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Clinical Research Coordinator, Department of Radiology – 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 and the Jesuit principle of cura personalis - care of the whole person. GUMC consists of the School of Medicine, the School of Nursing & Health Studies, Georgetown Lombardi Comprehensive Cancer Center, and Biomedical Graduate Research and Education.
The Department of Radiology provides services in diagnostic radiography, digital mammography, fluoroscopy, diagnostic angiography, computed tomography, magnetic resonance imaging, ultrasound, breast MRI, nuclear medicine, interventional and neurointerventional radiology.
The Clinical Research Coordinator (CRC) coordinates and participates in grant-funded research and/or industry-sponsored clinical research studies in the Department of Radiology, and administers a variety of complex activities involved in the collection, compilation, and documentation of clinical research data. S/he performs study tasks such as all regulatory documentation, subject recruitment, study enrollment tasks, study conduct, data management, and study closeout. The CRC ensures efficient participant flow, manages recruitment pipelines, oversees regulatory compliance, and ensures overall logistical progress on the project. Reporting to the Clinical Research Manager and Principal Investigators, the CRC has duties that include but are not limited to:
- Completes IRB submission of protocol, including preparation of ICF and HIPAA documents, advertisements, and other documents as needed.
- Assists when assigned in budget development working with other departments as indicated.
- Facilitates study contract through the grants and contracts office.
- Develops screening/recruitment/retention plan for participants with what is allowable under HIPAA rules.
- Coordinates study procedures with necessary departments.
- Develops study flow sheets and/ or source documents as indicated.
- Ensures the presence of all study supplies and equipment for study initiation.
- Trains or arranges for training of staff on study specific procedures as indicated.
- Implements recruitment plan within study budget, including advertisements, chart reviews, and doctor referrals.
- Completes all screening visits in an order to maximize budget, including administration of informed consent, review of inclusion and exclusion criteria, and scheduling of all screening tests/procedures.
- Completes documentation of screening visits through accurate and complete source documentation and subject screening logs.
- Plans for subject tracking through the entire protocol.
- Schedules study visits with the subject, PI as required, and other necessary departments, such as the CTU/GCRC and radiology.
- Completes essentials of the study visit within the realm of non-licensed personnel, such as assessment of concomitant medications, AE, drug dispensation, and data collection as per protocol.
- Completes all documentation of the study visit.
- Maintains all regulatory documentation and record keeping in the regulatory binder, including processing of protocol amendments, IRB annual renewal, ICF changes, 1572 changes, and others as indicated.
- Completes all adverse event reporting following institutional policies.
- Ensure adherence to protocol.
- Maintains all drug/device accountability including documentation of dispensation, returns, and subject compliance.
- Coordinates with the sponsor, PI, and other departments, as indicated all study monitoring visits; and completes all queries generated form the visit in a timely manner.
- Tracks all study payments as assigned.
- Interfaces with faculty, collaborators, and administrative staff to report project progress and troubleshoot barriers; and serves as point of contact for external investigators/departments looking to utilize Radiology services.
- Verifies that all subject visits, including follow-up, are complete and all associated adverse events are resolved, up-to-date, and reported.
- Completes all source documents, Case Report Forms, and queries, and assures they are ready for close-out.
- Completes all regulatory closeout requirements, including notification of the IRB, retention of documents, final drug/device closeout, and clinical supply return.
- Exemplifies Guest and Staff relations standards in all activities.
- Promotes confidentiality concerning patient and family issues.
- Responds to patient /staff requests in a reasonable, courteous, manner.
- Demonstrates consistently positive interpersonal skills and communications.
- Bachelor’s degree in a scientific or related field
- 3 to 5 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 interpersonal, verbal and written communication skills
- Ability to operate effectively in a changing organizational and technological environment
- Strong working knowledge of FDA (Food and Drug Administration), NCI (National Cancer Institute), OHRP (Office for Human Research Protections), and/or ICH GCP (International Council for Harmonisation Good Clinical Practice)
- Ability to interpret and apply GUMC policies and federal, state, and local regulations
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