and data quality.   \n\n\nAdhere to the requirements of the University of Pennsylvania, GCP, FDA and all applicable regulatory bodies.\n\n\nSpecific responsibilities include (but are not limited to):\n\n\n<ul>\n<li>Supervising the clinical research nurse(s), clinical research coordinator(s), and research assistants for the team. This will include recruiting, interviewing, hiring, training, performance management, and paid time off for the staff. Conduct weekly or every other week meetings with team members to review the status of their studies in detail, items that are outstanding, and troubleshooting issues needing to be addressed.</li>\n<li>Work with research team physician investigator leaders to ensure balanced staff workload, select and optimize study portfolio for currently available resources in conjunction with available patient population statistics, anticipate any need for the group to hire additional staff based on data analysis and develop a business proposal to reflect any needs.</li>\n<li>Work with CRU Central to facilitate the initiation of new trials from feasibility review, new study submission, through activation, including tracking of protocols, contracts, and budgets through the start-up process, working with sponsor to schedule SIV’s, and maintain communication with study teams and collaborative UPHS departments regarding progress.</li>\n<li>Perform group-specific regulatory activities, such as site selection visits, document completion (site selection questionnaires, 1572’s and financial disclosure forms), and IRB and IND report completion (with investigator input), including AE reports, deviations, CRs and modifications.</li>\n<li>Work in conjunction with the ACC Budget Specialist, Billing Compliance staff, and Finance office to develop clinical trial budgets. Communicating any specialized study budget needs to the budget specialist, including any changes necessitated by a protocol modification and assisting the financial department by working with the study team to provide study visit information and invoiceable items as needed to the Finance Office.</li>\n<li>Work closely with the Regulatory Coordinators of the CRU to manage review and startup of trials. Submit complete Initial and Amendment study packets and logistical review forms to regulatory, along with appropriate study contacts.</li>\n<li>Work with team members to ensure accurate and timely data entry into electronic Clinical Trials Management System (Velos), including study status, screening logs, serious adverse events and subject enrollment status. The Program Manager may also have primary study coordinator responsibility for at least 1 study.</li>\n<li>Closely monitor and report to their team the status of all studies within their group, including accrual, data entry, query resolution, deviations and patient issues, identifying and addressing any issues</li>\n<li>Collaborate with CRU Central:\n\t<ul>\n<li>Review of program metrics (performance, portfolio, enrollment)</li>\n<li>Timely communication of significant challenges encountered by the team</li>\n<li>Participate in CRU Central leader meetings and serve on subject matter expert work groups as needed to enhance overall workflow efficiencies and quality of research</li>\n</ul>\n</li>\n</ul>\n\n\nQUALIFICATIONS\n\n\nEffective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations. And:\n\n\nMaster’s Degree and 5-7 year of related experience (or equivalent combination of education and experience) preferred; or Bachelor’s Degree required and 7-10 years of related experience. Oncology clinical research experience preferred.  5+ years of Good Clinical Practices (GCP) related experience required; thorough knowledge relevant regulations for the conduct of clinical trials including Title 21 Code of Federal Regulations (CFR), International Conference of Harmonization (ICH) Guidelines.  Knowledge of funding policies, NIH, and other grant procedures is desired.\n\n\nTHIS POSITION IS CONTINGENT UPON FUNDING\n\n\nJob Location - City, State\n\n\nPhiladelphia, Pennsylvania\n\n\nDepartment / School\n\n\nPerelman School of Medicine\n\n\nPay Range\n\n\n$72,837.00 - $138,391.00\n\n\nAffirmative Action Statement \n\n\nPenn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.