Clinical Research Coordinator, Division of Wound Healing, Department of Plastic Surgery - Georgetow
Clinical Research Coordinator, Division of Wound Healing, Department of Plastic Surgery - 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 Clinical Research Coordinator assists physician investigators in the Division of Wound Healing, Department of Plastic Surgery, in conducting multiple clinical research studies and ensuring that all regulatory and protocol requirements are met. Reporting to the Clinical Administrator, the Coordinator has duties that include but are not limited to:
- Communicates research plan of care with patients, families, medical staff, and caregivers as appropriate; and assesses, plans, implements, and evaluates the research plan in conjunction with the patient and physician.
- Prepares patients for office procedures, observes and documents research protocols, as appropriate; and under supervision of a physician, performs enrollment assessment and research care provided, reporting observations and outcomes appropriately.
- 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; and advises faculty of research data needs and completeness of research documentation, as appropriate.
- Identifies issues/problems and makes appropriate recommendations for compliance to research billing and research review of charges and collections appropriate to clinical trial; communicates with patients, families, medical staff, caregivers, and third party payers, as necessary about financial responsibility for all aspects of medical regimen; obtains appropriate financial responsibility forms; and reconciles charges to third party payers versus clinical research trials.
- 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 database as appropriate; collaborates with staff within the department as well as throughout the hospital to obtain data and implement operational standards; ensures confidentiality of data for investigational activities; and coordinates manuscript preparation as appropriate.
- 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 the Clinical Research Operations 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; and maintains communication with funding sources and Clinical Research Operations Manager/Department Administrator.
- Monitors all activity of on-site reviewers for consistency and correctness in the application of standards; prepares and schedules audits with pharmaceutical sponsors and other monitors for research grants; maintains compliance with all research related requirements to ensure ongoing grant approvals; establishes independent guidelines for protocol adherence; in conjunction with Principal Investigators, screens, recruits, and selects patients for studies; and ensures that eligibility requirements and all pre-study laboratory/medical tests are completed.
- Performs data/statistical collection and reporting for study participants; performs quality control functions of assigned area, as directed; and maintains data tracking in accordance with various accrediting and governing bodies.
- Analyzes and abstracts data under the direction of Principal Investigator(s) for reporting to sponsors, governing bodies, and academic publication.
- Maintains established departmental policies and procedures; and attends required meetings and participates in committees as requested.
- Bachelor's degree in related field
- 1 to 3 years of related experience (research/medical/clinical)
- Excellent organizational and communication skills
- Ability to work independently as well as collaboratively with investigators and patients
- Ability to support interdisciplinary team to achieve optimal clinical and resource outcomes
- Self-directed with attention to detail
- Computer proficiency
- Preference for Basic Life Support (BLS) certification
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