Clinical Research Coordinator II, Center for Translational Transplant Medicine Georgetown University Medical Center
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Clinical Research Coordinator II, Center for Translational Transplant Medicine - Georgetown University Medical Center
The Clinical Research Coordinator II (CRCII) acts as primary coordinator on multiple high-complexity clinical research studies, under the oversight of the Principal Investigator (PI). They are responsible for the implementation of their assigned portfolio of studies - for example, Institutional Review Board (IRB) submissions, data abstraction/entry/management, participant screening and enrollment, assuring participant movement through the research protocols compliantly, timely communication and reporting to the sponsors/Contract Research Organizations (CROs) and study associated IRBs (local or central). Given required work experience, this is an intermediate level position in the Clinical Research Coordinator family.
Reporting to the Research Director, and conducting the studies under direct oversight of the Principal Investigators (PIs), the CRCII has duties that include but are not limited to:
Provides primary and back-up support to manage multiple industry-sponsored and/or non-industry sponsored studies conducted at GUMC.
Assures participants are managed compliantly through the protocol and visits occur within specified windows.
Schedules study visits, including ancillary departments as needed.
Assures the back-up coordinator is well-versed and trained on the Protocol in the event the primary coordinator is unavailable.
Identifies adverse events and serious adverse events, and works with the PI to assess severity and relatedness, reporting the events appropriately and efficiently to sponsor and the IRB.
Assures source documentation is attributable, legible, contemporaneous, original, and accurate.
Maintains a master regulatory file including required regulatory documents - e.g., FDA Form 1572, IRB correspondence, and originally-signed informed consent forms.
Coordinates and leads on-site or remote study monitoring visits, and supports the PI in the event of an FDA inspection.
Assures OnCore is updated per institutional policy, and that internal GUMC/ departmental invoicing practices are current.
Attends internal orientation to study budget meetings and quarterly budget reviews as scheduled.
Liaises with sponsor regarding site management, including data management and query resolution in a timely matter.
Maintains consistent and clear communication with Principal Investigators and sponsors/CROs.
Identifies and screens potential research participants to determine initial eligibility and interest in participation, while maintaining privacy protections.
Vets eligibility with the PI or Sub-Investigator prior to enrollment.
Consents participants according to MGUH policy as well protocol guidelines.
Schedules screening tests/procedures and study visits per the protocol and MGUH practices.
Leads the site selection process through feasibility review to site initiation visit.
Completes the initial IRB submission (in conjunction with the regulatory coordinator, as applicable) of the protocol, informed consent form (ICF), HIPAA documents, and other study-related materials.
Works 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 Director.
Coordinates study start-up with needed GUMC ancillary departments, such as the Clinical Research Unit, Lab, and Radiology.
Assures appropriate training occurs and is documented of all study personnel, including attendance of sponsor-required meetings, e.g., Investigator Meetings.
Develops study job aides, checklists and source documents as needed to assure protocol compliance.
Verifies all participant visits are complete and that all associated safety reporting has been done, including adverse event reporting.
Assures data entry and query resolution is complete, and that source documentation is current.
Assures OnCore is current and all study invoicing is complete and verifies financial closure with the Director.
Conducts the sponsor closeout visit and completes regulatory closeout, including IRB closure, drug/device/supply/equipment return, and records retention per institutional policy.
Acts 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, International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline, and institutional policies.
Complies with all GUMC and clinical trial management policies, assuring compliance with Medicare clinical trials billing procedure.
Assures sponsor and institutional training is current - including CITI, COI, IATA, University Lab and Biological Safety training, and MedStar required mandatories - and that EHS work status is updated annually
Attends a minimum of 6 GUMC research meetings each year.
Abides by departmental SOPs and procedures, including effort reporting.
Rotates 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, assures adequate training has occurred and is documented to staff the call rotation.
Bachelor's degree in a scientific or related field
At least 3 years CRCI or equivalent clinical 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), and a familiarity with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline.
Strong organizational, critical thinking, and problem-solving skills
Working knowledge of clinical trials contracting and budgeting, including understanding of Medicare Coverage Analysis (MCA) and clinical trials billing compliance - both industry and non-industry.
Excellent demonstrated interpersonal, verbal, and written communication skills
Strong proficiency in Microsoft, Google, data capture systems, electronic medical records, and other computer applications.
Experience with OnCore, a Clinical Trial Management System
Certified clinical research certification (SoCRA or ACRP) or must obtain within one year of eligibility
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