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Clinical Research Coordinator - Georgetown University Medical Center
The Clinical Research Coordinator I (CRCI) acts as the primary coordinator on multiple transplant (liver, kidney, pancreas, bowel) and GI clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Director. Given that the role is an entry level position, s/he coordinates low to moderate complexity studies and advances to higher complexity studies with more tenure in the department. The incumbent supports the research on-call rotation among the research team to support transplant surgeries and enrollments. Working under the supervision of the Director who will delegate appropriate tasks to the CRC, the Clinical Research Coordinator I has additional duties that include but are not limited to:
Responds to all pages regarding screening and possible enrollment in clinical trials, becoming available for study related activities on the phone, email and in person.
Monitors all activity of on-site reviewers for consistency and correctness in the application of standards.
Under supervision of manager, prepares and schedules audits with pharmaceutical sponsors and other monitors for trials, maintaining compliance with all research related requirements to ensure ongoing grant approvals.
Establishes independent guidelines for protocol adherence, and in conjunction with Principal Investigators: screens, recruits, and selects patients for studies, ensuring that eligibility requirements and protocol adherence.
Reviews all patient medical records and data within the designated time frames and established guidelines, standards policies and procedures.
Under supervision of a physician and manager, prepares all regulatory documents in compliance with protocols, IRB submissions and informed consents.
Reports and forwards all amendments and adverse events to IRB and sponsor, maintaining communication with funding sources and manager.
Produces case documentation in approved manual or electronic format while maintaining required standards and protocols.
Independently collects, prepares, organizes, and enters data in case report forms and databases as appropriate.
Collaborates with staff within the department as well as throughout the hospital to obtain data and implement operational standards, ensuring confidentiality of data for investigational activities.
Communicates with patients, families, medical staff, caregivers, and third party payers, as necessary about financial responsibility for all aspects of medical regimen.
Conducts concurrent chart review of selected patient populations and assesses the appropriateness of the research-related care, diagnostic testing, and research procedures, under the supervision of a physician.
Prepares patients for office procedures, observing and documenting research protocols, as appropriate.
Communicates research plan of care with patients, families, medical staff, and care givers as appropriate.
Analyzes and abstracts data from the medical under the direction of Principal Investigator(s) for reporting to sponsors, governing bodies, and academic publication.
Maintains established departmental policies and procedures, attending required meetings and participating in committees as requested.
Performs quality control functions of assigned area, as directed and maintains data tracking in accordance with various accrediting and governing bodies.
Bachelor's degree preferred or Associate's degree with 1 - 2 years' experience; An equivalent combination of education and experience may be substituted
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
Experience in a healthcare setting
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Internal Number: JR07906
About Georgetown University
Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit University. Georgetown is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world.