\n\n\nSpecial Requirements \n\n\nBackground check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.\n\n\n","pdfUrl1":null,"location":"Pennsylvania, United States","location1":"북아메리카","location2":null,"location3":null,"type":"2","applyUrl":"https://wd1.myworkdaysite.com/en-US/recruiting/upenn/careers-at-penn/job/Perelman-Center-for-Adv-Medicine/Program-Manager-C_JR00017633","fileUrl1":null,"fileUrl2":null,"fileUrl3":null,"fileUrl4":null,"fileUrl5":null,"fileUrl6":null,"fileUrl7":null,"workingHour":"Full Time","contractType":"Permanent","salary":null,"original_id":"UNI|224897","original_domain":"https://www.timeshighereducation.com/unijobs","original_url":"https://www.timeshighereducation.com/unijobs/listing/224897/program-manager-c/","original_isPremium":"false","closeType":2,"closedAt":null,"requireEducation":0,"managerTel":null,"managerFax":null,"managerEmail":null,"managerName":"UNIVERSITY OF PENNSYLVANIA","managerPhone":null,"managerAddress":null,"log_hit":1,"log_like":0,"publishState":1,"organizationName":null,"organizationName_en":null,"organizationName_alt":null,"createdAt":"2020-09-09T00:00:00.000Z","updatedAt":"2020-09-18T13:17:16.000Z"},"organization":{"organizationId":469,"lv1Id":null,"lv2Id":null,"name":"University of Pennsylvania","name_en":"University of Pennsylvania","name_alt":",","introduction":"Given its status as one of the nine original Colonial Colleges – institutions established before the US became a sovereign nation after the American Revolution – and a founding member of the Association of American Universities, it is no surprise the University of Pennsylvania (Penn) claims to be the first fully fledged (multi-faculty) “university” in the USA.&nbsp;Though Penn’s origins date back to 1740, it was until 1749 when Benjamin Franklin published his famous essay, Proposals Relating to the Education of Youth, circulated it among Philadelphia’s prominent citizens, and organized 24 trustees to form an institution of higher education based on his proposals. It was 30 years later when Penn was granted university status. Since then, Penn has expanded into a sprawling 302-acre campus with 200 buildings. It boasts many notable “first” landmarks on campus including the country’s first student union, double-decker college football stadium, and the world’s first collegiate business school – The Wharton School.&nbsp;Penn’s prowess is not restricted to just infrastructure. The university has an exhaustive list of notable alumni from all walks of life. Penn has affiliations with over 25 Nobel Laureates including physicist Raymond Davis Jr and economist Lawrence Klein, and has accounted for numerous heads of state. Ninth president of the USA, William Henry Harrison, trod the boards at Penn in 1791, while Nnamdi Azikiwe – former president of Nigeria – and Kwame Nkrumah – former prime minister and president of Ghana – both gained multiple degrees from the institution. Noted modernist poets and friends Ezra Pound and William Carlos Williams are among the literary luminaries from the institution.","logoImg":"","logoImgSquare":"https://s3.ap-northeast-2.amazonaws.com/jobs.ac.kr/dev/images/sakjdakljda_1160966006540.png","homepageUrl":"https://www.upenn.edu/","infoUrl":"https://www.timeshighereducation.com/world-university-rankings/university-pennsylvania","country":"US","state":"Pennsylvania","location":"북아메리카","address":"3451 Walnut Street, Philadelphia, Philadelphia, Pennsylvania, 19104, United States","phoneNumber":"+1 215-898-5000","faxNumber":"","type":1,"univType1":"대학","univType2":"대학교","univType3":"","univType4":"본교","establishedAt":"1740-01-05T00:00:00.000Z","count_majors":null,"count_students":null,"meta_competitiveness":"","publishState":1,"updatedAt":"2020-03-26T11:29:50.000Z","createdAt":"2020-03-04T20:13:07.000Z","default_1_bannerImage":null,"default_1_bannerImageMobile":null,"default_2_bannerImage":null,"default_2_bannerImageMobile":null,"default_3_bannerImage":"https://s3.ap-northeast-2.amazonaws.com/jobs.ac.kr/dev/images/PENNSYLVANIA_20973628189.jpg","default_3_bannerImageMobile":"https://s3.ap-northeast-2.amazonaws.com/jobs.ac.kr/dev/images/PENNSYLVANIA_1152179661653.jpg"}}