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The Clinical Research Coordinator II (CRCII) is responsible for acting as primary coordinator on multiple high-complexity clinical research studies, under the oversight of the Principal Investigator (PI). S/he is responsible for the implementation of their assigned portfolio of studies, including reporting to the sponsors/Contract Research Organizations (CROs) and study associated IRBs (local or central). The incumbent works 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. Working under the direct supervision of the Research Director and conducting the studies under direct oversight of the Principal Investigators (PIs), the CRCII has additional 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, scheduling 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 work 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 such as the FDA Form 1572, IRB correspondence, and originally-signed informed consent forms.
+ Coordinates and leads on-site or remote study monitoring visits, supporting the PI in the event of an FDA inspection.
+ 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.
+ 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, ICH GCP, 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, MedStar required mandatories, and EHS work status is updated annually.
+ Attends a minimum of 6 GUMC research meetings each year, abiding by departmental SOPs and procedures including effort reporting.
+ Verifies all participant visits are complete and all associated safety reporting has been done, including adverse event reporting.
+ Assures data entry and query resolution is complete, source documentation is current.
+ Assures OnCore is current and all study invoicing is complete, verifying financial closure with the Director.
+ 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.
+ Maintains consistent and clear communication with Principal Investigators and sponsors/CROs.
+ 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.
+ 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.
+ Bachelor's degree in a scientific or related field with 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), 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
+ 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 (Clinical Trials Management System)
+ Certified clinical research certification (SoCRA or ACRP) preferred and required within one year of eligibility
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