Clinical Research Coordinator II - 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.RequirementsClinical Research Coordinator II - Georgetown University Medical Center
The Clinical Research Coordinator II
serves as project manager of one multi-site NIH-funded clinical trial examining whether a culturally sensitive genetic testing program for living kidney donor candidates of African ancestry improves informed treatment decision-making. With oversight by the Principal Investigators, and reporting to the Clinical Research Supervisor, the Clinical Research Coordinator II
has duties that include but are not limited to:Study Initiation
- Lead the site selection process through feasibility review to site initiation visit.
- Complete the initial IRB submission of the protocol, informed consent form (ICF), HIPAA documents, and other study-related materials.
- Work with necessary GUMC departments and systems (GUPass) as needed to assure the contract/budget is routed and executed, with input into the MCA and budget with the PI, under direct supervision of the Supervisor.
- Coordinate study start-up with needed GUMC ancillary departments
- Assure appropriate training occurs and is documented of all study personnel including attendance of sponsor-required meetings
- Develop study job aides, checklists and source documents as needed to assure protocol compliance.
- Identify and screen potential research participants to determine initial eligibility and interest in participation, while maintaining privacy protections; and vet eligibility with the PI or Sub-Investigator prior to enrollment.
- Consent participants according to MedStar Georgetown University Hospital (MGUH) policy, as well protocol guidelines.
- Schedule screening tests/procedures and study visits per the protocol and MGUH practices.
- Provide primary and back-up support to manage multiple industry-sponsored and/or non-industry sponsored studies conducted at GUMC.
- Assure participants are managed compliantly through the protocol, and that visits occur within specified windows.
- Schedule study visits, including ancillary departments as needed.
- Assure the back-up coordinator is well-versed and trained on the Protocol in case the event that primary coordinator is unavailable.
- Identify any adverse events and serious adverse events, work with the PI to assess severity and relatedness, and report the events appropriately and efficiently to sponsor and the IRB.
- Assure source documentation is attributable, legible, contemporaneous, original, and accurate.
- Maintain a master regulatory file, including required regulatory documents - such as the FDA Form 1572, IRB correspondence, and originally-signed informed consent forms.
- Coordinate and lead on-site or remote study monitoring visits; and support the PI in the event of an FDA inspection.
- Assure OnCore is updated per institutional policy and that internal GUMC/ departmental invoicing practices are current.
- Attend internal orientation to study budget meetings and quarterly budget reviews as scheduled.
- Liaise with sponsor regarding site management, including data management and query resolution in a timely matter.
- Maintain consistent and clear communication with Principal Investigators and sponsors/CROs.
- Verify all participant visits are complete, and that all associated safety reporting has been done, including adverse event reporting.
- Assure data entry and query resolution is complete, and that source documentation is current.
- Assure OnCore is current and that all study invoicing is complete; and verify financial closure with the Supervisor/Director.
- Conduct the sponsor closeout visit and complete regulatory closeout, including IRB closure, drug/device/supply/equipment return, and records retention per institutional policy.
- Act as mentor to new research staff on research process and regulation.
- Participate in and/or lead 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 that Biological Safety training, MedStar required mandatories, and EHS work status is updated annually.
- Attend a minimum of six (6) GUMC research meetings each year.
- Abide 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 Supervisor/Director, assure adequate training has occurred and is documented to staff the call rotation.
- Bachelor's degree in a scientific or related field
- At least 2 to 4 years of research experience [An equivalent combination of education and experience may be substituted]
- Working 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 skills
- Excellent demonstrated interpersonal, verbal, and written communication skills
- Strong proficiency in Microsoft, Google, data capture systems, electronic medical records, and other computer applications
Current Georgetown Employees:
- Master's Degree in the field of social sciences, health sciences, multicultural studies, or a related field
- Experience working directly with people from diverse racial, ethnic, and socioeconomic backgrounds
- Ability to adapt communication style to multiple cultural environments
- Excellent written and verbal communication skills, and ability to present to diverse audiences
- An understanding of the issues of institutional and structural racism and bias
- Strong interest in incorporating the perspectives of communities of color in the analysis of the outcomes of clinical decision-making, and in considering the psychosocial and clinical impacts of genetic testing on communities of color
- Certified clinical research certification (SoCRA or ACRP) preferred - and is required within one year of eligibility
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]
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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
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
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
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for more information.
To apply, visit https://apptrkr.com/2481372
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