Location: Washington,DC, USA
Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.RequirementsAs a top academic health and science center in the United States, Georgetown University Medical Center seeks to provide, in a synergistic fashion, excellence in education - training physicians, nurses and other health care professionals, as well as biomedical scientists - and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health. Emphasizing service, we are dedicated to the Catholic, Jesuit principle of cura personalis - care of the whole person. Our partnerships with organizations in the region strengthen our work and expand its reach. The Clinical Research Coordinator II (CRCII) is the lead coordinator on multiple transplant (liver, kidney, pancreas, bowel) and GI clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Assistant Research Manager and the Research Director. The CRCII is responsible for the implementation of their assigned portfolio of studies, including regulatory submissions, data abstraction/entry/management, participant screening and enrollment, and study management. Given the role is an intermediate level position, the coordinator will manage moderate to high-level complexity studies. The role involves supporting the research on-call rotation amongst the research team to support transplant surgeries and enrollments. Additional duties include, but are not limited to:Study ManagementProvide primary and back-up support to manage multiple industry-sponsored and/or non-industry sponsored studies conducted at GUMCAssure participants are managed compliantly through the protocol and visits occur within specified windows.Schedule study visits including ancillary departments as needed, assuring the back-up coordinator is well-versed and trained on the Protocol in the event the primary coordinator is unavailable.Identify adverse events and serious adverse events and work with the PI to assess severity and relatedness, reporting the events appropriately and efficiently to sponsor and the IRB.Assure OnCore is updated per institutional policy and that internal GUMC/departmental invoicing practices are current, attending internal orientation to study budget meetings and quarterly budget reviews as scheduled/needed.Study CloseoutVerify all participant visits are complete and all associated safety reporting has been done, including adverse event reporting.Assure data entry and query resolution is complete, source documentation is current.Assure OnCore is up to date and all study invoicing is complete, verify financial closure with the Director.Conduct the sponsor closeout visit and complete regulatory closeout including IRB closure, drug/device/supply/equipment return, and records are retained per institutional policy.GUMC/DepartmentActs as mentor to new research staff on research process and regulation.Participates in and/or leads regular research quality management activities to ensure research studies are in compliance with federal regulations, ICH GCP, and institutional policies.Comply with all GUMC and clinical trial management policies, assuring compliance with Medicare clinical trials billing procedure.Assure sponsor and institutional training is current, including CITI, COI, IATA, University Lab, and Biological Safety training, MedStar required mandatories, and EHS work status is updated annually.Attend a minimum of 6 GUMC research meetings each year, abiding by departmental SOPs and procedures including effort reporting.Rotate in the CTTM research call schedule to support 24 hours a day/7 days a week coverage of clinical trials and biorepository work.Under direction of the Director assure adequate training has occurred and is documented to staff the call rotation.Work InteractionsThe Clinical Research Coordinator II works under the direct supervision of the Assistant Research Manager in partnership with the Research Director and conducts the studies under direct oversight of the Principal Investigators (PIs). This individual will interact directly with patients, research participants, and their families. They work within the multidisciplinary team of the healthcare system and the university medical center, including the clinical research office, sponsored programs financial office, research development services, respective grants managers, and serve as primary point of contact with sponsors, CROs, and IRBs.Requirements and QualificationsBachelor's degree in a scientific or related field with at least 3 years CRC I or equivalent clinical research experience; An equivalent combination of education and experience may be substitutedWorking knowledge of the federal regulations and federal agencies including the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), as well as familiarity with the International Conference on Harmonisation Guideline for Good Clinical Practice (ICH GCP)Strong organizational, critical thinking, and problem-solving skillsWorking knowledge of clinical trials contracting and budgeting, including understanding of Medicare Coverage Analysis (MCA) and clinical trials billing compliance, both industry and non-industryExcellent demonstrated interpersonal, verbal, and written communication skillsStrong proficiency in Microsoft, Google, data capture systems, electronic medical records, and other computer applications.Experience with OnCore (Clinical Trials Management System) preferredCertified clinical research certification (SoCRA or ACRP) preferred and is expected within one year of eligibility preferredWork Mode DesignationThis position has been designated as Hybrid 4 Days. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position's mode of work designation. Complete details about Georgetown University's mode of work designations for staff and AAP positions can be found on the Department of Human Resources website: Range: The projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:Compensation is determined by a number of factors including, but not limited to, the candidate's individual qualifications, experience, education, skills, and certifications, as well as the University's business needs and external factors.Current Georgetown Employees:If you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.Submission Guidelines:Please note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.Need Assistance:If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-###-#### or ...@georgetown.edu.Need some assistance with the application process? Please call 202-###-####. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.EEO Statement:Georgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law.Benefits:Georgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.