Clinical Research Coordinator, Central Research Support Services

Employer
Georgetown University
Location
Washington D.C.

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Administrative Jobs
Academic Affairs, Research Staff & Technicians, Institutional & Business Affairs, Clerical & Administrative Support


Clinical Research Coordinator, Central Research Support Services - Georgetown University Medical Center

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.

Requirements

Clinical Research Coordinator, Central Research Support Services - Georgetown University Medical Center

Georgetown University Medical Center (GUMC) is an internationally recognized academic medical center whose missions of research, teaching and patient care are carried out with a strong emphasis on community outreach. The Division of Wound Healing and Department of Plastic Surgery, as well as other departments at GUMC, are conducting multiple clinical research studies.

The Clinical Research Coordinator supports clinical research studies within the Division of Wound Healing and Department of Plastic Surgery by coordinating and conducting grant funded research and/or industry sponsored clinical research. Reporting to the Manager of Central Research Support Services and responsible to the PI, the Clinical Research Coordinator has duties that include but are not limited to:

Study Conduct
  • Schedule study visits with the subject and Pl as required, and other necessary departments such as the CRU and radiology
  • Complete essentials of the study visit within the realm of non-licensed personnel. This includes, assessment of concomitant medications, AE, drug dispensation, and data collection as per protocol
  • Complete all documentation of the study visit
  • Maintain all regulatory documentation and record-keeping in the regulatory binder. including processing of protocol amendments, IRS annual renewal, ICF changes, 1572 changes and others as indicated
  • Complete all adverse event reporting following institutional policies
  • Ensure adherence to protocol
  • Maintain all drug/device accountability including documentation of dispensation, returns and subject compliance
  • Perform all functions in conjunction with Good Clinical Practice (GCP), and in accordance with all District of Columbia, federal laws, and Food & Drug Administration (FDA) regulations, as well as GUMC's philosophy, policies and procedures


Study Closeout
  • Verify that all subject visits, including follow-up, are complete and that all associated Adverse Events are resolved, up-to-date, and reported
  • Complete all source documents, Case Report Forms and queries are complete and ready for closeout
  • Complete all regulatory closeout requirements, including notification of the IRS, retention of documents, final drug/device closeout, and clinical supply return


Customer Service
  • Exemplify Guest and Staff relations standards in all activities
  • Promote confidentiality concerning patient and family issues
  • Respond to patient /staff requests in a reasonable, courteous manner
  • Demonstrate consistently positive interpersonal skills and communications
  • Coordinate with schedulers to schedule patients within study visit timeline


Qualifications
  • Bachelor's degree in a scientific or related field
  • At least 1 to 3 years of clinical research experience
  • In-depth knowledge of clinical research contracts and grants, clinical trials, protocols, FDA regulations, and complex visit structures
  • Exceptional analytical skills to address complex and non-routine issues requiring the development of innovative solutions
  • Excellent demonstrated interpersonal, verbal and written communication skills
  • Ability to operate effectively in a changing organizational and technological environment
  • Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
  • Ability to interpret and apply GUMC policies and federal, state, and local regulations


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 cover letter and resume for each position of interest for which you believe you are qualified. These 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 202-687-4798 or [email protected].

Need some assistance with the application process? Please call 202-687-2500. 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 wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu or view the online interactive benefits guide for more information.


To apply, visit https://apptrkr.com/2498627





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